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

oci Orthopaedics Ltd0 个研究点目标入组 26 人开始时间: 待定最近更新: 2024年9月2日

试验速览

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•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
•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;

发起方

oci Orthopaedics Ltd