NCT03622372Unknown3 期
Pivotal, Randomised, Controlled Trial to Evaluate the Safety and Effectiveness of the CoNextions TR Implant System for Zone 2 Flexor Tendon Repair
CoNextions Medical4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年6月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Rate of tendon re-rupture
研究概览
简要总结
Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the Occupational Therapist performing the majority of the outcome assessments will be masked to the treatment until the 12 week post-operative visit.
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
- •At least 18 years of age
- •Willing and able to provide a signed and dated informed consent form
- •Stated willingness to comply with all study procedures
- •Available for the duration of the study
- •Have one or two fully lacerated digital FDP tendon(s), with or without a concomitant injury of the flexor digitorum superficialis, in Zone 2 of the index, middle, ring, or small finger
- •Tendon laceration occurred within the previous 14 days
排除标准
- •Pregnant or planning to become pregnant during the follow-up period
- •Autoimmune disorder(s)
- •Type 1 diabetes mellitus or clinical history of poorly controlled Type 2 diabetes mellitus
- •Lack of proper cutaneous coverage at repair site
- •Concomitant fracture
- •Amputated digit(s)
- •Arthritis of the hand
- •Prior hand trauma with residual impact to function
- •Congenital hand defect
- •Conditions that would affect comparative measurements in the uninjured hand
- •Tendon laceration caused by a crush injury
- •Prior sensory impairment in digits of either hand. Note: Participants with nerve injuries associated with the trauma causing the current flexor tendon injury are eligible for enrollment
- •Vascular injuries that require revascularisation procedures
- •Ischemia and/or blood supply compromise
- •Prior or current infections at or near the intended implant site
- •Active sepsis, MRSA, or other conditions that may prevent healing
- •History of foreign-body sensitivity to 316 L Stainless Steel or UHMWPE
- •Implantation of CoNextionsTR Implant would result in physical contact with other metal implants made of material other than implant grade stainless steel such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals
- •Any condition(s) which, in the opinion of the investigator, may impact the participant's ability to properly follow-up or otherwise be at-risk for following protocol instructions
- •Currently participating in another clinical/device trial
- •The following criteria, determined during the surgical procedure, will also cause an individual to be excluded from the study:
- •Surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site
- •Injured tendon is outside of the width range (3.0-7.0 mm) and thickness range (1.5-4.0 mm) specified for the CoNextionsTR Implant System.
结局指标
主要结局
Rate of tendon re-rupture
时间窗: 24 weeks
Primary Safety Endpoint
Mobility of the affected digits using Strickland's Revised Score
时间窗: 24 weeks
Primary Effectiveness Endpoint-Strickland's Revised Score provides a descriptive measure of the mobility of digits. Range of motion measurements taken on the studied digits are used to generate a score on a 0 (least mobile) to 100 (most mobile) with outcomes being classified as: excellent (75-100%), good (50-784%), fair (25-49%), or poor (\<25%).
次要结局
- Visual Analog Score (VAS) for Pain Assessment (0-10 cm scale)(24 weeks)
- Surgical Site Infection(24 weeks)
- Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Questionnaire(24 weeks)
- Grip Strength measured using a dynamometer with values for the affected hand being calculated as a percentage of the grip strength of the unaffected hand(24 weeks)
- Tip pinch strength measured with a pinch gauge with values for the affected fingers calculated as a percentage of the tip pinch strength for corresponding fingers on the unaffected hand(24 weeks)
研究者
研究点 (4)
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