Evaluation of the Stability of Osseointegrated Implant in Amputees

Study Overview
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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.

Official Title
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Evaluation of the Stability of Osseointegrated Implant in Upper Limb or Lower Limb Amputees

Conditions
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Prosthesis Migration, Amputation

Intervention / Treatment
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* Diagnostic Test: Metacos


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: METACOS<br>Required to do some motor tasks during static and dynamic RSA | Diagnostic Test: Metacos<br>* Evaluation of stability of implant by RSA technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotation | Rotations X, Y, Z (in degrees) of the implant with respect to the bone | 24 months | 
| Translation | Translations X, Y, Z (in mm) of the implant with respect to the bone | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | 36-Item Short Form Survey (SF36 ) | 24 months | 
| Pain evaluation | Visual Analog Scale (VAS) | 24 months | 
| Lower limb: Autonomy | Barthel Index | 24 months | 
| lower limb: Mobility | Rivermead Mobility Index | 4 months | 
| Upper limb: functionality | The Disabilities of the Arm, Shoulder and Hand (DASH) | 24 months | 
| Upper Limb: Development and evaluation of the activities measure for upper limb amputees | Activities Measure for Upper Limb Amputees (AM-ULA) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osseointegration, implant migration, amputee