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New treatment option for Amputation; Traumatic, Leg, Lower
Official title Transtibial Osseointegration
ClinicalTrials.gov ID: NCT06636136
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Diagnosis of a transtibial amputation age 22-65.
- The OPRA™ Implant System is indicated for patients who have transtibial amputation due to trauma or cancer and who have or are anticipated to have...
- The patient failed to receive benefit from socket prostheses or is expected to not tolerate socket use due to problems such as:
- Recurrent skin infections and ulcerations in the socket contact area
- Pain
You likely can't join if
- The patient's skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray.
- The patient has atypical skeletal anatomy which may affect treatment with OPRA™.
- Examples of atypical skeletal anatomy.
- Skeletal dimensions outside defined interval.
- Development anomalies.
- Conditions which are not amenable to device insertion such as deformities, fracture, infection.
See the full eligibility criteria
- Diagnosis of a transtibial amputation age 22-65.
- The OPRA™ Implant System is indicated for patients who have transtibial amputation due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket...
- The patient failed to receive benefit from socket prostheses or is expected to not tolerate socket use due to problems such as:
- Recurrent skin infections and ulcerations in the socket contact area
- Pain
- A short stump preventing the use of socket prosthesis
- Volume fluctuation in the stump
- Soft tissue scarring
- Extensive area of skin grafting
- Socket retention problems due to excessive perspiration
- Restricted mobility
- Eligible to receive care at Military Treatment Facility ( WRNMMC only)
- DEERS-eligible ( WRNMMC only)
- The patient's skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray.
- The patient has atypical skeletal anatomy which may affect treatment with OPRA™.
- Examples of atypical skeletal anatomy.
- Skeletal dimensions outside defined interval.
- Development anomalies.
- Conditions which are not amenable to device insertion such as deformities, fracture, infection.
- The patient would have less than 2 mm of remaining cortex bone available around the implant, if implanted.
- Osteoporosis.
- The patient is older than 65 years and younger than 22 years.
- BMI over 35.
- Do not treat patients with the following concurrent diseases:
- Severe peripheral vascular disease.
- Diabetic mellitus with complications.
- Neuropathy or neuropathic disease.
- Active infection or dormant bacteria.
- Metabolic bone disease and/or metastatic lesions in the residual tibia.
- Pregnancy before the surgery female patients will take a pregnancy test) Note: Patients who become pregnant, after surgery stage I, surgery stage II will be delayed until safe to do so by their doctor. The patient will...
- The patient is not expected to be able to comply with treatment and follow up requirements.
- Participants unable to sign their own consent (No legally authorized representatives may provide consent)
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.