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Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA)

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ClinicalTrials.gov Identifier: NCT01725711
Recruitment Status : Active, not recruiting
First Posted : November 14, 2012
Last Update Posted : November 14, 2012
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Göteborg University
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Transfemoral Amputation Device: OPRA Implant System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
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 1999
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Q-TFA Prosthetic Use Score [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Transfemoral amputation

Exclusion Criteria:

  • Transfemoral amputation due to vascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725711


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

Responsible Party: Integrum
ClinicalTrials.gov Identifier: NCT01725711     History of Changes
Other Study ID Numbers: R402-98
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012