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Active, Not Recruiting

NCT Number: NCT01725711

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Transfemoral Amputation

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, VG, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Transfemoral amputation

Exclusion criteria

  • Transfemoral amputation due to vascular disease

Treatment and study plan

OPRA Implant System

Device

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Integrum

Industry

Collaborators

  • Göteborg University
  • Sahlgrenska University Hospital

Registry information

Official study title

Osseointegrated Prostheses for the Rehabilitation of Amputees.

Acronym: OPRA

Important dates

Study start
1999
Primary completion
2027
Study completion
2027
First posted
Nov 14, 2012
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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