Osseointegrated (bone-anchored) prosthesis for below-knee (transtibial) amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The protocol implants the OPRA osseointegration system into the tibia of eligible transtibial amputees and follows them with standardized clinical and radiologic exams and performance testing. Outcomes include soft-tissue complications and infections, patient-reported function, quality of life and pain scores, physical performance measures, and biomechanical and bone-quality metrics. Assessments occur preoperatively and at 6, 12, 24, 36, 48 and 60 months after surgery, with data recorded on electronic case report forms. Procedures are performed by experienced investigators at participating centers including Walter Reed and Penn Medicine.

Why it matters

Who can join: the full rules

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)

Where it's running

• 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

Study contacts

• Principal investigator: Christopher H Renninger, MD — Walter Reed National Military Medical Center
• Study coordinator: Emma L Stewart
• Email: emma.l.stewart4.ctr@health.mil
• Phone: 202-549-3229

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.