NCT06467760终止不适用
Thumb Hemi-Arthroplasty With Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant
Loci Orthopaedics3 个研究点 分布在 2 个国家目标入组 14 人开始时间: 2025年3月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Device Safety
研究概览
简要总结
Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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/lactating female (tested as per institutional requirements);
- •Active or latent infection, or sepsis;
- •Insufficient quantity or quality of bone and/or soft tissue in the index hand;
- •Metal or polymer material sensitivity;
- •Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy;
- •Patient with previous thumb surgery in the index hand
- •In the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to
- •Patients with a diagnosis of concomitant injury that may interfere with healing
- •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
- •Patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents
- •Comorbidity that reduces life expectancy to less than 36 months
研究组 & 干预措施
Device Implantation
Experimental
Single arm study - Device implanted
干预措施: InDx CMC Implant (Device)
结局指标
主要结局
Device Safety
时间窗: 6 Months
Determine the incidence of device failure, encompassing mechanical malfunction, structural compromise, loss of functionality due to device failure, or any deviation from the device's intended medical purpose. This will involve monitoring for adverse events requiring total revision surgery, or premature termination of device usage due to device failure.
Performance
时间窗: 12 Months
Measure the improvement in hand and wrist functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) score.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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