Trapeziometacarpal OsteoarthritisNCT07169474
Treatment of Peritrapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty in 300 Patients
A study testing Isolated trapeziometacarpal arthroplasty with double mobility in people with Trapeziometacarpal Osteoarthritis, run by Clinique Saint Jean, France at 1 site in France.
Trial summary
The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis
- What is being tested?
- Isolated trapeziometacarpal arthroplasty with double mobility
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of surgery on the affected thumb.
- Systemic inflammatory diseases (e.g. rheumatoid arthritis).
- Active infection or history of joint infection of the upper limb.
- Inability to participate in post-operative follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique St jean sud de france
Montpellier, 34430
Cecile Spirito, 00304 67 41 34 53, cecile.spirito@capsante.fr
About this study
Official title: Treatment of Peri-trapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty
The aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms.
The primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively.
The study design is a follow-up study of a multicenter cohort.
- Conditions
- Trapeziometacarpal Osteoarthritis
- Being tested
- Isolated trapeziometacarpal arthroplasty with double mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated trapeziometacarpal arthroplasty with double mobilityProcedure or surgery
Isolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits.
| Study group | Role | What they receive |
|---|---|---|
| Isolated trapeziometacarpal arthroplasty | Experimental | Isolated TM arthroplasty with double mobility in all cases, using a MAIA (Laboratoire LEPINE) or TOUCH (Laboratoire KERIMEDICAL) prosthesis, depending on the surgeons' habits. Participating surgeons will follow a common operating protocol to ensure consistency of procedures. Receives: Procedure: Isolated trapeziometacarpal arthroplasty with double mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score
Change in Quick DASH functional score between inclusion (preoperative) and one year postoperatively, from 0 = no disability to 100 = maximum disability.
Measured: One year
Secondary outcomes (8)
Patient satisfaction
Likert satisfaction scale at 3 months, 6 months and 12 months post-operative. Chossing between very satisfied , Satisfied , No opinion , Dissatisfied or Very dissatisfied
Measured: 3 months, 6 months and 12 months post-operative
Complication or surgery
Need for repeat surgery and any post-operative complication during 12-month follow-up. Need for additional surgery on STT joint (= if pain on palpation and flexion/extension mobilization)
Measured: One year
Radiographic evaluation
Radiographic evaluation: absence of prosthesis complications
Measured: one year
Pain in the operated hand
Visual Analogue Scale (VAS) for pain preoperatively at 3 months, 6 months and 12 months postoperatively, from 0 (no pain) to 10 (maximum pain).
Measured: 3 months, 6 months and 12 months postoperatively
Pinch and grip force
Pinch and grip force measured with dynamometer preoperatively, at 3 months, 6 months and 12 months postoperatively.
Measured: 3 months, 6 months and 12 months postoperatively
Range of motion of the thumb
Range of motion of the thumb measured relative to the 2nd metacarpal: antepulsion, retropulsion, abduction and adduction preoperatively, at 3 months, 6 months and 12 months postoperatively
Measured: 3 months, 6 months and 12 months postoperatively
Wrist range of motion
Wrist range of motion: flexion, extension, radial tilt and ulnar tilt preoperatively, at 3 months, 6 months and 12 months postoperatively
Measured: 3 months, 6 months and 12 months postoperatively
Amplitude of possible metacarpophalangeal hyperextension
Amplitude of possible metacarpophalangeal hyperextension preoperatively at 3 months, 6 months and 12 months postoperatively
Measured: preoperatively at 3 months, 6 months and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Sep 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin DEGEORGE, Clinique Saint Jean, France
- Investigators
- benjamin Degeorge, Principal investigator, Clinique Saint jean sud de france
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169474
- Sponsor's protocol ID
- TM2025
- Status last verified
- Nov 2025
- First submitted
- 29 Aug 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Peri-trapezial Osteoarthritis With Isolated Trapeziometacarpal Arthroplasty
- ClinicalTrials.gov ID
- NCT07169474
- Acronym / sponsor ID
- TM2025
- Conditions
- Trapeziometacarpal Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 11 Sep 2025 (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 aim of this clinical trial is to assess the functional outcomes of isolated trapeziometacarpal joint arthroplasty in adult patients requiring surgical management of trapeziometacarpal osteoarthritis, with or without associated symptoms.
The primary endpoint is the evolution of the Quick DASH functional score between inclusion (preoperative) and one year postoperatively.
The study design is a follow-up study of a multicenter cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolated trapeziometacarpal arthroplasty | Experimental | Procedure: Isolated trapeziometacarpal arthroplasty with double mobilityIsolated TM arthroplasty with double mobility in all cases, using a MAIA (Laboratoire LEPINE) or TOUCH (Laboratoire KERIMEDICAL) prosthesis, depending on the surgeons' habits. Participating surgeons will follow a common operating protocol to ensure consistency of procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- History of surgery on the affected thumb.
- Systemic inflammatory diseases (e.g. rheumatoid arthritis).
- Active infection or history of joint infection of the upper limb.
- Inability to participate in post-operative follow-up.
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 |
|---|---|---|
| Isolated trapeziometacarpal arthroplasty with double mobilityIsolated trapeziometacarpal arthroplasty with double mobility in all cases, using a MAIA or TOUCH prosthesis depending on the operator's habits. | Procedure or surgery | Isolated trapeziometacarpal arthroplasty |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score
Time frame: One year
Change in Quick DASH functional score between inclusion (preoperative) and one year postoperatively, from 0 = no disability to 100 = maximum disability.
8 secondary outcomes
Patient satisfaction
Time frame: 3 months, 6 months and 12 months post-operative
Complication or surgery
Time frame: One year
Radiographic evaluation
Time frame: one year
Pain in the operated hand
Time frame: 3 months, 6 months and 12 months postoperatively
Pinch and grip force
Time frame: 3 months, 6 months and 12 months postoperatively
Range of motion of the thumb
Time frame: 3 months, 6 months and 12 months postoperatively
Wrist range of motion
Time frame: 3 months, 6 months and 12 months postoperatively
Amplitude of possible metacarpophalangeal hyperextension
Time frame: preoperatively at 3 months, 6 months and 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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.
benjamin Degeorge principal investigator
Clinique Saint jean sud de france
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated trapeziometacarpal arthroplasty with double mobility in people with Trapeziometacarpal Osteoarthritis, run by Clinique Saint Jean, France 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 0 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecile Spirito (0033467413399, cecile.spirito@capsante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (Quick Dash) functional score (time frame: One year). 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 25 Nov 2025.