Evaluation of the Stability of Osseointegrated Implant in Amputees

Amputation Clinical Trial

— METACOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836755
• Other study ID #: 33/18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: May 8, 2024

Study information

• Verified date: May 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 8, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Amputation
• Prosthesis Failure
• Prosthesis Migration

Intervention

Diagnostic Test:
• Metacos
Evaluation of stability of implant by RSA technique

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (4)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro, Scuola Universitaria Superiore Sant'Anna Pisa, University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotation	Rotations X, Y, Z (in degrees) of the implant with respect to the bone	24 months
Primary	Translation	Translations X, Y, Z (in mm) of the implant with respect to the bone	24 months
Secondary	Health-related quality of life	36-Item Short Form Survey (SF36 )	24 months
Secondary	Pain evaluation	Visual Analog Scale (VAS)	24 months
Secondary	Lower limb: Autonomy	Barthel Index	24 months
Secondary	lower limb: Mobility	Rivermead Mobility Index	4 months
Secondary	Upper limb: functionality	The Disabilities of the Arm, Shoulder and Hand (DASH)	24 months
Secondary	Upper Limb: Development and evaluation of the activities measure for upper limb amputees	Activities Measure for Upper Limb Amputees (AM-ULA)	24 months