A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Bankarts Repair using Knotted UHMWPE Suture Anchor.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- To assess the shoulder function and stability post Bankarts repair using Knotted UHMWPE Suture Anchor
研究概览
简要总结
Arthroscopic procedurestheoretically offer advantages of the decreased loss of motion, decreasedmorbidity, avoidance of subscapularis tenotomy, and the capacity to addressconcomitant intra-articular pathology, studies have shown a faster return to preoperativemuscle strength. StativKnotted UHMWPE Suture Anchor also referred as All suture anchor is made up ofNon-Absorbable Ultra-high-molecular-weight polyethylene (UHMWPE) braided suture,a fixation device intended to provide secure fixation of soft tissue to bone. However,there is limited information available on the performance outcome and safety ofthe product in the real time clinical setting. Therefore, there is a need forconducting prospective post-marketing study to obtain the data on productperformance outcome and clinical safety. The objective of the study is toevaluate the effectiveness and safety in patients who undergone arthroscopicBankarts Repair using Knotted UHMWPE Suture Anchor in 44 eligible subjects asper 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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects between 18 to 40 years of age.
- •2.Subjects with Bankarts lesion requiring primary Arthroscopic Bankarts repair surgery.
- •3.Subjects willing to give written informed consent to participate in the study.
排除标准
- •1.Subjects with BMI ≥35 kg/m
- •2.Subjects with history of any surgery to the same shoulder.
- •3.Subjects with active infection or blood supply limitations.
- •4.Subjects with pathological conditions of bone or soft tissue that would impair secure fixation.
- •5.Subjects with known hypersensitivity to UHMWPE 6.Subjects with conditions, which would limit the subjects ability or willingness to restrict activities or follow directions during the healing period.
- •Infections, Regular use of Corticosteroids, Diabetes – HbA1C ≥ 10).
- •8.Subjects with 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 assess the shoulder function and stability post Bankarts repair using Knotted UHMWPE Suture Anchor
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 assess the functional outcomes post Bankarts repair using Knotted UHMWPE Suture Anchor(2.To assess the instability after Bankart’s repair using Knotted UHMWPE Suture Anchor)