Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA)
|ClinicalTrials.gov Identifier: NCT01725711|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2012
Last Update Posted : November 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Transfemoral Amputation||Device: OPRA Implant System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Osseointegrated Prostheses for the Rehabilitation of Amputees.|
|Study Start Date :||May 1999|
|Estimated Primary Completion Date :||May 2027|
|Estimated Study Completion Date :||May 2027|
|Experimental: Implant System||Device: OPRA Implant System|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725711
|Sahlgrenska University Hospital|
|Gothenburg, VG, Sweden, 413 45|