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ACTIVE NOT RECRUITING
NCT01725711
NA

Osseointegrated Prostheses for the Rehabilitation of Amputees

Sponsor: Integrum

View on ClinicalTrials.gov

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

Interventions

DEVICE

OPRA Implant System

Locations (1)

Sahlgrenska University Hospital

Gothenburg, VG, Sweden