Osseointegrated Prostheses for the Rehabilitation of Amputees

NCT ID: NCT01725711

Last Updated: 2019-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Transfemoral Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implant System

Group Type EXPERIMENTAL

OPRA Implant System

Intervention Type DEVICE

Interventions

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OPRA Implant System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Transfemoral amputation

Exclusion Criteria

* Transfemoral amputation due to vascular disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role collaborator

Integrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahlgrenska University Hospital

Gothenburg, VG, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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R402-98

Identifier Type: -

Identifier Source: org_study_id

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