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NCT01725711 Clinical Trial

Osseointegrated Prostheses for the Rehabilitation of Amputees

Transfemoral Amputation Clinical Trial

— OPRA  

Official title:
Osseointegrated Prostheses for the Rehabilitation of Amputees.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01725711
Other study ID # R402-98
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1999
Est. completion date May 2027

Study information
Verified date August 2019
Source Integrum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 51
Est. completion date May 2027
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Transfemoral amputation

Exclusion Criteria:

- Transfemoral amputation due to vascular disease

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OPRA Implant System

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg VG

Sponsors (3)
Lead Sponsor Collaborator
Integrum Göteborg University, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Q-TFA Prosthetic Use Score 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
See also
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Completed NCT03296904 - The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study N/A
Completed NCT02219230 - Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation N/A
Completed NCT04023045 - Assist-Knee: Energy-Harvesting Knee Prosthesis N/A
Recruiting NCT06045468 - Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients N/A
Recruiting NCT05989243 - Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation
Recruiting NCT05695911 - Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training N/A
Recruiting NCT05831696 - Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss N/A
Completed NCT01537211 - Functional Outcomes in Dysvascular Transfemoral Amputees N/A
Recruiting NCT06218238 - A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation N/A