Evaluation of the Stability of Osseointegrated Implant in Amputees

Not Applicable

Completed

• Conditions: Amputation; Prosthesis Migration

• Registration Number: NCT03836755
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Primary Completion: 2021-12-31
• Status Verified: 2024-05
• Study Completion: 2024-05-08
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rotation	24 months	Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Translation	24 months	Translations X, Y, Z (in mm) of the implant with respect to the bone

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy