Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant

NCT ID: NCT06467760

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2027-10-31

Brief 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.

Conditions

CMC Joint Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Implantation

Single arm study - Device implanted

Group Type: EXPERIMENTAL

InDx CMC Implant

Intervention Type: DEVICE

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

Interventions

InDx CMC Implant

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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;
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loci Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Az Sint-Jan Brugge AV

Bruges, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Liesbet Noë

Role: CONTACT

liesbet.noe@azsintjan.be

+32 (0)50 45 32 58

Joke Denolf

Role: CONTACT

joke.denolf@azsintjan.be

+32 (0)50 45 32 58

Facility Contacts

Liesbet Noë

Role: primary

liesbet.noe@azsintjan.be

+32 (0)50 45 32 58

Joke Denolf

Role: backup

joke.denolf@azsintjan.be

+32 (0)50 45 32 58

Other Identifiers

InDx03

Identifier Type: -

Identifier Source: org_study_id