This trial is active, not recruiting.

Condition transfemoral amputation
Treatment opra implant system
Sponsor Integrum
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
opra implant system

Primary Outcomes

Q-TFA Prosthetic Use Score
time frame: 0,1,2,3,5,7,10,15,20 years

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

Inclusion Criteria: - Transfemoral amputation Exclusion Criteria: - Transfemoral amputation due to vascular disease

Additional Information

Official title Osseointegrated Prostheses for the Rehabilitation of Amputees.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Integrum.