Trials / Active Not Recruiting
Active Not RecruitingNCT01725711
Osseointegrated Prostheses for the Rehabilitation of Amputees
Osseointegrated Prostheses for the Rehabilitation of Amputees.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Integrum · Industry
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OPRA Implant System |
Timeline
- Start date
- 1999-05-01
- Primary completion
- 2027-05-01
- Completion
- 2027-05-01
- First posted
- 2012-11-14
- Last updated
- 2019-08-06
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01725711. Inclusion in this directory is not an endorsement.