OPRA: Osseointegrated Prostheses for the Rehabilitation of Amputees

• Sponsor: Integrum (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01725711
• Collaborator: Sahlgrenska University Hospital, Sweden (Other), Göteborg University (Other)
• Enrollment: 51
• Location: 1
• Arm: 1
• Duration (Months): 336
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transfemoral Amputation	Device: OPRA Implant System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Osseointegrated Prostheses for the Rehabilitation of Amputees.
• Study Start Date: May 1, 1999
• Anticipated Primary Completion Date: May 1, 2027
• Anticipated Study Completion Date: May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implant System	Device: OPRA Implant System

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Transfemoral amputation

Exclusion Criteria:

• Transfemoral amputation due to vascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg	VG	Sweden	413 45

Sponsors and Collaborators

• Integrum
• Sahlgrenska University Hospital, Sweden
• Göteborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integrum
• ClinicalTrials.gov Identifier: NCT01725711
• Other Study ID Numbers: R402-98
• First Posted: Nov 14, 2012
• Last Update Posted: Aug 6, 2019
• Last Verified: Aug 1, 2019

Study Results

No Results Posted as of Aug 6, 2019