NCT03836755

Evaluation of the Stability of Osseointegrated Implant in Amputees

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prosthesis Migration
• Amputation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Metacos	Evaluation of stability of implant by RSA technique

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-31
• Completion: 2024-05-08
• First posted: 2019-02-11
• Last updated: 2024-05-24

Locations

1 site across 1 country: Italy