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NCT06636136 · ClinicalTrials.gov registry record · NA
Transtibial Osseointegration
A NA study of Amputation; Traumatic, Leg, Lower, sponsored by Walter Reed National Military Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT06636136: Recruiting NA study of Amputation; Traumatic, Leg, Lower, sponsored by Walter Reed National Military Medical Center.
NCT06636136 is a NA study of Amputation; Traumatic, Leg, Lower that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 30 participants, above the 15-participant average among 3 other Amputation; Traumatic, Leg, Lower trials with a reported enrollment target (100% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06636136, a NA study of Amputation; Traumatic, Leg, Lower, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
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: Surgery Stage I: The distal part of the tibia is exposed, preferably using existing incisions, to produce an appropriate fasciocutaneous flap. By the use of fluoroscopy and guiding devices the correct position of the fixture in the medullary canal is found. The canal is reamed step by step to a proper diameter to facilitate insertion of the implant. If the bone quality is poor, as determined by the operating surgeon, autologous bone graft from the iliac crest and/or the medullary canal is used. T
Primary Outcome
Collecting the rate of complications after the surgery
Conditions Studied
Interventions
- DEVICE OPRA
Study Locations (2)
Maryland
- Orhopaedic Surgery Service, Walter Reed National Military Medical Center - Bethesda
Pennsylvania
- Department of Orthopaedic Surgery and Department of Anesthesiology & Critical Care Penn Medicine University City - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-05-20 |
| Est. Completion | 2030-04-30 |
| Phase | NA |
What NCT06636136 shows while recruiting
NCT06636136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, above the 15-participant average among 3 other Amputation; Traumatic, Leg, Lower trials with a reported enrollment target (100% higher).
The record links to 1 condition, with Amputation; Traumatic, Leg, Lower appearing as the primary indexed condition, and to 1 intervention - of which OPRA is the first listed.
NCT06636136 reports a single indexed study location in Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06636136 about?
NCT06636136 is a clinical study titled "Transtibial Osseointegration". 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 preoperati...
What is the current status of trial NCT06636136?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-05-20. Estimated completion is 2030-04-30.
What conditions does trial NCT06636136 study?
This clinical trial studies the following conditions: Amputation; Traumatic, Leg, Lower.
What interventions are being tested in trial NCT06636136?
The interventions under investigation include: OPRA (DEVICE).
Who is sponsoring clinical trial NCT06636136?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06636136 being conducted?
This trial has 2 study locations across Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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