Osteoarthritis ThumbNCT06546306
Post Market Clinical Follow-Up TOUCH® CMC 1
An observational study of Osteoarthritis Thumb, run by Keri Medical SA at 6 sites in France.
Trial summary
Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- TOUCH® CMC 1
- Type of treatment
- Medical device
- How many people
- 216 participants
- Where
- 6 sitesFrance
- Study dates
- 22 Nov 2019to Dec 2031
- Phase
- Observational
- 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
Study population: Any type of population requiring a surgical procedure covered by the device indications and contraindications.
Who may be able to join
- Adult patients (age ≥ 18 years),
- Patients suffering from rhizarthrosis (I - IV based on the Dell classification),
- Pain >3 on the VAS scale,
- Patients to undergo a replacement of the trapeziometacarpal joint with the Touch® dual mobility trapeziometacarpal prosthesis.
Who cannot join
- Pregnant women,
- Patients with contraindications to surgery in general,
- Patients suffering from Temporary Regional Pain Syndrome (TRPS),
- Patients with a severe or chronic, local or systemic infection,
- Patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint,
- Patients with bone demineralization or destruction that may affect the proper fixation of the implant,
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- Patients whose bone dimensions are incompatible with the implant dimensions,
- The combination of the Touch® prosthesis with other components of another origin is not authorized,
- Patients with allergies to the components of the product or with known allergies (chromium, cobalt, nickel),
- Patients with an intellectual disability who cannot, therefore, follow the instructions of their surgeon,
- Patient with scaphoid-trapezium-trapezoid (STT) arthritis,
- Patient requiring revision of a trapeziometacarpal prosthesis,
- Patient who has undergone a TMC joint infiltration within 3 months of the expected date of replacement of the joint with a Touch® prosthesis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre de la main du Pays d'Aix
Aix-en-Provence, 13090
Clinic of Chataigneraie
Beaumont, 63110
Orthopaedics and Trauma Surgery Practice
Bezannes, 51430
Médipôle De Savoie
Challes-les-Eaux, 73190
Medical Office of Dr TCHURUKDICHIAN
Dijon, 21000
Medical Office Archimed
Lesquin, 59810
About this study
Official title: Efficacy and Safety of the Touch® Dual Mobility Trapeziometacarpal Prosthesis and Its Surgical Instruments Set in the Treatment of Basal Thumb Osteoarthritis: Post-market Observational Clinical Study.
Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.
The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck).
The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force.
Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.
- Conditions
- Osteoarthritis Thumb
- Being tested
- TOUCH® CMC 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOUCH® CMC 1Device
TOUCH® prosthesis is a total CMC 1 (1st Carpo-metacarpal) joint replacement prosthesis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility and pain
At 3 months post-surgery, the proportion of patients with a Kapandji score > 8 and a pain score ≤ 3 on a VAS scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start22 Nov 2019
- Primary completion22 Feb 2022
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keri Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546306
- Sponsor's protocol ID
- 2019-A02352-55
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Touch® Dual Mobility Trapeziometacarpal Prosthesis and Its Surgical Instruments Set in the Treatment of Basal Thumb Osteoarthritis: Post-market Observational Clinical Study.
- ClinicalTrials.gov ID
- NCT06546306
- Acronym / sponsor ID
- 2019-A02352-55
- Conditions
- Osteoarthritis Thumb
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Keri Medical SAIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- Dec 2031 (estimated)
- First posted
- 9 Aug 2024 (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.
Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.
The cement-free dual mobility Touch® prosthesis consists of a metacarpal implant (stem), a trapezium implant (cup), and a connection implant (neck).
The main objective of this study is to describe the performance and safety of the Touch® prosthesis used with its instruments set in accordance with its intention and CE marking in force.
Performance and safety will be assessed over the short and long term in accordance with the life cycle of the Touch® prosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any type of population requiring a surgical procedure covered by the device indications and contraindications.
Key inclusion criteria (4 listed)
- Adult patients (age ≥ 18 years),
- Patients suffering from rhizarthrosis (I - IV based on the Dell classification),
- Pain >3 on the VAS scale,
- Patients to undergo a replacement of the trapeziometacarpal joint with the Touch® dual mobility trapeziometacarpal prosthesis.
Key exclusion criteria (13 listed)
- Pregnant women,
- Patients with contraindications to surgery in general,
- Patients suffering from Temporary Regional Pain Syndrome (TRPS),
- Patients with a severe or chronic, local or systemic infection,
- Patients with severe muscle, neurological or vascular impairments affecting the trapezium-metacarpal joint,
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 |
|---|---|---|
| TOUCH® CMC 1TOUCH® prosthesis is a total CMC 1 (1st Carpo-metacarpal) joint replacement prosthesis. | Device | – |
Primary outcome
Mobility and pain
Time frame: 3 months
At 3 months post-surgery, the proportion of patients with a Kapandji score > 8 and a pain score ≤ 3 on a VAS scale.
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 11 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis Thumb
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Thumb, run by Keri Medical SA at 6 sites 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 13 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Mobility and pain (time frame: 3 months). 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 11 Sep 2025.