Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Göteborg University
Information provided by (Responsible Party):
Integrum
ClinicalTrials.gov Identifier:
NCT01725711
First received: October 15, 2012
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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 Intervention
Transfemoral Amputation
Device: OPRA Implant System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Osseointegrated Prostheses for the Rehabilitation of Amputees.

Resource links provided by NLM:


Further study details as provided by Integrum:

Primary Outcome Measures:
  • Q-TFA Prosthetic Use Score [ Time Frame: 0,1,2,3,5,7,10,15,20 years ] [ Designated as safety issue: No ]
    The primary efficacy variable is the change in Q-TFA Prosthetic Use Score as compared baseline.


Enrollment: 51
Study Start Date: May 1999
Estimated Study Completion Date: May 2027
Estimated Primary Completion Date: May 2027 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implant System Device: OPRA Implant System

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Transfemoral amputation

Exclusion Criteria:

  • Transfemoral amputation due to vascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725711

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, VG, Sweden, 413 45
Sponsors and Collaborators
Integrum
Sahlgrenska University Hospital, Sweden
Göteborg University
  More Information

No publications provided

Responsible Party: Integrum
ClinicalTrials.gov Identifier: NCT01725711     History of Changes
Other Study ID Numbers: R402-98
Study First Received: October 15, 2012
Last Updated: November 13, 2012
Health Authority: Sweden: The National Board of Health and Welfare
Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on April 17, 2014