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Evaluation of the Stability of Osseointegrated Implant in Amputees — METACOS  

Amputation Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03836755
Study type Interventional
Source Istituto Ortopedico Rizzoli
Contact
Status Completed
Phase N/A
Start date January 1, 2019
Completion date May 8, 2024
View Details
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