Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA)

August 5, 2019 updated by: Integrum

Osseointegrated Prostheses for the Rehabilitation of Amputees.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • VG
      • Gothenburg, VG, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Transfemoral amputation

Exclusion Criteria:

  • Transfemoral amputation due to vascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Implant System
Device: OPRA Implant System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0,1,2,3,5,7,10,15,20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrum

Collaborators

Göteborg University
Sahlgrenska University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Primary Completion (ANTICIPATED)

May 1, 2027

Study Completion (ANTICIPATED)

May 1, 2027

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (ESTIMATE)

November 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • R402-98

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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