Condition: Amputation; Traumatic, Leg, Lower · Sponsor: Walter Reed National Military Medical Center
Purpose: Aim 1: Quantify soft tissue complications and infections of service members with transtibial amputations treated with OPRA OI and compare them to transfemoral OI service members. Aim 2: Compare the validated domains, such as functional, quality of life and pain scores, from the preoperative baseline to follow-up visits to determine if persons with transtibial amputations treated with OPRA osseointegrated prostheses demonstrate statistically significant and clinically relevant improvements. Aim 3: Compare physical performance measures preoperatively to follow-up visits for persons with transtibial amputations treated with OPRA osseointegrated prostheses to quantify statistically significant and clinically relevant improvements. Aim 4: Quantify the biomechanical loading and bone quality changes that are directly associated with patient reported outcomes for persons with transtibial amputations treated with OPRA osseointegration. Aim 5: Compare outcome measures between persons with traditional socket prostheses (patients as self-controls) and OPRA OI devices as well as a comparison between persons with transtibial OI and transfemoral OI. Subject Population: Male and female military health care beneficiaries age 22 to 65 years old presenting with a Transtibial limb loss. Study Design: This is a 4-year, prospective cohort FDA pivotal study involving off-label use of the OPRA OI implant in persons with transtibial amputation. Procedures: SURGICAL PROCEDURES: Su…
This description comes directly from the study's public registry record.
Emma L Stewart · 202-549-3229 · emma.l.stewart4.ctr@health.mil
Qingfeng Liu · 240-645-3068 · Qingfeng.liu.ctr@usuhs.edu
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| Orhopaedic Surgery Service, Walter Reed National Military Medical Center | Bethesda, Maryland, United States | Recruiting |
| Department of Orthopaedic Surgery and Department of Anesthesiology & Critical Care Penn Medicine University City | Philadelphia, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06636136