Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA)

Integrum

Status: Active, not recruiting

Conditions: Transfemoral Amputation

Treatments: Device: OPRA Implant System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01725711

R402-98

Details and patient eligibility

About

Patients with transfemoral amputations (TFA) frequently experience problems related to the use of socket-suspended prostheses 1-3. These problems increase with short or deformed stumps 4. The potential for improvement is substantial. Based on the very good long-term results with osseointegrated titanium implants for edentulous patients 5, osseointegrated hearing aids 6, cranio-facial prostheses 7 and prostheses for thumb-amputated patients 8, the clinical development of osseointegrated prostheses for TFA started in 1990, in Gothenburg, Sweden. The concept has gradually been modified and improved. In 1999, a prospective clinical trial began.

The hypothesis is that the treatment will improve quality of life.

Enrollment: 51 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Transfemoral amputation

Exclusion criteria

• Transfemoral amputation due to vascular disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Implant System

Experimental group

Treatment:

Device: OPRA Implant System