NCT06196528Unknown不适用
WristArt Total Wrist Arthroplasty Implant First In Human Study
Fibioseq Medical2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年1月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Device Related Serious Adverse events at 6 months post operation
研究概览
简要总结
The WristArt implant will be implanted for the first time in humans' wrists
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
- •Subjects suffering from one the following conditions:
- •Osteoarthritis (OA) of the wrist joint due to various causes (age, trauma, Avascular Necrosis)
- •Rheumatoid arthritis of the wrist joint or other rheumatological diseases which destroy the wrist joint
- •Unrepairable previous intraarticular fractures of the distal radius, scaphoid or lunate bones of the wrist joint (i.e., historical fractures that were failed to fuse surgically)
- •Symptomatic congenital abnormalities around wrist joint such as carpal bones coalition, mild forms of Madelung's deformities etc.
- •Patients who underwent failed proximal row carpectomy, or failed partial carpal bones fusion
- •Patients who's their wrist x-ray shows no damage to the carpal bones that are not fused as part of the surgery
- •Patient Rated Wrist Evaluation Score (PRWE) at baseline is above 70 points out of 100
- •Visual Analog Pain Score (VAS) at baseline is above 70 points out of 100
排除标准
- •Patients younger than 18 years old
- •Patients for whom bone growth did not complete yet
- •Paralytic hand patients
- •Patients with sensitivity to Titanium (ADD/CHANGE MATERIALS AS NEEDED)
- •Cerebral palsy patients with wrist joint contracture and loss of sensation in the hand
- •Low quality of capitate bone and/or excessively short capitate bone (≥50% destruction) due to various causes (AVN, comminuted fracture, lytic lesions, congenital etc.)
研究组 & 干预措施
WristArt implantation
Experimental
干预措施: WristArt implant (Device)
结局指标
主要结局
Number of Device Related Serious Adverse events at 6 months post operation
时间窗: 6 months post operation
Implantation Safety profile at 6 months post operation
Number of cases with Fully and successfully implanted device at the end of surgery per surgeon's reporting and radiological imaging
时间窗: 48 hours post-surgery
Implantation Success profile at the end of surgery
次要结局
- Number of Device Related Serious Adverse events at 24 months post operation(24 months following implantation)
- Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE)(1 month, 3 months, 6 months, 1 year, 2 years)
- Average levels of change in Grip Strength as measured by dynamometer(1 month, 3 months, 6 months, 1 year, 2 years)
- Average Pain Reduction levels according to Visual Analog Pain Score (VAS)(1 month, 3 months, 6 months, 1 year, 2 years)
- Average levels of change in Range of motion as measured by a goniometer(1 month, 3 months, 6 months, 1 year, 2 years)
- Average Surgical Satisfaction Questionnaire (SSQ-8)(1 year)
- Implant loosening rate per radiological measurements(1 month, 3 months, 6 months, 1 year, 2 years)
- Metal Ion Levels in blood at 1 year following surgery(1 year)
- Levels of change in functionality according to quick DASH scores (0 - full function ; 100 - impaired functionality)(1 month, 3 months, 6 months, 1 year, 2 years)
研究者
研究点 (2)
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