A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Rotator Cuff Tear Repair Using Knotted UHMWPE Suture Titanium Anchor.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- To evaluate the functional outcomes of the shoulder after Arthroscopic Rotator Cuff Tears Repair from baseline to 24 months post-surgery.
研究概览
简要总结
Surgical techniques have evolved from open to arthroscopic procedures. The development of suitable arthroscopic implants has been critical to the success of arthroscopic tissue repair. The newer implants continue to show promising characteristics. Knotted suture anchors provide the highest attachment strength possible for a wide variety of applications making technically demanding shoulder procedures simpler, safer, and more reproducible. CEPTRE Knotted UHMWPE Suture Titanium Anchor is available in Threaded option made of knotted anchor preloaded on a disposable inserter assembly intended for fixation of suture/ tape to bone. The implant is supplied sterile ready to use. It is intended for soft tissue fixation to the bone. However, there is limited information available on the performance outcome and safety of the product in the real time clinical setting. Therefore, there is a need for conducting prospective post-marketing study to obtain the data on product performance outcome and clinical safety. The objective of the post marketing study is to evaluate the effectiveness and safety in patients who undergo Arthroscopic Rotator Cuff Tears Repair using Knotted UHMWPE Suture Titanium Anchor in 43 eligible subjects as per the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects between 30 to 70 years of age.
- •2.Subjects with rotator cuff tear requiring primary arthroscopic rotator cuff tear repair surgery.
- •3.Subject willing to give written informed consent to participate in the study.
排除标准
- •1.Subjects with BMI ≥35 kg/m2 2.Subjects with a history of any surgery to the same shoulder.
- •3.Subjects with active infection or blood supply limitations.
- •4.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation.
- •6.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period.
- •7.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C ≥ 10).
- •8.Subjects with a history of heavy smoking (> 20 cigarettes/day) within the last 6 months.
- •9.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.
- •10.Subjects who are pregnant or lactating at the time of screening.
结局指标
主要结局
To evaluate the functional outcomes of the shoulder after Arthroscopic Rotator Cuff Tears Repair from baseline to 24 months post-surgery.
时间窗: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery
次要结局
- 1.To evaluate the condition of the shoulder (clinical and functional outcome) from baseline to 24 months post-surgery.(2.To evaluate the quality of life from baseline to 24 months post-surgery.)