Osseointegrated Prostheses for the Rehabilitation of Amputees

Not Applicable

Active, not recruiting

• Conditions: Transfemoral Amputation
• Interventions: Device: OPRA Implant System

• Registration Number: NCT01725711
• Lead Sponsor: Integrum

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Transfemoral amputation

Exclusion Criteria

• Transfemoral amputation due to vascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implant System	OPRA Implant System	-

Primary Outcome Measures

Name	Time	Method
Q-TFA Prosthetic Use Score	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.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, VG, Sweden