Osteoarthritis ThumbPAS002NCT07405983
TOUCH® CMC 1 New Enrollment US Study
An observational study of Osteoarthritis Thumb and Thumb Carpometacarpal Joint Osteoarthritis, run by Keri Medical SA at 4 sites in United States.
Trial summary
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Osteoarthritis Thumb, Thumb Carpometacarpal Joint Osteoarthritis
- What is being tested?
- TOUCH® CMC 1 Prosthesis
- Type of treatment
- Medical device
- How many people
- 163 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Mar 2026to Feb 2030
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects participating in this study will be recruited from the investigators' standard patient populations. All patients presenting with osteoarthritis of the 1st carpometacarpal joint will be evaluated for study participation based on the inclusion/exclusion criteria. Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. The investigator maintains exclusive responsibility for the inclusion and exclusion of any potential study participant.
Who may be able to join
- Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
- Adult (≥ 22 years of age) at the time of enrollment
- Willing and able to sign the study Informed Consent
Who cannot join
- Acute or chronic infections, local or systemic
- Muscular, neurological, or vascular severe deficiency affecting the joint
- Inadequate bone quality or quantity preventing the implant fixation
- Bones dimensions incompatible with implant sizes
- Patients who are allergic to the product's materials
- Any concomitant disorder that may affect the function of the implant (e.g., osteoarthritis of the wrist)
Show all 10Show fewer
- Skeletally immature (i.e., pediatric population, <22 years of age)
- Pregnant or nursing women
- Patients with contraindications to surgery in general
- Patients with an intellectual disability who cannot follow the instructions of their surgeon.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Colorado, Anschutz School of Medicine
Aurora, Colorado, 80045
Layla Haji, 720-579-8971, layla.haji@ucdenver.edu
Louis W Catalano III, MD
- Recruiting
Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Melanie Glover, 463-249-2613, mglover@orthoindy.com
Thomas Kaplan, MD
- Recruiting
Duke University Medical Center, Department of Orthopaedic Surgery
Morrisville, North Carolina, 27560
Jacob Carpenter, 919-660-5017, jacob.carpenter@duke.edu
Tyler Pidgeon, MD
- Not yet recruiting
University of Texas Health San Antonio, Department of Orthopaedics
San Antonio, Texas, 78229
Nick Lucio, 210-567-5142, luciond@uthscsa.edu
Brian Sager, MD
About this study
Official title: Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.
Read the detailed description
TOUCH® CMC 1 (Carpometacarpal) Prosthesis is a cementless, ball-and-socket dual-mobility, total CMC1 joint replacement prosthesis, designed to treat osteoarthritis of the base of the thumb. The TOUCH® CMC 1 Prosthesis was approved by FDA (P240020) on July 10, 2025. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post Approval Study Report per the requirements set forth in the approval.
- Being tested
- TOUCH® CMC 1 Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOUCH® CMC 1 ProsthesisDevice
The TOUCH® CMC 1 Prosthesis is a commercially available thumb joint implant which is made up of three modular components:
- TOUCH Cup: a stainless steel trapezial implant (cup) with a dual coating of plasma sprayed titanium and hydroxyapatite; TOUCH Cup is available in two options: Spherical and Conical
- TOUCH Liner and Neck: a junction implant (neck) topped with a liner pre-assembled to stainless steel neck
- TOUCH Stem: a titanium alloy metacarpal implant (stem) with a dual coating of plasma sprayed titanium and hydroxyapatite
| Study group | Role | What they receive |
|---|---|---|
| TOUCH® CMC 1 Prosthesis | Not described Receives: Device: TOUCH® CMC 1 Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Composite Success
- Improvement of pain: A clinically meaningful improvement in pain during activities defined as a decrease in the Numerical Rating Scale (NRS) pain score of ≥ 30% on a 10-point scale.
- Maintenance or improvement in function: defined by key pinch strength, which is ≥ 85% of the subject's pre-operative key pinch strength.
- Safety: success is defined as freedom from:
- Subsequent surgical interventions (SSI) (i.e., reoperation, revision, removal of any study component, or supplemental fixations) on the study carpometacarpal joint, or
- Serious, device- or procedure-related adverse events
Measured: 24 Months/2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start4 Mar 2026
- Primary completionNov 2029 (estimated)
- Study completionFeb 2030 (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
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keri Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA (an IQVIA business)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405983
- Sponsor's protocol ID
- TOUCH® CMC 1 New Enrollment US
- Acronym
- PAS002
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the TOUCH® CMC 1 Prosthesis, Post-Approval Study
- ClinicalTrials.gov ID
- NCT07405983
- Acronym / sponsor ID
- PAS002 / TOUCH® CMC 1 New Enrollment US
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Keri Medical SAIndustry (pharma, biotech, devices)
- Collaborators
- MCRA (an IQVIA business)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Feb 2026 (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 purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population. The device performance in newly enrolled US patients implanted by US surgeons will be compared to device performance observed within the outside the US (OUS) premarket cohort.
Detailed description
TOUCH® CMC 1 (Carpometacarpal) Prosthesis is a cementless, ball-and-socket dual-mobility, total CMC1 joint replacement prosthesis, designed to treat osteoarthritis of the base of the thumb. The TOUCH® CMC 1 Prosthesis was approved by FDA (P240020) on July 10, 2025. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post Approval Study Report per the requirements set forth in the approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOUCH® CMC 1 Prosthesis | – | Device: TOUCH® CMC 1 Prosthesis |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in this study will be recruited from the investigators' standard patient populations. All patients presenting with osteoarthritis of the 1st carpometacarpal joint will be evaluated for study participation based on the inclusion/exclusion criteria. Subjects must meet all of the following inclusion criteria and none of the exclusion criteria. The investigator maintains exclusive responsibility for the inclusion and exclusion of any potential study participant.
Key inclusion criteria (3 listed)
- Patient requiring 1st carpometacarpal (CMC) primary total joint replacement (arthroplasty) to surgically treat symptomatic Eaton-Littler Stage II or III osteoarthritis (OA)
- Adult (≥ 22 years of age) at the time of enrollment
- Willing and able to sign the study Informed Consent
Key exclusion criteria (10 listed)
- Acute or chronic infections, local or systemic
- Muscular, neurological, or vascular severe deficiency affecting the joint
- Inadequate bone quality or quantity preventing the implant fixation
- Bones dimensions incompatible with implant sizes
- Patients who are allergic to the product's materials
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 1 ProsthesisThe TOUCH® CMC 1 Prosthesis is a commercially available thumb joint implant which is made up of three modular components: 1. TOUCH Cup: a stainless steel trapezial implant (cup) with a dual coating of plasma sprayed titanium and hydroxyapatite; TOUCH Cup is available in two options: Spherical and Conical 2. TOUCH Liner and Neck: a junction implant (neck) topped with a liner pre-assembled to stainless steel neck 3. TOUCH Stem: a titanium alloy metacarpal implant (stem) with a dual coating of plasma sprayed titanium and hydroxyapatite | Device | TOUCH® CMC 1 Prosthesis |
Primary outcome
Clinical Composite Success
Time frame: 24 Months/2 Years
1. Improvement of pain: A clinically meaningful improvement in pain during activities defined as a decrease in the Numerical Rating Scale (NRS) pain score of ≥ 30% on a 10-point scale. 2. Maintenance or improvement in function: defined by key pinch strength, which is ≥ 85% of the subject's pre-operative key pinch strength. 3. Safety: success is defined as freedom from: * Subsequent surgical interventions (SSI) (i.e., reoperation, revision, removal of any study component, or supplemental fixations) on the study carpometacarpal joint, or * Serious, device- or procedure-related adverse events
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 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
4 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 and Thumb Carpometacarpal Joint Osteoarthritis, run by Keri Medical SA at 4 sites in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 Deborah Caux (+41 58 611 0062, Deborah.Caux@kerimedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Composite Success (time frame: 24 Months/2 Years). 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 4 Jun 2026.