TY - JOUR AU - USA, Daniel J. Stinner, MC AB - 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 longer 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 battlefield 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 conflicts have a survival rate that is higher than those injured in previous conflicts.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 injuries, 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 preponderance 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 combat-related amputations occur after attempts at limb reconstruction and are considered late amputations, defined 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 amputation.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 al3 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 battle 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 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 conventional 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 significantly 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 benefits of the IDEO device have been characterized in the fields of biomechanics and recreational activity11,13, 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 quantifying the percentage of patients that have undergone amputation after being prescribed an IDEO and completing the RTR program. Therefore, the purpose of this descriptive epidemiologic study was to comprehensively detail demographic and occupational 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 demographic 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 creating an injury profile of patients who will benefit most from an IDEO and the subsequent rehabilitation. Creating such an injury profile will provide clinicians information on which patients can benefit the most from the IDEO and the RTR training program. MATERIALS AND METHODS The population under study included all injured service members 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 variables representing the most current status on demographic and military characteristics. Injured service members who were prescribed an IDEO at the CFI were identified 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 Pacific 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 November 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 information 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 qualified clinician. An amputation of the lower extremity was identified 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 Classification of Diseases, 9th Revision, Clinical Modification) 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%) service 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%). TABLE I. Demographic Characteristics and Amputation Status of Service Members Prescribed IDEO (N = 624), 2009–2014 Demographic Characteristic  TotalaN = 624, n (%)  AmputationaN = 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 Pacific 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)  Demographic Characteristic  TotalaN = 624, n (%)  AmputationaN = 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 Pacific 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 missing data. View Large TABLE I. Demographic Characteristics and Amputation Status of Service Members Prescribed IDEO (N = 624), 2009–2014 Demographic Characteristic  TotalaN = 624, n (%)  AmputationaN = 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 Pacific 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)  Demographic Characteristic  TotalaN = 624, n (%)  AmputationaN = 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 Pacific 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 missing data. View Large The description and distribution of the referring injury diagnoses are outlined in Table II. Of the 624 service members prescribed an IDEO, 533 (85.4%) had a clear presenting diagnosis 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%). 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)  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. View Large 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)  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. View Large 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 amputation 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 amputation. 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. FIGURE 1. View largeDownload slide Proportion of amputations by diagnostic category. FIGURE 1. View largeDownload slide Proportion of amputations by diagnostic category. DISCUSSION After over a decade of military conflicts 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 members, a careful evaluation of current rehabilitative treatments is necessary. This study provides information on the demographics, injury profile, 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 influence 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 storage 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 individual 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 following combat-related injuries.15 With the high prevalence of battle and nonbattle-related serious extremity injuries in our service members,4,–6 it is important to examine the efficacy of treatment modalities for rehabilitative care. This descriptive study is a first step in identifying injured patients who may benefit 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 profile. Once an injury profile is identified, injured service members can benefit 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 benefit most from an IDEO, resources that are currently allocated for the unnecessary use of the IDEO could be redirected for other treatment options. This injury profile should not take the place of clinical decision-making but rather enhance the current knowledge base and help to inform both clinicians and service members as decisions on care are made. One of the limitations of this study is the potential for selection 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 documented in only 85% of the total study sample and acute diagnoses, 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 extremity with the IDEO prescription. The amputation rate would be an overestimation if this occurred. Although a functional benefit to the use of the IDEO compared to other AFOs has been demonstrated,11 the number of patients who benefited 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 efficacious. In addition, 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 significantly. 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 qualified 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 identified the study sample and presenting diagnosis whereas secondary datasets provided access to a large volume of medical data for validation and augmentation of primary data. This is the first study to comprehensively examine the demographics, referral diagnoses, and amputation outcomes of a sample of service members prescribed the IDEO to facilitate function of an injured lower extremity. The majority of the service members had a presenting diagnosis at or near the ankle, and can potentially benefit 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 following initial IDEO prescription. This study is a first step in categorizing primary injuries that may benefit from IDEO prescription and determining which injuries undergo delayed amputation at higher rates. Longitudinal tracking of IDEO users and identification of functional outcomes will provide additional information on the efficacy of this device for rehabilitation after an LEI. APPENDIX A ICD-9 Codes for Amputations View largeDownload slide View largeDownload slide APPENDIX B Procedure Codes for Amputation View largeDownload slide View largeDownload slide REFERENCES 1. Owens BD, Kragh JF, Macaitis J, Svoboda DJ, Wenke JC Characterization of extremity Wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Orthop Trauma  2007; 21( 4): 254– 57. Google Scholar CrossRef Search ADS PubMed  2. Pew Research Center War and Sacrifice in the Post-9/11 Era. Chapter 6: A profile of the modern military . Washington, DC: Pew Social & Demographic Trends. Available at http://www.pewsocialtrends.org/2011/10/05/chapter-6-a-profile-of-the-modern-military/; accessed August 11, 2015. 3. Holcomb JB, Stansbury LG, Champion HR, Wade C, Bellamy RF Understanding combat casualty care statistics. J Trauma  2006; 60( 2): 397– 01. Google Scholar CrossRef Search ADS PubMed  4. Hauret KG, Jones BH, Bullock SH, Canham-Chervak M, Canada S Musculoskeletal injuries: description of an under-recognized injury problem among military personnel. Am J Prev Med  2010; 38( 1): S61– S70. Google Scholar CrossRef Search ADS PubMed  5. Owens BD, Kragh JF, Wenke JC, Macaitis J, Wade CE, Holcomb JB Combat wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Trauma  2008; 64( 2): 295– 99. Google Scholar CrossRef Search ADS PubMed  6. Eskridge SL, Macera CA, Galarneau MR, et al.   Injuries from combat explosions in Iraq: injury type, location, and severity. Injury  2012; 43( 10): 1678– 82. Google Scholar CrossRef Search ADS PubMed  7. 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Sheean AJ, Krueger CA, Hsu JR Return to duty and disability after combat-related hindfoot injury. J Orthop Trauma  2014; 28( 11): e258– 62. Google Scholar CrossRef Search ADS PubMed  Footnotes 1 We are military service members (or employees of the U.S. Government). This work was prepared as part of our official 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 defines 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 official duties. This study was supported by work unit 60808. Reprint & Copyright © Association of Military Surgeons of the U.S. TI - Descriptive Characteristics and Amputation Rates With Use of Intrepid Dynamic Exoskeleton Orthosis JF - Military Medicine DO - 10.7205/MILMED-D-16-00281 DA - 2016-11-01 UR - https://www.deepdyve.com/lp/oxford-university-press/descriptive-characteristics-and-amputation-rates-with-use-of-intrepid-bjN9eOBZ4s SP - 77 EP - 80 VL - 181 IS - suppl_4 DP - DeepDyve ER -