Military Medicine International Journal of amsus raising the bar: extremity trauma care guest editors
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Of the 44 million diagnosed with or at risk for the disease, 68% are female, and 80 to 90% of all prosthetic users have a reduction of approximately 30% bone mineral density in their residual limb. 15,16
This is increased in females com- pared with males living with limb loss. 16 Thus, there is need *Extremity Trauma and Amputation Center of Excellence, 2748 Worth Road, Suite 29, Fort Sam Houston, TX 78234. †U.S. Department of Veterans Affairs, Rehabilitation and Prosthetics Services, 810 Vermont Avenue, NW Washington, DC 20420. ‡University of South Florida, Morsani College of Medicine, School of Physical Therapy & Rehabilitation Sciences, 3515 E, Fletcher Avenue, Tampa, FL 33613. Contents of this article are the opinions of the authors and may not represent those of the EACE or the U.S. Department of Veterans Affairs. doi: 10.7205/MILMED-D-16-00262 MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 66
to develop strategies to decrease the risk of loss of bone mineral density. Pregnancy is another consideration for many women with amputations of traumatic etiology that are of reproductive, childbearing age. Pregnancy-related volume change weight gain may cause abnormal wear on components (e.g., pros- thetic feet) that need to be monitored more frequently. Signif- icant
fluid and volume fluctuations of the residual limb are also more common in women particularly during pregnancy, and this can affect the fit of the prosthetic socket. 17 Addition- ally, weight fluctuation may necessitate a category change in selected componentry if, for instance, a component ’s weight limit is exceeded during gestation. Similarly, pregnancy will alter the woman ’s center of mass throughout the pregnancy, which may challenge balance, prosthetic alignment, and risk of falls for the prosthetic user. Appropriate monitoring and intervention should be applied if any of these complications arise; however, prevention of such issues is always the pre- ferred strategy. Transdisciplinary care teams including medical profes- sionals that work with female Veterans with amputations should consider that enhanced levels of communication may be necessary in order to maximize satisfaction and quality of care. Women Veterans may also have a greater need for pri- vacy and security in the clinic setting. Women Veterans with amputations will frequently have different rehabilitation goals, including a greater desire to become independent in household activities and to pursue different recreational and leisure pursuits. 18 Women who have undergone amputation also have different psychological and adjustment issues related to their amputation. 18 –20
Providers caring for this group will be able to optimize health and quality of life if armed with awareness of key differences in gender as well as the latest scienti fic developments. VA INITIATIVES AND STRATEGIES The VA increasingly recognizes the growing population and unique health care needs of women Veterans, including those who have limb amputations. VA implemented the Poly- trauma System of Care and the Amputation System of Care (ASoC) to provide specialized expertise in rehabilitation and amputation care. 21 The ASoC incorporates the latest prac- tices in medical rehabilitation, therapy services, and pros- thetic technology in order to enhance the environment of care and ensure consistency in the delivery of rehabilitation services for all Veterans with amputations. VA clinicians working with Veterans with amputations evaluate each patient individually and develop unique, patient-speci fic treatment plans that consider the Veteran’s gender and other individual characteristics. 22 A transdisci- plinary team including specialized physicians, prosthetists, and rehabilitation therapists utilizing a team-based approach helps to assure that each Veteran ’s short- and long-term goals and health care needs are addressed. To ensure that the psychosocial and emotional needs of the female Veteran with an amputation are met, enhanced supportive services, including peer support mentoring or psychological counsel- ing are provided. 23 Counseling or psychological support for other mental health issues such as post-traumatic stress dis- order (PTSD) or military sexual trauma are also extended as needed. Since implementing the ASoC in 2008, VA has com- pleted and implemented numerous initiatives related to this group: • Convening education and training conferences focused on women
’s health care needs; • Conducting panel discussions with groups of Female Veterans with amputations; • Hosting national conference calls including education for various groups of providers and care managers on the Vet- eran amputee population and speci fic considerations; • Publishing scientific journal articles to educate pro- viders on the unique needs of Female Veterans with amputations; 18,24 and
• Providing online educational training (FY2013) on the unique needs of female Veterans with traumatic extrem- ity injury and amputation. This review has provided an overview of considerations unique to the female Veteran with amputation. These factors should be taken into account if treatment strategies are to be successful and gaps in commercially available products and research are going to be appropriately identi fied. Logical next steps might include rigorously de fining the population of women Veterans with amputation, systematically reviewing the literature regarding what is known about issues facing women Veterans with amputation, and generating associated research priorities. Still, much remains unknown and ongoing clinical and academic discourse on this topic is necessary to continue advancing the science and improving care for this deserving population. REFERENCES 1. Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R: Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil Mar 2008; 89(3): 422 –9. 2. U.S. Department of Veterans Affairs: V.A. Of fice of Inspector General. Healthcare Inspection Prosthetic Limb Care in VA Facilities. (Report no. 11-02138-116). Washington, DC, 2012. Available at http://www.va .gov/oig/pubs/VAOIG-11-02138-116.pdf; accessed July 7, 2016. 3. U.S. Department of Housing and Urban DevelopmentOf fice of Commu- nity Planning and DevelopmentU.S. Department of Veterans Affairs: National Center on Homelessness Among Veterans. Veteran Homeless- ness: A Supplement to the 2010 Annual Homeless Assessment Report to Congress. 2010. Available at http://www.va.gov/HOMELESS/docs/ 2010AHARVeteransReport.pdfm; accessed July 7, 2016. 4. U.S. Department of Labor: Bureau of Labor Statistics. Employment Situation of Veterans Summary (USDL-15-0426). 2014. Available at http://www.bls.gov/news.release/archives/vet_03182015.pdf; accessed July 7, 2016. 5. Singh R, Hunter J, Philip A, Tyson S: Gender differences in amputation outcome. Disabil Rehabil 2008; 30(2): 122 –5.
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 67 A Review of Unique Considerations for Female Veterans With Amputation 6. Abe T, Brechue WF, Fujita S, Brown JB: Gender differences in FFM accumulation and architectural characteristics of muscle. Med Sci Sports Exerc 1998; 30(7): 1066 –70.
7. Hill DW, Smith JC: Gender difference in anaerobic capacity: role of aerobic contribution. Br J Sports Med 1993; 27(1): 45 –8. 8. Kubo K, Kanehisa H, Fukunaga T: Gender differences in the viscoelastic properties of tendon structures. Eur J Appl Physiol 2003; 88(6): 520 –6.
9. Lewis DA, Kamon E, Hodgson JL: Physiological differences between gen- ders. Implications for sports conditioning. Sports Med 1986; 3(5): 357 –69. 10. Pezzin LE, Dillingham TR, Mackenzie EJ, Ephraim P, Rossbach P: Use and satisfaction with prosthetic limb devices and related services. Arch Phys Med Rehabil 2004; 85(5): 723 –9. 11. Biddiss E, Chau T: Upper-limb prosthetics: critical factors in device abandonment. Am J Phys Med Rehabil 2007; 86(12): 977 –87.
12. Hirsh AT, Dillworth TM, Ehde DM, Jensen MP: Sex differences in pain and psychological functioning in persons with limb loss. J Pain 2010; 11(1): 79 –86.
13. Frlan-Vrgoc L, Vrbanic TS, Kraguljac D, Kovacevic M: Functional out- come assessment of lower limb amputees and prosthetic users with a 2-minute walk test. Coll Antropol 2011; 35(4): 1215 –8.
14. Struyf PA, van Heugten CM, Hitters MW, Smeets RJ: The prevalence of osteoarthritis of the intact hip and knee among traumatic leg ampu- tees. Arch Phys Med Rehabil 2009; 90(3): 440 –6.
15. Lim LS, Hoeksema LJ, Sherin K, ACPM Prevention Practice Committee: Screening for osteoporosis in the adult U.S. population: ACPM position statement on preventive practice. Am J Prev Med 2009; 36(4): 366 –75.
16. Smith E, Comiskey C, Carroll A, Ryall N: A study of Bone Mineral Density in Lower Limb Amputees and a National Prosthetics Center. J Prosthet Orthot 2011; 23(1): 14 –20.
17. Sanders JE, Allyn KJ, Harrison DS, Myers TR, Ciol MA, Tsai EC: Pre- liminary investigation of residual-limb fluid volume changes within one day. J Rehabil Res Dev 2012; 49(10): 1467 –8. 18. Elnitsky CA, Latlief GA, Andrews EE, Adams-Koss LB, Phillips SL: Preferences for rehabilitation services among women with major limb amputations. Rehabil Nurs 2013; 38(1): 32 –6. 19. Benetato BB: Posttraumatic growth among operation enduring freedom and operation Iraqi freedom amputees. J Nurs Scholarsh 2011; 43(4): 412
–20. 20. Cater JK: Traumatic amputation: psychosocial adjustment of six Army women to loss of one or more limbs. J Rehabil Res Dev 2012; 49(10): 1443
–56. 21. Webster JB, Poorman CE, Cifu DX: Guest editorial: Department of Veterans Affairs Amputations System of care: 5 years of accomplish- ments and outcomes. J Rehabil Res Dev 2014; 51(4): vii –xvi. 22. VA/DoD Clinical Practice Guideline for Rehabilitation of Lower Limb Amputation: Guideline Summary. U.S. Department of Veterans Affairs Of fices of Quality & Performance and Patient Care Services. U.S. Depart- ment of Defense. 2008. Available at http://www.healthquality.va.gov/ guidelines/Rehab/amp/amp_sum_correction.pdf; accessed July 7, 2016. 23. Webster JB, Poorman CE, Cifu DX. Department of Veterans Affairs amputation system of care: 5 years of accomplishments and outcomes. JRRD 2014; 51(4): vii –xiii. Available at http://www.rehab.research.va .gov/jour/2014/514/pdf/jrrd-2014-01-0024.pdf; accessed July 7, 2016. 24. Highsmith MJ, Kahle JT, Knight M, Olk-Szost A, Boyd M, Miro RM: Delivery of cosmetic covers to persons with transtibial and transfemoral amputations in an outpatient prosthetic practice. Prosthet Orthot Int 2016; 40(3): 343 –9.
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 68 A Review of Unique Considerations for Female Veterans With Amputation MILITARY MEDICINE, 181, 11/12:69, 2016 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis (IDEO): A Systematic Review of the Literature CPT M. Jason Highsmith, SP USAR*†‡; Leif M. Nelson, DPT*†; Neil T. Carbone, CP, BOCO§; Tyler D. Klenow, MSOP∥; Jason T. Kahle, MSMS, CPO, FAAOP‡; LTC Owen T. Hill, SP USA*¶; Jason T. Maikos, PhD§; Mike S. Kartel, CO, BOCP∥; COL Billie J. Randolph, SP USA (Ret.)*† ABSTRACT High-energy lower extremity trauma is a consequence of modern war and it is unclear if limb ampu- tation or limb salvage enables greater recovery. To improve function in the injured extremity, a passive dynamic ankle-foot orthosis, the Intrepid Dynamic Exoskeletal Orthosis (IDEO), was introduced with specialized return to run (RTR) therapy program. Recent research suggests, these interventions may improve function and return to duty rates. This systematic literature review sought to rate available evidence and formulate empirical evidence state- ments (EESs), regarding outcomes associated with IDEO utilization. PubMed, CINAHL, and Google Scholar were systematically searched for pertinent articles. Articles were screened and rated. EESs were formulated based upon data and conclusions from included studies. Twelve studies were identi fied and rated. Subjects (n = 487, 6 females, mean age 29.4 year) were studied following limb trauma and salvage. All included studies had high external valid- ity, whereas internal validity was mixed because of reporting issues. Moderate evidence supported development of four EESs regarding IDEO use with specialized therapy. Following high-energy lower extremity trauma and limb salvage, use of IDEO with RTR therapy can enable return to duty, return to recreation and physical activity, and decrease pain in some high-functioning patients. In higher functioning patients following limb salvage or trauma, IDEO use improved agility, power and speed, compared with no-brace or conventional bracing alternatives. INTRODUCTION The decision to amputate or attempt salvage of injured limbs is a subject of debate. This decision often emerges in the presence of high-energy lower extremity trauma (HELET). 1,2
An increase in HELET cases has resulted from con flicts
related to Operations Iraqi Freedom (OIF), Enduring Free- dom (OEF), and Operation New Dawn (OND) compared to previous con flicts.
3,4 This is because of improvements in body armor and battle field trauma care, as well as changes in warfare style including enemy use of improvised explosive devices (IEDs). 2,5 –7
injury are associated with these con flicts, with 79% of all combat injuries resulting from blast exposure. 2 –4,7 Further, approximately 1,600 amputations have occurred as a result of injuries sustained in these con flicts.
3 Both limb amputation and salvage result in neuromus- culoskeletal de ficit, which can lead to pain and loss of strength, power generation, range of motion, and sensation. These impairments can impact function and quality of life. Outcomes following amputation have been compared to those following limb salvage. 8 A de
finitive advantage to either has not been identi fied. 9
Common goals of many injured service personnel include returning to an active life- style and possibly to active duty. 1 The high incidence of HELET and high functional expectations following rehabili- tation has pressed the U.S. Departments of Defense (DoD) and Veteran ’s Affairs (VA) to create innovative adaptive devices and rehabilitation interventions. One such device is the Intrepid Dynamic Exoskeletal Orthosis (IDEO). This energy storing and return —ankle-foot orthosis was first reported in 2009. 13 The IDEO was designed to address impairments created by HELET, such as dimin- ished plantar flexion and propulsive force, decreased weight acceptance, and compromised joint stabilization. 1,13,14 Addi-
tionally, an integrated rehabilitation program Return to Run (RTR) in concert with prescription of an IDEO has shown promise in enabling military personnel to return to duty (RTD) and reintegrate into an active lifestyles following injury. 1,15
This orthosis also shows potential in managing other military- and combat-related conditions such as primary and traumatic arthritis. 16 Several studies have demonstrated ef ficacy in military service personnel after accommodation and use of the IDEO following HELET. 17 Therefore, the pur- pose of this systematic literature review was to rate the level of evidence and formulate empirical evidence statements (EESs) regarding outcomes associated with IDEO utilization. *Extremity Trauma and Amputation Center of Excellence, 2748 Worth Road, Suite 29, Fort Sam Houston, TX 78234. †U.S. Department of Veterans Affairs, Rehabilitation and Prosthetics Services, 810 Vermont Avenue, NW Washington, DC 20420. ‡University of South Florida, Morsani College of Medicine, School of Physical Therapy & Rehabilitation Sciences, 3515 E, Fletcher Avenue, Tampa, FL 33613. §Veterans Affairs New York Harbor Healthcare System, 423 E, 23rd Street, New York, NY 100105. ∥James A. Haley Veterans Administration Hospital, 13000 Bruce B. Downs Boulevard, Tampa, FL 33612. ¶Headquarters and Headquarters Company, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX 78234. Contents of the manuscript represent the opinions of the authors and not necessarily those of the Department of Defense, Department of Veterans Affairs, or the Department of the Army. doi: 10.7205/MILMED-D-16-00280 MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 69
PICO QUESTION The PICO
18 (population, intervention, comparison, outcome) question guiding the search for evidence for this review was: In patients exposed to high-energy lower extremity trauma and limb salvage (P), what functional outcomes can be expected (O), following use of the IDEO (I) compared to alternatives such as conventional orthoses or amputation (C). METHODS
Search Strategy A search strategy used in several previous prosthetic and amputee systematic reviews was implemented. 19,20
The Medline and CINAHL databases were searched via the Ovid and EBSCO Host interfaces (respectively). Google Scholar was also searched. Searches were conducted on July 1, 2015, and were based on the following terms: — Primary search terms: “ankle-foot orthosis, IDEO or Intrepid Dynamic Exoskeletal Orthosis, military, and limb salvage ” (searched independently and in combi- nation with 1 of the secondary search terms). — Secondary search terms: “AFO, ankle brace, ground reaction, energy storing and return, running orthosis, patella tendon bearing orthosis, posterior strut orthosis, orthoses, orthotic, return to duty, return to run, lower extremity trauma, high activity, veteran, high energy lower extremity trauma, HELET, post-traumatic, lower limb impairment, integrated orthotic, integrated rehabili- tation, integrated orthotic and rehabilitation, carbon fiber, limb reconstruction, and trauma.” Searches were prelimited using the following criteria: English language, abstract available, and peer reviewed (CINAHL and Google Scholar). In Medline, the “map term to subject heading ” feature was deselected to eliminate a medical subject heading (MeSH) term search. In CINAHL, a default Boolean search was used. A publication date of 2003
–2015 was chosen in all databases as the beginning of OIF was in 2003. A manual search of included articles ’ reference lists was also conducted in the event of very recent publications or keywords missed important publications in the automated search. Screening Resulting references were exported to EndNote (vX7, Thompson, California) bibliographic citation software. Two reviewers independently screened resulting references ’ titles, then abstracts, and finally, full-text articles according to inclusion/exclusion criteria (listed below). Articles were then classi fied as either (i) pertinent, (ii) not pertinent, or (iii) uncertain pertinence. Full-text articles were then reviewed for all manuscripts classi fied as pertinent or uncer- tain pertinence. Disagreements regarding citations of uncertain pertinence were resolved by having the 2 reviewers indepen- dently review full-text articles then discussing and agreeing on ultimate inclusion or exclusion. Inclusion Criteria (1) Peer-reviewed publication; (2) Study used objective/quanti fiable outcome measures; (3) IDEO was utilized as an intervention. Exclusion Criteria (1) Endoprosthetic ankle joints (i.e., joint arthroplasty); (2) Editorial, classi fication or taxonomy articles; and (3) Duplicate publication. Study Data Data from each article including demographic, anthropomet- ric, dependent and independent variables, quanti fiable out- comes, and conclusions were entered into an Excel database (Microsoft Corporation, Redmond, Washington). These data were veri fied by a multidisciplinary team (i.e., physical ther- apists, orthotists, epidemiologists, and biomechanists) for completeness and accuracy. Data were assessed for the abil- ity to aggregate for descriptive characteristics (i.e., anthro- pometrics) as well as outcomes (i.e., RTD rate, number of delayed amputations). Effect sizes (Cohen ’s d), were calcu- lated for all articles with available data using formulas based on independent t tests. 21 Controversy exists in the use of this technique compared with a calculation enabling control for data dependency. Effect sizes are commonly larger when data dependency is considered. However, limitations include requiring more information from source studies (i.e., correla- tion and coef ficient between the data under examination). 21 Because the articles reviewed provided limited information, the calculation based on independent groups was selected rec- ognizing that this is a conservative approach. Cohen described effect sizes as small (0.2), medium (0.5), and large (0.8). 21 Quality Assessment The study design and methodological quality of those publi- cations that met eligibility criteria were independently assessed by 2 reviewers according to the American Acad- emy of Orthotists and Prosthetists (AAOP) State-of-the- Science Evidence Report Guideline Protocol. 22 Reviewers discussed pertinent issues until consensus on study design and methodological quality was obtained for the included publications. Each reviewer rated each study according to the AAOP Study Design Classi fication Scale that describes the type of study design. 22 The State of the Science Confer- ence (SSC) Quality Assessment Form 22 was used to rate methodological quality of studies classi fied as experimental (E1 –E5) or observational (O1–O6). The form identifies 18 potential threats to internal validity with the first 4 (E3–E5) or 5 (O1 –O6) criteria not applicable for given study classifi- cations and 8 potential threats to external validity. Threats were evaluated and tabulated. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 70 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis The internal and external validity of each study was then subjectively rated as “high,” “moderate,” or “low” based on the quantity and importance of threats present. As a guide, for internal validity, 0 to 3 threats was rated “high,” 4 to 6 threats as “moderate,” and 7 to 13/14 threats as “low.” For external validity, 0 to 2 threats was rated “high,” 3 to 5 threats as “moderate,” and 6 to 8 threats as “low.” Each study was given an overall quality of evidence of “high,”
“moderate,” and “low” outlined by the AAOP State-of-the- Science Evidence Report Guidelines. 22 The overall ratings from the AAOP State-of-the-Science Evidence Report Guide- lines were used in assigning con fidence to the developed EESs described in the results section. Empirical Evidence Statements Based on results from the included publications, EESs were developed describing ef ficacy of the IDEO. Reviewers rated the level of con fidence of each EES as “high,” “moderate,” “low,” or “insufficient,” based on the number of publications contributing to the statement, the methodological quality of those studies and whether the contributing findings were con firmatory or conflicting. 22 RESULTS
In total, 375 articles were identi fied from the search (Fig. 1). Of these, 12 met inclusion criteria. Publication dates of the 12 included articles ranged from 2011 to 2015 with 6 pub- lished in 2014. Half of the studies were observational and the other half was experimental (Table I). No systematic reviews or meta-analyses were identi fied. Because of heterogeneity in sample size and demography, methods, accommodation periods, outcome measures and design, and meta-analyses were not possible. Manuscripts were published predomi- nantly in orthopedic trauma and biomechanical journals (Table II). Subjects
A total of 487 subjects were studied within all 12 manuscripts (Table III). Only six females were reportedly studied. 14,16 One subgroup of amputees (n = 57) were included. 23 Uninjured, healthy subjects were recruited as controls in two studies to provide reference values of unimpaired gait func- tion in which to compare against. This accounted for 25 sub- jects wherein both articles, reference groups ’ mean age was 23 years, mean height was 1.8 m, and the mean mass was 86 kg
24 and 87 kg 25 respectively. Conversely, control subjects (n = 81), utilized in two other studies had experienced HELET including volumetric muscle loss below the knee, distal motor nerve injury, lower limb fracture, and other inju- ries.
15,23 Of these 81 control subjects, 31 had a mean age of 30 years and received IDEO only as opposed to IDEO and RTR training. 15 The remaining 50 of these subjects received limb salvage and there were no reports of IDEO provision nor anthropometry. 23 Of the total 487 subjects from all included studies, another subgroup of 102 participants served as their own controls in FIGURE 1. Results of the literature search and application. TABLE I.
Distribution of Included by Studies by Study Design Study
Design Publications S1 Meta-Analysis 0 S2 Systematic Review 0 E1 Randomized Control Trial 1 E2 Controlled Trial 2 E3 Interrupted Time Series Trial 1 E4 Single Subject Trial 0 E5 Controlled Before and After Trial 2 O1 Cohort Study 2 O2 Case –Control Study 0 O3 Cross-Sectional Study 2 O4 Qualitative Study 1 O5 Case Series 0 O6 Case Study 1 X1 Group Consensus 0 X1 Expert Opinion 0 Total 12 TABLE II. Distribution of the Studies per Journal Journal
Number of Publications Clinical Biomechanics 1 Clinical Orthopaedics and Related Research 2 Gait and Posture 1 Journal of Biomechanical Engineering 1 Journal of Bone and Joint Surgery 1 Journal of Orthopaedic Trauma 2 Journal of Surgical Orthopaedic Advances 1 Journal of the American Academy of Orthopaedic Surgeons 1 Journal of Trauma and Acute Care Surgery 1 Journal of Trauma, Injury, Infection and Critical Care 1 Total
12 MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 71 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis repeated measure design protocols. They first completed preorthotic physical therapy. One group (n = 84) underwent baseline assessment then received IDEO plus additional ther- apy followed by post-assessment. 14 This group included 5 females and was described in the manuscript better from an injury perspective than from a demographic perspective. The remaining 18 randomized for repeated assessment with three different orthoses including IDEO. 26 Finally, a total of 253 of the 487 subjects were studied as experimental subjects. Eleven of the 12 studies reported age, and
five5 24 –28 reported subject height and mass or body mass index (BMI). Interquartile mean (range) for studies reporting anthropometric data yields an age of 29.4 (1.7) years, height of 1.8(0.02) m, and mass of 87.8(1.9) kg. Mean BMI was 28.5 kg/m 2 reportedly. 23 Diagnoses for subjects in the experi- mental groups of studies included; open ankle fracture, knee, or ankle ligamentous damage or instability; bone, muscle, or other tissue loss; post-traumatic osteoarthritis; fractures of the spine and upper extremity; burns; hip subluxation; lower extremity motor nerve injury; ankle muscle weakness; neu- ropathy; paresis; equinovarus; shrapnel presence; vascular injury; ankle arthrodesis; reconstruction of the foot or ankle and soft tissue trauma. Additionally, subjects with spinal cord injury were provided IDEOs and physically assessed. 14,15
The mechanism of injury for these diagnoses tended to include HELET and more speci fically causes such as motor vehicle accidents, blast injuries, gunshot wounds, and falls. Delayed Amputation and RTD Seventy three patients initially requested amputation. Of these, 13 continued to request or received an amputation fol- lowing provision of an IDEO and RTR training. Among these, there were no reports of RTD. 14,16,17,26 Conversely, one study 23 reported that of 57 patients who received amputa- tion, 7 (12.3%) RTD. Of 325 patients that received limb sal- vage, 108(33.2%) returned to duty. Within these 325 cases, one subset of 275 (84.6%) received an IDEO and a second subset of 244 (75.1%) reportedly received an IDEO in combi- nation with RTR therapy. From the first subset, 96 (34.9%) returned to active duty, whereas 92 (37.7%) from the second subset returned to active duty. 1,13,15 –17,23
Internal Validity The most prevalent threats to internal validity in this body of literature include a lack of blinding, a lack of reporting exclusion criteria, no reported consideration for fatigue and learning, and no reporting of effect size (Table IV). The overall assessment was blended with 5/12 of the studies being rated as having low internal validity, 5/10 having moderate-level internal validity, and 2/10 having high inter- nal validity. Additionally, two studies had attrition greater than 20% (22 –38%). 14,15
External Validity All 12 studies had high external validity. The most common threat to external validity across studies was a lack of describ- ing the sample adequately. For instance, 7 of 12 studies did not adequately describe the sample in terms of anthropometry and demography. Effect Size Effect sizes were unable to be calculated in several of the included studies. Five studies utilized either case report methodology or descriptive outcomes, which are not condu- cive to these calculations. 1,13,15
–17 Additionally, Harper et al TABLE III. Characteristics of Included Studies Author (Year) Study Design Independent Variable(s) Sample
Size Mean
Age* Outcome Measures Overall Quality of Evidence Patzkowski et al (2011) O6 IDEO + RTR 1 29 Return to Recreation and Duty Moderate Owens et al (2011) O4 IDEO + RTR 10 28.8
Return to Recreation and Duty Moderate
Patzkowski et al (2012) O3 IDEO + RTR 16 28 Return to Function, Recreation and Dutyd Moderate
Patzkowski et al (2012) O3 IDEO + RTR 17 31.4
RTD + Clinical Endpoints Moderate
Patzkowski et al (2012) E1 IDEO + RTR vs. Other Orthoses 18 31 Clinical Functional Performance Outcome Measures Moderate
Harper et al (2014) E5 IDEO Strut Stiffness 13 29.4
LE Biomechanical Analyses High
Blair et al (2014) O1 IDEO + RTR 146 31.5
Return to Duty Moderate
Bedigrew et al (2014) E2 IDEO + RTR. Early vs. Late Rehab Entry 84 NR † Functional Performance Outcomes and Perceptive Measures Moderate Esposito et al (2014) E3 IDEO Strut Stiffness 26 29.4
LE Biomechanical Analyses Moderate
Harper et al (2014) E5 IDEO Strut Construction 10 28.7
LE Biomechanical Analyses High
Sheean et al (2014) O1 Hindfoot Reconstruction (w/IDEO + RTR) vs. Amputation 122 26
and Duty Moderate
Haight et al (2015) E2 IDEO Strut Stiffness 24 29.3
LE Biomechanical Analyses Moderate
IDEO, (Intrepid Dynamic Exoskeletal Orthosis; LE, Lower Extremity; NR, Not Reported; RTR, Return to Run. *Experimental subjects and age in years. †Eligibility was aged >18 year. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 72 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis chose a graphic representation of spatiotemporal and bio- mechanical differences between carbon fiber and nominal stiffness IDEO braces. 28 This is an acceptable method for presenting measures of central tendency and variance and even preferred at times to depict continuous phenomena. However, this form of data presentation is also not condu- cive to the calculation of magnitude of effect. Bedigrew et al compared differences in physical perfor- mance and perceptive measures at 3 assessment points; immedi- ately postinjury, post physical therapy before bracing and again following bracing with additional physical therapy. 14 This
group reported effect size (calculated as a difference in means) in all study measures. Effect sizes for differences in physical performance measures immediately postinjury compared to post bracing and therapy were considerable, ranging from 24 to 166% improvements. Effect sizes for pain scores were generally improved (i.e., reduced pain) following bracing and therapy by a magnitude of 23 to 35%. Patients entering into rehabilitation late experienced reduced magnitude of effect to 16 to 45% for physical performance and 27 to 38% for perceptive measures. Although these outcomes were of a relatively reduced effect compared to their early-entry peers, these were still statistically signi
ficant ( p ≤ 0.05) as well as clinically important. In total, 82 comparisons were eligible for effect size anal- ysis per this review ’s protocol. Of these, 64 involved use of an IDEO. More speci fically, IDEO was compared relative to either a comparator (or no brace) or IDEO con figuration (i.e., strut stiffness) was modi fied and compared. Within the subset of IDEO involved comparisons, 37.5% were of a large magnitude of effect, 25% were of medium magnitude, and the remaining 37.5% were of a small effect size. For instance, Haight et al studied differences in IDEO strut stiffness between sound and involved limbs and to unimpaired control limbs. 24 Effect size (Cohen ’s d ) was 0.03 (small) regarding peak knee extension moment between control and experimental subjects ’ involved limb while using a compres- sive IDEO brace. Oppositely, effect size was 5.9 (large) when comparing the differences in ankle range of motion between sound and involved sides when a stiff IDEO brace was utilized. Esposito et al identi fied 5 statistically significant kine- matic comparisons. 25 Of these, comparisons between com- pliant and more rigid IDEO strut designs were larger than those comparing nominal with stiff strut designs. Speci fi- cally, 3/3 kinematic comparisons were of medium effect size when comparing compliant with nominal and stiff IDEO struts, whereas 2/2 signi ficant comparisons between nominal and stiff strut designs resulted in small effects. During functional performance tasks, IDEO use resulted in large effects in self-selected walking velocity regardless of comparator and again had large effects on speed over uneven terrain and the 40-yd dash compared to a Blue Rocker orthosis (Allard USA, Rockaway, New Jersey). Medium effects were observed during stair climbing and in the four-square step test when IDEO was used in compari- son with the Blue Rocker and a no brace condition. 26 When
non-IDEO braces or no brace was used all signi ficant com- parisons were of a small magnitude of effect. Conversely, when IDEO was used during these tasks, 25% of signi ficant comparisons were of a medium or large magnitude of effect. Empirical Evidence Statements The following four evidence statements were formulated and supported by moderate-level evidence: (1) In service personnel under 40 years of age, injured with high-energy lower extremity trauma, potentially confounded by post-traumatic ankle osteoarthritis, fitting, and use of IDEO with RTR physical therapy following limb salvage surgery may allow return to active duty for a limited population of high- functioning patients. 1,13,15 –17,23
(2) In service personnel under 40 years of age, injured with high-energy lower extremity trauma, potentially confounded by post-traumatic ankle osteoarthritis, TABLE IV. Internal and External Validity of Included Studies Author (Year) Study Design
Internal Validity External Validity 1 2
4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Total 1 2 3 4 5 6 7 8 Total Patzkowski (2011) O6 n/a n/a n/a n/a n/a • • • • Low • • • • • • • High Owens (2011) O4 n/a n/a n/a n/a n/a • • • • • Low
• • • • • • • High Patzkowski (2012) O3 n/a n/a n/a n/a n/a • • • • • • Low
• • • • • • • High Patzkowski (2012) O3 n/a n/a n/a n/a n/a • • • • • • • • Low • • • • • • • High Patzkowski (2012) E1 • • • n/a
• • • • • • • • • Moderate • • • • • • • • High Harper (2014) E5 n/a n/a n/a n/a • • • • • • • • • • • High • • • • • • • • High Blair (2014) O1 n/a n/a n/a n/a n/a • • • • • • • Moderate • • • • • • • High Esposito (2014) E2 •
• • •
• • • • • • • Moderate • • • • • • • • High Bedigrew (2014) E3 n/a n/a n/a n/a • • • • • • • • • • Moderate • • • • • • • High Harper (2014) E5 n/a n/a n/a n/a • • • • • • • • • • • High • • • • • • • • High Sheean (2014) O1 n/a n/a n/a n/a n/a • • • • • • • • Moderate • • • • • • • High Haight (2015) E2 •
• • • • • • • • Low
• • • • • • • • High “n/a” indicates this particular criteria is not applicable for the given study design. The symbol “•” indicates that the criteria was satisfied. A blank space (no symbol) indicates that the particular criteria was not satis fied.
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 73 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis fitting, and use of IDEO with RTR physical therapy following limb salvage surgery may allow return to exercise, recreation and physical activity, and decreased pain for a limited population of high- functioning patients. 1,13,14,16,17,26 (3) In service personnel under 40 years of age, injured with high-energy lower extremity trauma, fitting, and use of IDEO with RTR physical therapy following limb salvage surgery, results in improved agility, power, and speed, compared with no-brace or conven- tional bracing alternatives. 26 (4) IDEO strut stiffness should be considered with respect to patient preference. 24,27
–29 Evidence statements 1 and 2 are each supported by six moderate-quality studies. Evidence statement 3 is supported by a single moderate-quality study and statement 4 is supported by two high-quality studies and two moderate- quality studies. These combinations of evidentiary support provide a “moderate” level of confidence for each of the four EESs. DISCUSSION With regard to study design, half of included studies were observational and half experimental. Although this is a rea- sonable blend of study designs, an optimal body of literature would enable meta-analysis from more prospective, random- ized control trials. Internal validity could have been strength- ened in these studies with minor reporting changes in accordance with standardized criteria. 30,31
For instance, had the included samples been better described (i.e., more uni- form reporting of anthropometry and demography), effect sizes been reported and learning/accommodation and fatigue reported, more of the studies would have likely improved their internal validity ratings from “low” to “moderate” or “moderate” to “high.” Conversely, external validity was uni- formly high which provides con fidence that results have clinical importance but may be biased from a methodologic perspective (i.e., internal validity). Selection and reporting bias could contribute to favorable results in the included articles. Epidemiologic studies including larger samples could clarify the potential for larger generalizability to clini- cal practice. Another strength of the included studies is that a blend of outcome measures supports the evidence statements and conclusions from these studies. Perceptive, functional perfor- mance, biomechanical, RTD, and delayed amputation out- comes have been studied. Although this is a strength and provides the ability to determine how the IDEO and RTR program may effect patients like those studied, it is unlikely that some of the outcomes selected would be valuable to others who may be able to utilize these interventions. For instance, older Veterans and civilians will not have compa- rable endpoints such as RTD. Many others such as bio- mechanical, functional, and perceptive measures will likely translate across populations. The fact that the majority of the effect sizes were medium and large when IDEO and RTR therapy were provided suggests that the outcome measures selected were responsive to change and that these interven- tions had clinical signi ficance in the studied populations. As anticipated, all of the subjects studied were young ( ≤30-year mean) in accordance with a military population. With the exception of subjects diagnosed with post-traumatic osteoarthritis, 16 the majority were recently injured with acute HELET. A small number of female patients and some with spinal cord injury were included. However, there was insuf fi- cient representation to determine ef ficacy of IDEO and RTR in either of the latter groups. Further, the performance results described herein are largely attributed to IDEO and RTR (independent variables). However, it must be considered that a factor contributing to the effects observed include the prior
fitness level and age of the subjects. It could be that the magnitude of effect would not be as large in patients who are older, have increased BMI and have lower levels of fitness. Moreover, the confounding effects of post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI) as it relates to prescription, utilization, and ef ficacy of IDEO and RTR remain unknown. As patients such as those studied begin to separate from military service and enroll for bene fits
with the Veterans Health Administration, it is unclear the extent to which these results will generalize to a larger Vet- eran population. Approximately 3% of studied subjects requested or received an amputation despite provision of IDEO and RTR. None of this group returned to duty and the factors preventing their potential return were not reported. 14,16,17,26 Oppositely, approximately 12% of patients who went directly to amputa- tion, did RTD. 23 It is unclear what differentiated the clinical decisions that lead each group to their respective endpoints. However, it is important to understand through future study, why limb salvage coupled with IDEO and RTR were not as successful in these cases. This further emphasizes the value of individual evaluations at the present time to determine the best clinical path for the individual patient. Approximately 33% of patients who received limb salvage, returned to duty. From these, approximately 80% received IDEO and RTR and approximately a third, returned to active duty. 1,13,15
–17,23 A signi ficant barrier in understanding this patient demographic and the associated clinical pathways they will follow, is the lack of an agreed upon de finition for “limb-salvage” cases. Having such a de finition would clarify which injuries are determined to be “salvageable” and what are the associated functional prognoses. Major
findings of this review include the EESs supported by moderate evidence suggesting that following HELET it is reasonable for a limited, homogeneous population within the military community, to be able to RTD. 1,13,15 –17,23
Given the high costs and time associated with training for military service, this has obvious financial implications. Further, pos- itive outcomes associated with post-traumatic interventions MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 74 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis such as IDEO and RTR may provide assurance with a deci- sion to serve as opposed to a scenario where functional prognoses following HELET are only poor. Although the clinical endpoint of RTD is not applicable within the Veteran and civilian communities, return to high levels of function and recreation are. 1,13,15 –17,23
Accidents resulting in lower limb trauma are prevalent outside of the military com- munity accounting for nearly 250,000 hospitalizations per year in the private sector. 32 Therefore, adoption of IDEO and RTR interventions may likely have high clinical trans- lation into the Veteran and private sectors. Under ideal cir- cumstances, moderate evidence supports a return to high levels of function and recreation and decreased pain in accor- dance with these interventions. 1,13,14,16,17 Another salient finding is that IDEO outperformed the Blue Rocker and Posterior Leaf Spring designs in functional tasks requiring multidirectional stepping, walking, and run- ning on flat and uneven ground and stair climbing. Perfor- mance was also greater with IDEO than with a no brace condition. Con fidence in this statement is also supported by moderate-level evidence. It is helpful to have comparative outcomes assessments to assist with clinical prescription of a device to maximize function with consideration for a certain patient demographic. Unfortunately, this body of literature only had a single comparative ef ficacy study. 26 With regard to perceptive measures, moderate-level evi- dence also supports that IDEO strut stiffness was more of a factor with regard to patient preference than for gait qual- ity. 24,25,27,28 Finally, pain is a concomitant issue following limb trauma. Use of IDEO was associated with decreased levels of pain. 14 Moderate-level evidence supports both of these effects associated with use of the IDEO. Included liter- ature did not contain reports of safety incidents (i.e., break- age) or adverse events in association with use of the IDEO or RTR therapy and the only contraindication reported related to IDEO use was a knee range of motion of less than 90°.
13 The speci fic design elements of the IDEO that led to the reported outcomes were not clearly delineated. There- fore, it is unclear if design and construction differences will yield the same results. For instance, two speci fic IDEO designs are described: a modular rehabilitation device and a de finitive device. 13 However, performance differences between these are not reported. LIMITATIONS This body of literature only included two studies with high methodologic quality and one comparative ef ficacy study of multiple interventions. Additionally, the subjects studied were homogeneous. Therefore, generalizability beyond young, traumatically injured males is questionable. Methodologic qual- ity could also be improved with standardized reporting. 30,31
Examples include more thorough sample descriptions and effect sizes. Additionally, incorporating blinding (i.e. raters, statisticians) would also improve internal validity. CONCLUSIONS The IDEO was introduced to increase function and return to duty rates following lower extremity trauma and limb salvage. A return to run clinical rehabilitation pathway routinely accompanied the device. Twelve studies provide moderate evidence to support four empirical evidence state- ments. Brie fly, following lower extremity trauma and limb salvage, use of IDEO with RTR therapy can enable return to duty, return to recreation and physical activity and decrease pain in some high functioning patients. Further, in higher functioning patients, the IDEO improved agility, power and speed, compared with no-brace or conventional non-custom bracing alternatives. REFERENCES 1. Owens JG, Blair JA, Patzkowski JC, Blanck RV, Hsu JR, Skeletal Trauma Research C: Return to running and sports participation after limb salvage. J Trauma 2011; 71(Suppl 1): S120 –4.
2. Owens BD, Kragh JF, Jr., Macaitis J, Svoboda SJ, Wenke JC: Charac- terization of extremity wounds in Operation Iraqi Freedom and Opera- tion Enduring Freedom. J Orthop Trauma 2007; 21(4): 254 –7.
3. Krueger CA, Wenke JC, Ficke JR: Ten years at war: comprehensive anal- ysis of amputation trends. J Trauma Acute Care Surg 2012; 73(6 Suppl 5): S438 –44.
4. Stansbury LG, Lalliss SJ, Branstetter JG, Bagg MR, Holcomb JB: Amputations in U.S. military personnel in the current con flicts in Afghanistan and Iraq. J Orthop Trauma 2008; 22(1): 43 –6. 5. Casey K, Demers P, Deben S, Nelles ME, Weiss JS: Outcomes after long- term follow-up of combat-related extremity injuries in a multidisciplinary limb salvage clinic. Ann Vasc Surg 2015; 29(3): 496 –501. 6. Wallace D: Trends in traumatic limb amputation in allied forces in Iraq and Afghanistan. J Mil Vet Health 2015; 20(2). 7. Belmont PJ, Schoenfeld AJ, Goodman G: Epidemiology of combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom: orthopaedic burden of disease. J Surg Orthop Adv 2010; 19(1): 2 –7. 8. MacKenzie EJ, Bosse MJ, Pollak AN, et al: Long-term persistence of disability following severe lower-limb trauma. Results of a seven-year follow-up. J Bone Joint Surg Am 2005; 87(8): 1801 –9. 9. Bosse MJ, MacKenzie EJ, Kellam JF, et al: An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med 2002; 347(24): 1924 –31. 10. Andersen RC, Swiontkowski MF: Moderators ’ summary: perceived per- formance differences. Limb salvage versus amputation in the lower extremity (session II). J Am Acad Orthop Surg 2011; 19(Suppl 1): S20
–22. 11. Doukas WC, Hayda RA, Frisch HM, et al: The Military Extremity Trauma Amputation/Limb Salvage (METALS) study: outcomes of amputation versus limb salvage following major lower-extremity trauma. J Bone Joint Surg Am 2013; 95(2): 138 –45.
12. Busse JW, Jacobs CL, Swiontkowski MF, Bosse MJ, Bhandari M, Evidence-Based Orthopaedic Trauma Working Group: complex limb sal- vage or early amputation for severe lower-limb injury: a meta-analysis of observational studies. J Orthop Trauma 2007; 21(1): 70 –6. 13. Patzkowski JC, Blanck RV, Owens JG, Wilken JM, Blair JA, Hsu JR: Can an ankle-foot orthosis change hearts and minds? J Surg Orthop Adv 2011; 20(1): 8 –18. 14. Bedigrew KM, Patzkowski JC, Wilken JM, et al: Can an integrated orthotic and rehabilitation program decrease pain and improve function after lower extremity trauma? Clin Orthop Relat Res 2014; 472(10): 3017 –5.
MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 75 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis 15. Blair JA, Patzkowski JC, Blanck RV, Owens JG, Hsu JR, Skeletal Trauma Research Consortium (STReC): Return to duty after integrated orthotic and rehabilitation initiative. J Orthop Trauma 2014; 28(4): e70 –4.
16. Patzkowski JC, Owens JG, Blanck RV, Kirk KL, Hsu JR, Skeletal Trauma Research Consortium: Management of posttraumatic osteo- arthritis with an integrated orthotic and rehabilitation initiative. J Am Acad Orthop Surg 2012; 20(Suppl 1): S48 –53. 17. Patzkowski JC, Owens JG, Blanck RV, Kirk KL, Hsu JR, Skeletal Trauma Research Consortium (STReC): Deployment after limb salvage for high-energy lower-extremity trauma. J Trauma Acute Care Surg 2012; 73(2 Suppl 1): S112 –5.
18. Richardson WS, Wilson MC, Nishikawa J, Hayward RS: The well-built clinical question: a key to evidence-based decisions. ACP J Club 1995; 123(3): A12 –13.
19. Highsmith MJ, Kahle JT, Bongiorni DR, Sutton BS, Groer S, Kaufman KR: Safety, energy ef ficiency, and cost efficacy of the C-Leg for trans- femoral amputees: a review of the literature. Prosthet Orthot Int 2010; 34(4): 362 –7.
20. Kahle JT, Orriola JJ, Johnston W, Highsmith MJ: The effects of vac- uum-sssisted suspension on residual limb physiology, wound healing and function: a systematic review. Technol Innov 2014; 15: 333 –1.
21. Cohen J (editor): Statistical Power Analysis for the Behavioral Sciences, Ed 2. Hillsdale, NJ, Erlbaum, 1988. 22. State of the Science Evidence Report Guidelines: American Academy of Orthotists & Prosthetists. Washington DC, 2008. Available at http:// www.oandp.org/grants/MasterAgenda/AAOPEvidenceReportGuidelines .pdf; accessed November 15, 2015. 23. Sheean AJ, Krueger CA, Hsu JR: Return to duty and disability after combat-related hindfoot injury. J Orthop Trauma 2014; 28(11): e258 –2. 24. Haight DJ, Russell Esposito E, Wilken JM: Biomechanics of uphill walking using custom ankle-foot orthoses of three different stiffnesses. Gait Posture 2015; 41(3): 750 –6. 25. Russell Esposito E, Blanck RV, Harper NG, Hsu JR, Wilken JM: How does ankle-foot orthosis stiffness affect gait in patients with lower limb salvage? Clin Orthop Relat Res 2014; 472(10): 3026 –5. 26. Patzkowski JC, Blanck RV, Owens JG, et al: Comparative effect of orthosis design on functional performance. J Bone Joint Surg Am 2012; 94(6): 507 –15. 27. Harper NG, Esposito ER, Wilken JM, Neptune RR: The in fluence of ankle- foot orthosis stiffness on walking performance in individuals with lower- limb impairments. Clin Biomech (Bristol, Avon) 2014; 29(8): 877 –84.
28. Harper NG, Russell EM, Wilken JM, Neptune RR: Selective laser sintered versus carbon fiber passive-dynamic ankle-foot orthoses: a comparison of patient walking performance. J Biomech Eng 2014; 136(9): 091001. 29. Esposito ER, Rodriguez KM, Rabago CA, Wilken JM: Does unilateral transtibial amputation lead to greater metabolic demand during walk- ing? J Rehabil Res Dev 2014; 51(8): 1287 –96.
30. Liberati A, Altman DG, Tetzlaff J, et al: The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evalu- ate healthcare interventions: explanation and elaboration. BMJ 2009; 339: b2700. 31. Moher D, Liberati A, Tetzlaff J, Altman DG: Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009; 339: b2535. 32. MacKenzie EJ, Bosse MJ: Factors in fluencing outcome following limb- threatening lower limb trauma: lessons learned from the lower extremity assessment project (LEAP). J Am Acad Orthop Surg 2006; 14(10 Spec No.): S205 –10. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 76 Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis MILITARY MEDICINE, 181, 11/12:77, 2016 Descriptive Characteristics and Amputation Rates With Use of Intrepid Dynamic Exoskeleton Orthosis LTC Owen Hill, SP USA*†; Lakmini Bulathsinhala, MPH*†; Susan L. Eskridge, PT, PhD†‡; Kimberly Quinn, MSN, RN-BC†‡; MAJ Daniel J. Stinner, MC USA*† ABSTRACT Advancements in ankle-foot orthotic devices, such as the Intrepid Dynamic Exoskeletal Orthosis (IDEO), are designed to improve function and reduce pain of the injured lower extremity. There is a paucity of research detailing the demographics, injury patterns and amputation outcomes of patients who have been prescribed an IDEO. The purpose of this study was to describe the demographics, presenting diagnosis and patterns of amputation in patients prescribed an IDEO at the Center for the Intrepid (CFI). The study population was comprised of 624 service members who were treated at the CFI and prescribed an IDEO between 2009 and 2014. Data were extracted from the Expeditionary Medical Encounter Database, Defense Manpower Data Center, Military Health System Data Repository, and CFI patient records for demographic and injury information as well as an amputation outcome. The most common injury category that received an IDEO prescription was injuries at or surrounding the ankle joint (25.0%), followed by tibia injuries (17.5%) and nerve injuries below the knee (16.4%). Over 80% of the sample avoided amputation within a one year time period using this treatment modality. Future studies should longitudinally track IDEO users for a lon- ger term to determine the long term viability of the device. INTRODUCTION Improvement in U.S. military combat casualty care, coupled with advances in surgical techniques and improved body armor, has led to an increase in battle field injury survival. 1 The
“wounded-to-killed ratio,” which compares the number of wounded in action to the number who perished, currently stands at 7.4:1 for Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF). 2 Service members injured in these current con flicts have a survival rate that is higher than those injured in previous con flicts.
3 This increase in survival has led to a substantial increase in the number of service members who now struggle with long-term disability. In addition to battle inju- ries, service members experience nonbattle injuries because of training activities, physical fitness training, as well as off-duty accidents which can result in long-term disability. 4 Severe lower extremity injuries (LEI) make up the preponder- ance of combat-related injuries seen in service members injured within the OIF and OEF theatre of operations. 5,6 Data gleaned from the Joint Theatre Trauma Registry showed that severe LEI make up 65% of all injuries in both OIF and OEF theatre and 26% of these injuries involve a fracture, with over two thirds complicated by concomitant open wounds. 1 Not surprisingly, given the severity of many of these injuries, 10 to 15% of com- bat-related amputations occur after attempts at limb reconstruc- tion and are considered late amputations, de fined as occurring more than 90 days following the injury. 1,7
In a review of severe open tibia fractures (G&A type III) sustained in combat, 16.9% underwent early amputation whereas 5.2% underwent late ampu- tation.
8 Those that went on to late amputation were more likely to require free or rotational flaps, had higher rates of deep soft tissue infection or osteomyelitis, and underwent more reoperations, all of which highlight the severity of these injuries and complicated post-limb reconstruction clinical course. 9 Noncombat injuries can also result in severe and complex extremity injuries. When considering the impact of noncombat injuries, Hauret et al 3 reported that in 2009, injuries of the lower extremity made up 35% of all noncombat injury problems among military personnel; the most of any anatomical region. These overuse injuries were found to have a huge impact on mission readiness and deployment eligibility. The insurgence of LEI and resulting disabled service members (from both bat- tle and nonbattle environments) have brought attention to the need for improving the rehabilitative care in the Department of Defense. The Center for the Intrepid (CFI), along with two other Department of Defense Advanced Rehabilitation Centers, strives to recuperate injured Soldiers back to duty or civilian life. An *Center for the Intrepid, Department of Rehabilitation Medicine, Brooke Army Medical Center, 3551 Roger Brooke Drive, Joint Base San Antonio, Fort Sam Houston, TX 78234. †Extremity Trauma and Amputation Center of Excellence, 2748 Worth Road, Suite 29, JBSA Fort Sam Houston, TX 78234-6005. ‡Department of Medical Modeling and Simulation, Naval Health Research Center, Ryne Road, #329, San Diego, CA 92152. We are military service members (or employees of the U.S. Government). This work was prepared as part of our of ficial duties. Title 17, U.S.C. §105 provides the copyright protection under this title is not available for any work of the U.S. Government. Title 17, U.S.C. §101 de fines a U.S. Government work as work prepared by a military service member or employee of the U.S. Government as part of those persons of ficial duties. This study was supported by work unit 60808. The views expressed in this article are those of the authors and do not necessarily re flect the official policy or position of the Department of the Navy, Department of the Army, Department of the Air Force, Department of Veterans Affairs, Department of Defense, or the U.S. Government. Approved for public release; distribution unlimited. Human subjects participated in this study after giving their free and informed consent. This research has been conducted in compliance with all applicable federal regulations governing the protection of human subjects in research (Protocol NHRC.2003.0025). doi: 10.7205/MILMED-D-16-00281 MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 77
advanced ankle-foot orthotic (AFO) device, the Intrepid Dynamic Exoskeletal Orthosis (IDEO), was developed at the CFI. The IDEO offers an alternative treatment modality to con- ventional AFOs and increases function of the injured limb allowing patients to achieve relatively high levels of mobility while simultaneously reducing pain levels. 10 When compared to traditional, commercially available AFOs to include the posterior leaf spring and Blue Rocker (Allard, Rockaway, New Jersey), patients performed signi ficantly better in all validated physical performances measures when using the IDEO. The IDEO has been shown to improve the functional capabilities of the LEI population when accompanied with a comprehensive return to run (RTR) clinical pathway. 11 For instance, a cohort of patients prescribed an IDEO were found to have improved outcomes in the domains of running, cycling, and self-reported decreased amounts of pain. 10,11
The combination of the IDEO and RTR pathway has been shown to change a patient ’s decision to amputate and instead continue with their salvaged limb using the IDEO. 12 Although the bene fits of the IDEO device have been charac- terized in the fields of biomechanics and recreational activ- ity
11,13 , there is a paucity of research detailing the descriptive characteristics and injury patterns of the patients who have been prescribed an IDEO. Moreover, little information exists quanti- fying the percentage of patients that have undergone amputation after being prescribed an IDEO and completing the RTR pro- gram. Therefore, the purpose of this descriptive epidemiologic study was to comprehensively detail demographic and occupa- tional characteristics of those who use an IDEO, categorize the presenting injury, and quantify the proportion of patients who underwent amputation after IDEO prescription. The overarching study aims were to: (1) comprehensively describe the demo- graphic and service characteristics of the CFI patient population who used an IDEO and (2) identify IDEO prescription patterns and rates of amputation. This research was the first step in cre- ating an injury pro file of patients who will benefit most from an IDEO and the subsequent rehabilitation. Creating such an injury pro file will provide clinicians information on which patients can bene fit the most from the IDEO and the RTR training program. MATERIALS AND METHODS The population under study included all injured service mem- bers who were treated at the CFI during the period 2009 –2014.
Data were extracted from the Expeditionary Medical Encounter Database (EMED), Defense Manpower Data Center (DMDC), Military Health System Data Repository (MDR), and the CFI patient records. An analytic dataset was constructed with vari- ables representing the most current status on demographic and military characteristics. Injured service members who were pre- scribed an IDEO at the CFI were identi fied and corresponding administrative and medical records were merged to form the final
analytical dataset. The demographic descriptions were: sex (M/F), age (<20, 20 –25, 26–30, and >30 years), race (White, Black, Asian, American Indian/Alaskan Native, Hawaiian/Other Paci fic Islander, and Other), and marital status (married, divorced/ single/separated). Military characteristics were: service (Army, Marines, Air Force, and Navy/Coast Guard/NOAA) and length of service (1 –5, 6–10, 11–20, and 20+ years). Data elements such as initial referral diagnosis and date of first visit were collected at CFI from February 2009 to Novem- ber 2014 for all patients who were referred for an IDEO. Initial referral diagnosis was the primary diagnosis that was the cause of the IDEO referral to the CFI. Because of the absence of a systematic method to record the referral diagnoses, this informa- tion was collected in a disparate manner. To categorize these data, subject-matter experts (a fellowship-trained orthopedic trauma surgeon and a senior rehabilitative clinician) assigned the primary referral diagnoses into seven injury types: (1) nerve injury below knee; (2) tibia (excluding pilon fracture); (3) ankle ([pilon fracture, ankle post-traumatic osteoarthritis [PTOA], and ankle fusion); (4) hindfoot (hindfoot PTOA, fusion); (5) midfoot/ forefoot; (6) soft tissue (compartment syndrome, Achilles tendon injury, and quadriceps injuries); and (7) other. For data quality assurance, a random 10% of referral diagnoses were compared with the electronic military medical record system by a quali- fied clinician. An amputation of the lower extremity was identi fied if one of the diagnosis codes (see Appendix A) or procedure codes (see Appendix B) was found after at least 22 days from the date of initial evaluation. Procedure codes for fitting a prosthesis were taken into consideration only when found in consortium with an ICD-9 (International Classi fication of Diseases, 9th TABLE I.
Demographic Characteristics and Amputation Status of Service Members Prescribed IDEO (N = 624), 2009 –2014 Demographic Characteristic Total
a N = 624,
n (%) Amputation a N = 121,
n (%) Sex
Male 573 (91.8) 120 (99.2) Female
28 (4.5) 1 (<1)
Age (Years) <20 5 (<1)
2 (1.6) 20 –25 121 (19.4) 31 (25.6) 26 –30
119 (19.1) 23 (19.0) >30 313 (50.2) 52 (43.0) Race
White 439 (70.3) 94 (77.7) Black
64 (10.2) 10 (8.3)
Asian 32 (5.1)
7 (5.8) American Indian/ Alaskan Native 4 (<1)
2 (1.6) Hawaiian/Other Paci fic Islander 4 (<1) 2 (1.6)
Marital Status Married
414 (66.3) 89 (73.5) Divorced/Separated/ Single
178 (28.5) 32 (26.4) Service Army
423 (67.8) 80 (66.1) Marines 97 (15.5) 32 (26.4) Air Force 46 (7.4) 5 (4.1)
Navy/Coast Guard/ NOAA
37 (5.9) 4 (3.3)
Length of Service (Years)
1 –5 95 (15.2) 21 (17.3) 6 –10 171 (27.4) 46 (38.0) 11 –20
169 (27.1) 34 (28.1) >20 94 (15.1) 11 (9.1) a Subject numbers for each variable do not add to total sample due to miss- ing data. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 78 Descriptive Characteristics and Amputation Rates With Use of IDEO Revision, Clinical Modi fication) or procedure code for a lower extremity amputation. RESULTS
The study population comprised 624 service members who were treated at the CFI and prescribed an IDEO between 2009 and 2014. The demographics of the population are documented in Table I. The majority of the service members were equally divided above and below 30 years of age (50.2%), male (91.8%), married (66.3%), and white (70.3%). In comparison with the overall Armed Services, 2 this sample is slightly older, more likely to be male and married but similar in race/ethnicity. The study cohort predominately consisted of Army (67.8%) ser- vice members, followed by the Marine Corps (15.5%). This is consistent with the U.S. military population. 2 The majority of the population had a length of service between 6 and 10 years (27.4%), closely followed by 11 to 20 years (27.1%). The description and distribution of the referring injury diag- noses are outlined in Table II. Of the 624 service members prescribed an IDEO, 533 (85.4%) had a clear presenting diag- nosis documented in the medical record and of these, 38 (7.1%) had a bilateral diagnosis. The most common injury category that received an IDEO prescription was of injuries at or surrounding the ankle joint (25.0%), followed by tibia injuries (17.5%) and nerve injuries below the knee (16.4%). Less than 20% (n = 121) of the study sample underwent a delayed amputation during the study period. Figure 1 displays the percentage of service members prescribed an IDEO in each injury diagnosis category who later underwent delayed amputa- tion of the injured extremity. Service members with diagnoses in the categories of midfoot/forefoot injuries (28.6%), soft tissue injuries (27.3%), and hindfoot injuries (26.6%) experienced the highest proportion of amputation after IDEO prescription. Those with ankle joint injuries (13.7%) and nerve injuries below the knee (14.3%) demonstrated the lowest rates of ampu- tation. The majority of the delayed amputations (n = 64 [53.8%]) occurred within 3 months after referral for an IDEO with 84% occurring within the first year. DISCUSSION After over a decade of military con flicts in Iraq and Afghanistan and improvements in combat casualty care and body armor, the focus of care of the wounded service member is shifting from acute care to improving the quality of life for those with long- term disability. 14 To adequately care for all injured service mem- bers, a careful evaluation of current rehabilitative treatments is necessary. This study provides information on the demographics, injury pro file, and delayed amputation rates of service members who have been prescribed an IDEO at the CFI after severe LEI. It is an important step toward identifying which injuries are most appropriately treated by this type of lower extremity bracing. When examining the IDEO prescription patterns, an injury involving the ankle joint, including pilon fractures, ankle fusions, and PTOA, was the most frequently reported primary diagnosis (25%), followed by injury to the tibia (17%) and a nerve injury below the knee (16%). Considering nearly 58% of the injuries were at or could in fluence the functioning of the ankle joint, these groupings are consistent with the mechanism of action of the IDEO, which is designed to provide support as well as energy stor- age for the ankle joint during gait and other high-level activities. 11 Less than 20% of the study sample underwent an amputation during the study period. In a prospective observational study of IDEO users completing the RTR clinical pathway, 82% of patients who were initially considering amputation at the start of the program favored limb salvage after receiving an IDEO and completing the RTR program. 12 When examining the indi- vidual diagnostic categories of the present study, 29% of midfoot/forefoot injuries, 27% of soft tissue injuries, and 27% of hindfoot injuries required eventual amputations, whereas the lowest rates of amputation were of nerve injuries below the knee (14%) as well as injuries of ankle (14%). These results are consistent with the categories in published disability data fol- lowing combat-related injuries. 15 With the high prevalence of battle and nonbattle-related seri- ous extremity injuries in our service members, 4 –6 it is important to examine the ef ficacy of treatment modalities for rehabilitative care. This descriptive study is a first step in identifying injured patients who may bene fit the most from an IDEO prescription in terms of both rehabilitation and reducing the likelihood of amputation. Further research is necessary to fully understand this pro
file. Once an injury profile is identified, injured service members can bene fit from having an IDEO prescribed earlier in the rehabilitative process and thus facilitate a more timely recovery of function. In addition, by understanding who will bene
fit most from an IDEO, resources that are currently allo- cated for the unnecessary use of the IDEO could be redirected TABLE II. Referring Injury Diagnosis Categories, N = 533 Injury Type Description n (%) Ankle
Pilon fractures, PTOA, fusion 139 (25.0) Tibia Fractures, excludes pilon fractures 96 (17.5) Nerve injury; below knee Functional deficit below knee 91 (16.4) Hindfoot
PTOA, fusion 79 (14.2) Soft tissue Compartment syndrome, Achilles tendon injuries, quadriceps injuries 33 (5.9) Midfoot/Forefoot Foot pain, forefoot/midfoot PTOA, toe amputation 21 (3.8) Other
Osteomyelitis, late effects of fracture, nerve injury above knee 93 (17.4) PTOA, post-traumatic osteoarthritis. FIGURE 1. Proportion of amputations by diagnostic category. MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 79 Descriptive Characteristics and Amputation Rates With Use of IDEO for other treatment options. This injury pro file should not take the place of clinical decision-making but rather enhance the cur- rent knowledge base and help to inform both clinicians and ser- vice members as decisions on care are made. One of the limitations of this study is the potential for selec- tion bias since the study sample was one of convenience and included only service members who were prescribed an IDEO at the CFI. In addition, a clear presenting diagnosis was docu- mented in only 85% of the total study sample and acute diagno- ses, side of injury, or mechanism of injury (including combat or noncombat) was not available for the majority of the sample. Since the side of injury is unknown, it is possible that the lower extremity with an amputation was opposite to the lower extrem- ity with the IDEO prescription. The amputation rate would be an overestimation if this occurred. Although a functional bene fit to the use of the IDEO compared to other AFOs has been dem- onstrated, 11 the number of patients who bene fited from the IDEO from a functional rehabilitation standpoint is unknown. This study reports IDEO prescription but cannot determine the extent to which the treatment may have been ef ficacious. In addi- tion, the current study suffers from some small sample sizes in the diagnostic groups. Although the midfoot/forefoot had the highest proportion of amputations, one or two individuals having an amputation in another diagnostic group could shift that percentage signi
ficantly. It will be beneficial for future studies to estimate the weighted amputation probability for each diagnosis group. Although a presenting diagnosis was not available for the entire study sample, a quali fied clinician from the armed forces validated a random 10% of the referral diagnosis with electronic military medical record system. The validation process provided data quality assurance to the diagnostic category data element, which was a key component of the analysis. A strength of the study was that multiple datasets were able to be merged to include primary data and secondary data. The primary dataset identi
fied the study sample and presenting diagnosis whereas secondary datasets provided access to a large volume of medi- cal data for validation and augmentation of primary data. This is the first study to comprehensively examine the demo- graphics, referral diagnoses, and amputation outcomes of a sam- ple of service members prescribed the IDEO to facilitate function of an injured lower extremity. The majority of the service mem- bers had a presenting diagnosis at or near the ankle, and can potentially bene fit from an AFO designed to support the joint and augment some of the lost ankle function. Twenty percent of the sample underwent eventual amputation during the year follow- ing initial IDEO prescription. This study is a first step in catego- rizing primary injuries that may bene fit from IDEO prescription and determining which injuries undergo delayed amputation at higher rates. Longitudinal tracking of IDEO users and identi fi- cation of functional outcomes will provide additional information on the ef ficacy of this device for rehabilitation after an LEI. APPENDIX A ICD-9 Codes for Amputations 89600 89620
89700 89610
89630 89710
89720 89760
V4975 89730
89770 V4976
89740 V4973
V4977 89750
V4974 APPENDIX B Procedure Codes for Amputation 8410
8414 8417
8446 8412
8415 8440
8447 8413
8416 8445
8448 REFERENCES 1. Owens BD, Kragh JF, Macaitis J, Svoboda DJ, Wenke JC: Characteri- zation of extremity Wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Orthop Trauma 2007; 21(4): 254 –57.
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MILITARY MEDICINE, Vol. 181, November/December Supplement 2016 80 Descriptive Characteristics and Amputation Rates With Use of IDEO |