Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06467760

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

Led by Loci Orthopaedics · Updated on 2025-09-03

73

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 conflict or interfere with this study's results
  • 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 female, the patient is either using contraception, postmenopausal, or has a male partner using contraception
Not Eligible

You will not qualify if you...

  • 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 or lactating female
  • The patient has active or latent infection, or sepsis
  • The patient has insufficient quantity or quality of bone and/or soft tissue in the index hand
  • The patient has metal or polymer material sensitivity
  • The patient has muscular imbalance, peripheral vascular disease that prohibits adequate healing, poor soft-tissue envelope, absence of musculoligamentous supporting structures, or peripheral neuropathy
  • The patient has had previous thumb surgery in the index hand
  • The patient has any medical condition deemed unsuitable by the investigator, including injury interfering with healing or significant systemic disease or infection
  • The patient has undergone systemic corticosteroid, antineoplastic, immunostimulating, or immunosuppressive therapy within 30 days prior to implantation
  • The patient has comorbidity reducing life expectancy to less than 36 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Az Sint-Jan Brugge AV

Bruges, Belgium, 8000

Actively Recruiting

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Research Team

L

Liesbet Noë

CONTACT

J

Joke Denolf

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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