CMC Joint ArthritisTHANKS PRONCT06467760
Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant
A study testing InDx CMC Implant in people with CMC Joint Arthritis, run by Loci Orthopaedics at 2 sites in 2 countries.
Trial summary
Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMC Joint Arthritis
- What is being tested?
- InDx CMC Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Mar 2025to 20 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is at least 18 years of age;
- The patient has a confirmed Grade I-III osteoarthritis of the CMC joint on clinical examination and X-ray;
- The patient is eligible for surgical treatment of CMC I arthrosis in the opinion of the investigator.
- The patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the Investigator, for the duration of the study;
- The patient is able to understand the aims and objectives of the trial and is willing to consent;
- The patient is willing and able to return for all study-related follow-up procedures;
- If the patient is female, is either using contraception or is postmenopausal, or male partner is using contraception
Who cannot join
- The patient is suffering from Rheumatoid arthritis in the index hand;
- The patient is suffering from Grade IV osteoarthritis of the CMC joint;
- The patient is suffering post-traumatic arthritis of the CMC joint in the index hand;
- The patient is a pregnant/lactating female (tested as per institutional requirements);
- Active or latent infection, or sepsis;
- Insufficient quantity or quality of bone and/or soft tissue in the index hand;
Show all 14Show fewer
- Metal or polymer material sensitivity;
- Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy;
- Patient with previous thumb surgery in the index hand
- In the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to
- Patients with a diagnosis of concomitant injury that may interfere with healing
- Patients with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease or systemic infection that may make interpretation of the results difficult
- Patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents
- Comorbidity that reduces life expectancy to less than 36 months
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis.
- Conditions
- CMC Joint Arthritis
- Being tested
- InDx CMC Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InDx CMC ImplantDevice
The InDx CMC Implant is a hemiarthroplasty device for the CMC joint which consists of a unified assembly of three components: metacarpal stem, polyethylene liner, and articulating head. Because the device functions as a hemiarthroplasty, it does not link or constrain the CMC joint
| Study group | Role | What they receive |
|---|---|---|
| Device Implantation | Experimental | Single arm study - Device implanted Receives: Device: InDx CMC Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Safety
Determine the incidence of device failure, encompassing mechanical malfunction, structural compromise, loss of functionality due to device failure, or any deviation from the device's intended medical purpose. This will involve monitoring for adverse events requiring total revision surgery, or premature termination of device usage due to device failure.
Measured: 6 Months
Performance
Measure the improvement in hand and wrist functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) score.
Measured: 12 Months
Performance
Measure the improvement in hand and wrist functionality using the Patient-Rated Wrist/Hand Evaluation (PRWHE)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start19 Mar 2025
- Primary completion20 May 2026
- Study completion20 May 2026
Why it stopped: The study was terminated due to sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMC Joint ArthritisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loci Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467760
- Sponsor's protocol ID
- InDx03
- Other IDs
- CIV-24-03-046458
- Acronym
- THANKS PRO
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 2024
- Last updated
- 22 Jul 2026
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant
- ClinicalTrials.gov ID
- NCT06467760
- Acronym / sponsor ID
- THANKS PRO / InDx03
- Conditions
- CMC Joint Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to sponsor decision
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Loci OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 21 Jun 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.
Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Implantation | Experimental | Device: InDx CMC ImplantSingle arm study - Device implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is at least 18 years of age;
- The patient has a confirmed Grade I-III osteoarthritis of the CMC joint on clinical examination and X-ray;
- The patient is eligible for surgical treatment of CMC I arthrosis in the opinion of the investigator.
- The patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the Investigator, for the duration of the study;
- The patient is able to understand the aims and objectives of the trial and is willing to consent;
Key exclusion criteria (14 listed)
- The patient is suffering from Rheumatoid arthritis in the index hand;
- The patient is suffering from Grade IV osteoarthritis of the CMC joint;
- The patient is suffering post-traumatic arthritis of the CMC joint in the index hand;
- The patient is a pregnant/lactating female (tested as per institutional requirements);
- Active or latent infection, or sepsis;
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 |
|---|---|---|
| InDx CMC ImplantThe InDx CMC Implant is a hemiarthroplasty device for the CMC joint which consists of a unified assembly of three components: metacarpal stem, polyethylene liner, and articulating head. Because the device functions as a hemiarthroplasty, it does not link or constrain the CMC joint | Device | Device Implantation |
Primary outcome
Device Safety
Time frame: 6 Months
Determine the incidence of device failure, encompassing mechanical malfunction, structural compromise, loss of functionality due to device failure, or any deviation from the device's intended medical purpose. This will involve monitoring for adverse events requiring total revision surgery, or premature termination of device usage due to device failure.
Performance
Time frame: 12 Months
Measure the improvement in hand and wrist functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) score.
Performance
Time frame: 12 Months
Measure the improvement in hand and wrist functionality using the Patient-Rated Wrist/Hand Evaluation (PRWHE)
Results and safety
The study was stopped early (reason given: The study was terminated due to sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for CMC Joint Arthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Recruiting
Woodcasting Versus Thermoplast Splint in CMC Arthroplasty
Carpometacarpal (CMC) Joint Arthritis
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InDx CMC Implant in people with CMC Joint Arthritis, run by Loci Orthopaedics at 2 sites in 2 countries.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. 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 was stopped early (reason given: The study was terminated due to sponsor decision). Results are not available in the source record.
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?
Device Safety (time frame: 6 Months). The study lists 3 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 22 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.