RhizarthrosisNCT05169099
Post-operative Results of the Trapezometacarpal (TMC) Prosthesis for Advanced Pre-operative Deformities
An observational study of Rhizarthrosis and Arthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhizarthrosis, Arthritis
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2014to 30 Jan 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated with trapezometacarpal joint arthroplasty for trapezometacarpal joint arthritis
Who may be able to join
- Patient with TMC joint arthritis
- Patient with adduction <25 degrees
- Patients with Z deformity
- Patient operated for TMC joint arthroplasty
Who cannot join
- TMC arthroplasty implanted for fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Results of Trapeziometacarpal Prostheses According to the Preoperative Deformation
Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.
- Conditions
- Rhizarthrosis, Arthritis
- Keywords
- Trapezometacarpal joint arthritis, Adduction angle <25 degrees, Decrease of the grasping and pinching forces, Z deformity of the thumb
- Medical subject headings
- Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Mobility of the trapezometacarpal joint
Mobility of the trapezometacarpal joint
Measured: 1 day
Secondary outcomes (2)
Number of Participants with Grasping force measured
Grasping force measured
Measured: 1 day
Number of Participants with Pinching force
Pinching force
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start20 Jan 2014
- Primary completion1 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel CHAMMAS, PUPH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169099
- Sponsor's protocol ID
- RECHMPL21_0628
- Status last verified
- Feb 2022
- First submitted
- 1 Nov 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Results of Trapeziometacarpal Prostheses According to the Preoperative Deformation
- ClinicalTrials.gov ID
- NCT05169099
- Acronym / sponsor ID
- RECHMPL21_0628
- Conditions
- Rhizarthrosis, Arthritis
- Keywords
- Trapezometacarpal joint arthritis, Adduction angle <25 degrees, Decrease of the grasping and pinching forces, Z deformity of the thumb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Jan 2014 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 23 Dec 2021 (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.
Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated with trapezometacarpal joint arthroplasty for trapezometacarpal joint arthritis
Key inclusion criteria (4 listed)
- Patient with TMC joint arthritis
- Patient with adduction <25 degrees
- Patients with Z deformity
- Patient operated for TMC joint arthroplasty
Key exclusion criteria (1 listed)
- TMC arthroplasty implanted for fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Mobility of the trapezometacarpal joint
Time frame: 1 day
Mobility of the trapezometacarpal joint
2 secondary outcomes
Number of Participants with Grasping force measured
Time frame: 1 day
Number of Participants with Pinching force
Time frame: 1 day
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 8 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Michel CHAMMAS, PUPH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhizarthrosis and Arthritis, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 1 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 8 Feb 2022. 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 France. 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?
Number of Participants with Mobility of the trapezometacarpal joint (time frame: 1 day). 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 8 Feb 2022.