💬In plain words
What the trial is, and whether it could suit you
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 transt
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion 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 prosthesis. The OPRA™ Implant System is intended for skeletally mature patients.
* 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)
Exclusion Criteria:
* 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 remain in the study, unless they would like to withdrawal.
* 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)
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