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

October 15, 2012
November 13, 2012
May 1999
May 2027   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01725711 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Osseointegrated Prostheses for the Rehabilitation of Amputees
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Transfemoral Amputation
Device: OPRA Implant System
Experimental: Implant System
Intervention: Device: OPRA Implant System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
51
May 2027
May 2027   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Transfemoral amputation

Exclusion Criteria:

  • Transfemoral amputation due to vascular disease
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01725711
R402-98
No
Integrum
Integrum
  • Sahlgrenska University Hospital, Sweden
  • Göteborg University
Not Provided
Integrum
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP