Osseointegrated Prostheses for the Rehabilitation of Amputees.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transfemoral Amputation
- Sponsor
- Integrum
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Q-TFA Prosthetic Use Score
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Transfemoral amputation
Exclusion Criteria
- •Transfemoral amputation due to vascular disease
Outcomes
Primary Outcomes
Q-TFA Prosthetic Use Score
Time Frame: 0,1,2,3,5,7,10,15,20 years
The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline.