Prosthesis MigrationMETACOSNCT03836755
Evaluation of the Stability of Osseointegrated Implant in Amputees
A study testing Metacos in people with Prosthesis Migration and Amputation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prosthesis Migration, Amputation
- What is being tested?
- Metacos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 8 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI<35 kg/m2
- Problem in using socket
Who cannot join
- Diabetes;
- Peripheral vascular diseases;
- Psychiatric problems;
- Pregnancy;
- Rheumatoid arthritis;
- Neurovascular diseases;
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- Neurological deficits;
- Amputation of the contralateral limb;
- Infections in progress;
- Immunosuppression;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Metacos
- Keywords
- osseointegration, implant migration, amputee
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetacosDiagnostic test
Evaluation of stability of implant by RSA technique
| Study group | Role | What they receive |
|---|---|---|
| METACOS | Other | Required to do some motor tasks during static and dynamic RSA Receives: Diagnostic Test: Metacos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotation
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Measured: 24 months
Translation
Translations X, Y, Z (in mm) of the implant with respect to the bone
Measured: 24 months
Secondary outcomes (6)
Health-related quality of life
36-Item Short Form Survey (SF36 )
Measured: 24 months
Pain evaluation
Visual Analog Scale (VAS)
Measured: 24 months
Lower limb: Autonomy
Barthel Index
Measured: 24 months
lower limb: Mobility
Rivermead Mobility Index
Measured: 4 months
Upper limb: functionality
The Disabilities of the Arm, Shoulder and Hand (DASH)
Measured: 24 months
Upper Limb: Development and evaluation of the activities measure for upper limb amputees
Activities Measure for Upper Limb Amputees (AM-ULA)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis MigrationStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro, Scuola Universitaria Superiore Sant'Anna Pisa
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836755
- Sponsor's protocol ID
- 33/18
- Acronym
- METACOS
- Status last verified
- May 2024
- First submitted
- 5 Feb 2019
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stability of Osseointegrated Implant in Upper Limb or Lower Limb Amputees
- ClinicalTrials.gov ID
- NCT03836755
- Acronym / sponsor ID
- METACOS / 33/18
- Conditions
- Prosthesis Migration, Amputation
- Keywords
- osseointegration, implant migration, amputee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- University of Bologna, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro, Scuola Universitaria Superiore Sant'Anna Pisa
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| METACOS | Other | Diagnostic Test: MetacosRequired to do some motor tasks during static and dynamic RSA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI<35 kg/m2
- Problem in using socket
Key exclusion criteria (10 listed)
- Diabetes;
- Peripheral vascular diseases;
- Psychiatric problems;
- Pregnancy;
- Rheumatoid arthritis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetacosEvaluation of stability of implant by RSA technique | Diagnostic test | METACOS |
Primary outcome
Rotation
Time frame: 24 months
Rotations X, Y, Z (in degrees) of the implant with respect to the bone
Translation
Time frame: 24 months
Translations X, Y, Z (in mm) of the implant with respect to the bone
6 secondary outcomes
Health-related quality of life
Time frame: 24 months
Pain evaluation
Time frame: 24 months
Lower limb: Autonomy
Time frame: 24 months
lower limb: Mobility
Time frame: 4 months
Upper limb: functionality
Time frame: 24 months
Upper Limb: Development and evaluation of the activities measure for upper limb amputees
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Prosthesis Migration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacos in people with Prosthesis Migration and Amputation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotation (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.