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Osseointegrated Prostheses for the Rehabilitation of Amputees
Sponsor: Integrum
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.
Official title: Osseointegrated Prostheses for the Rehabilitation of Amputees.
Key Details
Gender
All
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
1999-05
Completion Date
2027-05
Last Updated
2019-08-06
Healthy Volunteers
No
Conditions
Interventions
OPRA Implant System
Locations (1)
Sahlgrenska University Hospital
Gothenburg, VG, Sweden