Osseointegrated Prostheses for the Rehabilitation of Amputees
This trial is active, not recruiting.
|Treatment||opra implant system|
|Collaborator||Sahlgrenska University Hospital, Sweden|
|Start date||May 1999|
|End date||May 2027|
|Trial size||51 participants|
|Trial identifier||NCT01725711, R402-98|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Q-TFA Prosthetic Use Score
time frame: 0,1,2,3,5,7,10,15,20 years
Male or female participants from 20 years up to 70 years old.
- Transfemoral amputation
- Transfemoral amputation due to vascular disease
|Official title||Osseointegrated Prostheses for the Rehabilitation of Amputees.|
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