Clinical Analysis of a Novel Flexor Tendon Repair Technique, A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To determine the tendon failure/rupture rate of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care suture repair technique. Also to determine if there are similar or different rates of complications and failures
研究概览
简要总结
The purpose of the research study is to determine the efficacy and efficiency of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care, L-O (Lew-Omar), suture repair technique. The investigators will also determine if there are similar or different rates of complications and failures via both objective and subjective measures.
详细描述
To determine the tendon failure/rupture rate of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care suture repair technique. The investigators will determine if there are similar or different rates of complications and failures (both intraoperatively and at 2-week, 6-week, 3-month, and 6-month post-operative intervals).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study subjects aged 22 and older.
- •Subjects who sustained a Zone 2-5 flexor tendon lacerations
排除标准
- •Subjects under the age of 22 at the time of consent
- •Subjects who sustained a Zone 1 flexor tendon injury
- •Subjects who have had previous surgical procedures on the injured upper extremity.
- •Subjects who have metal allergies
- •Ischemia, blood supply compromise, and/or inadequate wound coverage
- •Prior or current infections at or near the implant site
- •Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period
- •Foreign-body sensitivity
- •The physical contact of the CoNextions TR Tendon Repair System with metal implants made of anything other than the implant grade of stainless steel, such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals
- •Surgical procedures other than for the following indication: digital flexor tendons, digital extensor tendons proximal to the metacarpophalangeal joints (Zones 6-8)
- •Tendon size or surgical site access outside of specified range (Tendon Width (3.0-9.0 mm), Tendon Thickness (1.5-4.0 mm), Minimum Surgical Site Access (20 mm [10mm/side]) for the CoNextions TR Tendon Repair System
结局指标
主要结局
To determine the tendon failure/rupture rate of two tendon repair techniques: the CoNextions tendon repair device vs a standard of care suture repair technique. Also to determine if there are similar or different rates of complications and failures
时间窗: From enrollment to end of postoperative follow up at 6-months.
次要结局
- Visual Analog Pain Scale(From enrollment to end of postoperative follow up at 6-months)
- Range of Motion Assessment(From enrollment to end of postoperative follow up at 6-months)
- Time to Repair(From enrollment to end of postoperative follow up at 6-months)
- Quick DASH Form(From enrollment to end of postoperative follow up at 6-months)
- Grip/Strength Assessment(From enrollment to end of postoperative follow up at 6-months)
- Patient Satisfaction Questionnaire(From enrollment to end of postoperative follow up at 6-months)
- Surgical Time(From enrollment to end of postoperative follow up at 6-months)
研究者
Brett Lewellyn
Chief Hand & Upper Extremity Surgery
Orlando Health, Inc.