A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Procedure using Fixed Loop UHMWPE Suture Titanium Button and Titanium Interference Screw.
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
- 3
- 主要终点
- To evaluate the functional outcomes of the knee after ACL Reconstruction surgery from baseline to 24 months post-surgery
研究概览
简要总结
Arthroscopy implants are used for the fixation of the ACLgrafts at the femoral and tibial sides. Numerous grafts in terms of fixedsuture button, adjustable loop suture button, and interference screws made upof multiple materials will be used for the fixation. However, there is limitedinformation available on the performance outcome and safety of the products inthe real time clinical setting in India. 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 arthroscopicACL reconstruction using Fixed Loop UHMWPE Suture Titanium Button and TitaniumInterference Screw 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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects between 18 to 45 years of age.
- •2.Subjects with ACL injury with or without associated meniscus injuries requiring primary ACL reconstruction surgery.
- •3.Subject willing to give written informed consent to participate in the study.
排除标准
- •1.Subjects with Posterior Cruciate Ligament injury, and/or Collateral ligament injury.
- •2.Subjects with known hypersensitivity to titanium and/or UHMWPE suture.
- •3.Subjects with BMI ≥35 kg/m2 4.Subjects with a history of previous knee surgery 5.Subjects with the insufficient quantity or skeletally immature bone.
- •6.Subjects with active infection or blood supply limitations.
- •7.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation.
- •8.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period.
- •9.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C ≥ 10).
- •10.Subjects with a history of heavy smoking (> 20 cigarettes/day) within the last 6 months.
- •11.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.
- •12.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 knee after ACL Reconstruction surgery from baseline to 24 months post-surgery
时间窗: Screening, 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 knee (clinical and functional outcome) from baseline to 24 months post-surgery(2. To evaluate the knee stability from baseline to 24 months post-surgery)