Evaluation of the Stability of Osseointegrated Implant in Amputees

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

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-05-08

Brief Summary

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The study concerns the technique of osseointegration that consists of inserting a titanium pin into the bone of the amputated limb. A removable external prosthesis will then be connected to the implant section that protrudes from the soft parts.

The benefits of using an osseointegrated prosthesis are the improved sensory feedback (osseoperception) and absence of the socket. This leads to better anchoring of the prosthesis to the abutment, greater control of the prosthesis and the absence of heat, pain, and pressure sores.

The osseointegrated prosthesis does not reduce the mobility of the limb and promotes good growth of bone and muscle mass. The aim of this study is to evaluate the stability of the osseointegrated implant in trans-femoral and trans-humeral amputees.

The main outcome: quantitative evaluation (rotations, translation and MTPM) of the stability of the implant bone interface by Roentgen Stereo-photogrammetric Analysis (RSA) and follow-up.

The secondary outcome: evaluation of the quality of life improvement in patients through clinical score and satisfaction survey.

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Detailed Description

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Conditions

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Prosthesis Migration Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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METACOS

Required to do some motor tasks during static and dynamic RSA

Group Type OTHER

Metacos

Intervention Type DIAGNOSTIC_TEST

Evaluation of stability of implant by RSA technique

Interventions

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Metacos

Evaluation of stability of implant by RSA technique

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* BMI\<35 kg/m2
* Problem in using socket

Exclusion Criteria

* Diabetes;
* Peripheral vascular diseases;
* Psychiatric problems;
* Pregnancy;
* Rheumatoid arthritis;
* Neurovascular diseases;
* Neurological deficits;
* Amputation of the contralateral limb;
* Infections in progress;
* Immunosuppression;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No