Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial
- Conditions
- Osteoarthritis Thumb Base Joint
- Registration Number
- NCT05644132
- Lead Sponsor
- Loci Orthopaedics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - The patient is at least 18 years of age;<br><br> - The patient has a confirmed Grade 1-111 osteoarthritis of the CMG joint on clinical<br> examination and X-ray;<br><br> - The patient agrees to abstain from enrolment in any other clinical trials that will<br> conflict or interfere with the interpretation of the results of this study, in the<br> opinion of the Investigator, for the duration of the study;<br><br> - The patient is able to understand the aims and objectives of the trial and is<br> willing to consent;<br><br> - Be willing and able to return for all study-related follow-up procedures;<br><br> - If female, is either using contraception or is postmenopausal, or male partner is<br> using contraception; and<br><br> - Have been informed of the nature of the study, agreeing to its requirements, and<br> have signed the informed consent approved by the institutional review board/ethics<br> committee.<br><br>Exclusion Criteria:<br><br> - The patient is <18 years of age;<br><br> - The patient is suffering from Rheumatoid Arthritis;<br><br> - The patient is suffering from Grade IV osteoarthritis of the CMG joint;<br><br> - The patient is suffering post-traumatic arthritis of the CMG joint;<br><br> - The patient is a pregnant/lactating female (tested as per institutional<br> requirements);<br><br> - Active or latent infection, or sepsis;<br><br> - Insufficient quantity or quality of bone and/or soft tissue;<br><br> - Metal or polymer material sensitivity;<br><br> - Patients who are unwilling or incapable of following postoperative care instructions<br> or protocol requirements;<br><br> - Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or<br> a poor soft-tissue envelope in the surgical field, absence of musculoligamentous<br> supporting structures, or peripheral neuropathy;<br><br> - Patient with previous thumb surgery;<br><br> - In the opinion of the investigator, any medical condition that makes the subject<br> unsuitable for inclusion in the study, including, but not limited to, subjects with<br> a diagnosis of concomitant injury that may interfere with healing; subjects with<br> clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune,<br> or any systemic disease or systemic infection that may make interpretation of the<br> results difficult; subjects who have undergone systemic administration within 30<br> days prior to implantation of any type of corticosteroid, antineoplastic,<br> immunostimulating, or immunosuppressive agents;<br><br> - Comorbidity that reduces life expectancy to less than 36 months.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device Survival;Device Survival;Device Survival;Device Survival;Device Survival;DASH Scores (Scale: 0-100);DASH Scores (Scale: 0-100);DASH Scores (Scale: 0-100)
- Secondary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) Pain Score;Visual Analogue Scale (VAS) Pain Score;Visual Analogue Scale (VAS) Pain Score;Visual Analogue Scale (VAS) Pain Score;Grip and pinch strength measurements;Grip and pinch strength measurements;Grip and pinch strength measurements;Grip and pinch strength measurements;Kapandji Score;Kapandji Score;Kapandji Score;Kapandji Score