Evaluation of the Stability of Osseointegrated Implant in Amputees (METACOS)
Primary Purpose
Prosthesis Migration, Amputation
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Metacos
Sponsored by
About this trial
This is an interventional diagnostic trial for Prosthesis Migration focused on measuring osseointegration, implant migration, amputee
Eligibility Criteria
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;
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
METACOS
Arm Description
Required to do some motor tasks during static and dynamic RSA
Outcomes
Primary Outcome Measures
Rotation
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Translation
Translations X, Y, Z (in mm) of the implant with respect to the bone
Secondary Outcome Measures
Health-related quality of life
36-Item Short Form Survey (SF36 )
Pain evaluation
Visual Analog Scale (VAS)
Lower limb: Autonomy
Barthel Index
lower limb: Mobility
Rivermead Mobility Index
Upper limb: functionality
The Disabilities of the Arm, Shoulder and Hand (DASH)
Upper Limb: Development and evaluation of the activities measure for upper limb amputees
Activities Measure for Upper Limb Amputees (AM-ULA)
Full Information
NCT ID
NCT03836755
First Posted
February 5, 2019
Last Updated
May 16, 2023
Sponsor
Istituto Ortopedico Rizzoli
Collaborators
University of Bologna, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro, Scuola Universitaria Superiore Sant'Anna Pisa
1. Study Identification
Unique Protocol Identification Number
NCT03836755
Brief Title
Evaluation of the Stability of Osseointegrated Implant in Amputees
Acronym
METACOS
Official Title
Evaluation of the Stability of Osseointegrated Implant in Upper Limb or Lower Limb Amputees
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli
Collaborators
University of Bologna, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro, Scuola Universitaria Superiore Sant'Anna Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Migration, Amputation
Keywords
osseointegration, implant migration, amputee
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
METACOS
Arm Type
Other
Arm Description
Required to do some motor tasks during static and dynamic RSA
Intervention Type
Diagnostic Test
Intervention Name(s)
Metacos
Intervention Description
Evaluation of stability of implant by RSA technique
Primary Outcome Measure Information:
Title
Rotation
Description
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Time Frame
24 months
Title
Translation
Description
Translations X, Y, Z (in mm) of the implant with respect to the bone
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
36-Item Short Form Survey (SF36 )
Time Frame
24 months
Title
Pain evaluation
Description
Visual Analog Scale (VAS)
Time Frame
24 months
Title
Lower limb: Autonomy
Description
Barthel Index
Time Frame
24 months
Title
lower limb: Mobility
Description
Rivermead Mobility Index
Time Frame
4 months
Title
Upper limb: functionality
Description
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame
24 months
Title
Upper Limb: Development and evaluation of the activities measure for upper limb amputees
Description
Activities Measure for Upper Limb Amputees (AM-ULA)
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Stability of Osseointegrated Implant in Amputees
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