Osseointegrated Prostheses for the Rehabilitation of Amputees

Osseointegrated Prostheses for the Rehabilitation of Amputees.

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01725711

Acronym

OPRA

Enrollment

Registered

2012-11-14

Start date

1999-05-31

Completion date

2027-05-31

Last updated

2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfemoral Amputation

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.

Interventions

DEVICEOPRA Implant System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Transfemoral amputation

Exclusion criteria

* Transfemoral amputation due to vascular disease

Design outcomes

Primary

Measure	Time frame	Description
Q-TFA Prosthetic Use Score	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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026