Thumb Hemi-Arthroplasty with Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant (THANKS PRO)

• Conditions: arthrosis of the thumb base joint; Thumb CMC arthrosis; 10023213

• Registration Number: NL-OMON56967
• Lead Sponsor: oci Orthopaedics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

A. The patient is at least 18 years of age;
B. The patient has a confirmed Grade I-III osteoarthritis of the CMC joint on
clinical examination and X-ray;

Exclusion Criteria

A. The patient is suffering from Rheumatoid arthritis;
B. The patient is suffering from Grade IV osteoarthritis of the CMC joint;
C. The patient is suffering post-traumatic arthritis of the CMC joint;
D. The patient is a pregnant/lactating female (tested as per institutional
requirements);
E. Active or latent infection, or sepsis;
F. Insufficient quantity or quality of bone and/or soft tissue;
G. Metal or polymer material sensitivity;
H. Muscular imbalance, peripheral vascular disease that prohibits adequate
healing, or a a poor soft-tissue envelope in the surgical field, absence of
musculoligamentous supporting structures, or peripheral neuropathy;
I. Patient with previous thumb surgery
J. In the opinion of the investigator, any medical condition that makes the
subject unsuitable for inclusion in the study, including, but not limited to
a. Patients with a diagnosis of concomitant injury that may interfere with
healing
b. 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
K. Patients who have undergone systemic administration within 30 days prior to
implantation of any type of corticosteroid, antineoplastic, immunostimulating,
or immunosuppressive agents;
L. Comorbidity that reduces life expectancy to less than 36 months;

Study & Design

• Study Type: Interventional
• Study Design: Not specified