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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Az Sint-Jan Brugge AV
RECRUITING
Bruges
Contact Information
Primary
Liesbet Noë
liesbet.noe@azsintjan.be
+32 (0)50 45 32 58
Backup
Joke Denolf
joke.denolf@azsintjan.be
+32 (0)50 45 32 58
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2027-10
Participants
Target number of participants: 73
Treatments
Experimental: Device Implantation
Single arm study - Device implanted
Related Therapeutic Areas
Sponsors
Leads: Loci Orthopaedics

This content was sourced from clinicaltrials.gov