Evaluation of the Stability of Osseointegrated Implant in Amputees

NCT03836755 | Completed

• 1 other identifier: 33/18
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis Migration; Amputation

Keywords

osseointegration; implant migration; amputee

Outcome Measures

Primary Outcomes (2)

• Rotation

  Rotations X, Y, Z (in degrees) of the implant with respect to the bone

  24 months

• Translation

  Translations X, Y, Z (in mm) of the implant with respect to the bone

  24 months

Secondary Outcomes (6)

• Health-related quality of life

  24 months

• Pain evaluation

  24 months

• Lower limb: Autonomy

  24 months

• lower limb: Mobility

  4 months

• Upper limb: functionality

  24 months

Study Arms (1)

METACOS

OTHER

Required to do some motor tasks during static and dynamic RSA

Diagnostic Test: Metacos

Interventions

Metacos DIAGNOSTIC_TEST

Evaluation of stability of implant by RSA technique

METACOS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI\<35 kg/m2
• Problem in using socket

You may not qualify if:

• Diabetes;
• Peripheral vascular diseases;
• Psychiatric problems;
• Pregnancy;
• Rheumatoid arthritis;
• Neurovascular diseases;
• Neurological deficits;
• Amputation of the contralateral limb;
• Infections in progress;
• Immunosuppression;

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• University of Bologna: collaborator
• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: collaborator
• Scuola Universitaria Superiore Sant'Anna Pisa: collaborator

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor and Head of department

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 11, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: May 8, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

IT (1)