Evaluation of the Stability of Osseointegrated Implant in Amputees (METACOS)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Prosthesis Migration; Amputation

Treatments: Diagnostic Test: Metacos

Study type: Interventional

Funder types: Other

Identifiers

NCT03836755

33/18

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

METACOS

Other group

Description:

Required to do some motor tasks during static and dynamic RSA

Treatment:

Diagnostic Test: Metacos