Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Osseointegrated Prostheses for the Rehabilitation of Amputees.|
- Q-TFA Prosthetic Use Score [ Time Frame: 0,1,2,3,5,7,10,15,20 years ] [ Designated as safety issue: No ]The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline.
|Study Start Date:||May 1999|
|Estimated Study Completion Date:||May 2027|
|Estimated Primary Completion Date:||May 2027 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725711
|Sahlgrenska University Hospital|
|Gothenburg, VG, Sweden, 413 45|