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

May 23, 2024 updated by: Stefano Zaffagnini, Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: METACOS
Required to do some motor tasks during static and dynamic RSA
Diagnostic test: Metacos
Evaluation of stability of implant by RSA technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rotation
Time Frame: 24 months
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
24 months
Translation
Time Frame: 24 months
Translations X, Y, Z (in mm) of the implant with respect to the bone
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Collaborators

University of Bologna
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Scuola Universitaria Superiore Sant'Anna Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

May 8, 2024

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (Actual)

February 11, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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