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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014