A Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Meniscal Repair using T Button R® Meniscus Root Repair Implant
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess functional outcomes of Knee post- meniscal root repair
研究概览
简要总结
This is a single centre prospective study to assess the safety and functional outcomes after arthroscopic meniscal root repair using meniscus root repair implant.
T Button R® Meniscus Root Repair Implant is intended for soft tissue fixation to the bone. It is indicated for surgeries which require soft tissue fixation to Bone specifically for Meniscus root repair. In the current study we plan to assess the safety and functional Outcomes after Arthroscopic Meniscal root repair using T Button R® Meniscus Root Repair Implant via change in IKDC, Lysholm knee score, Tegner activity scale scores, SANE and modified KOOS scale scores. Duration of surgery, failure rate of meniscal root repair and time to recovery will also be done as a part of efficacy assessment. Clinical data collected through this study will be of great benefit to the research field and potentially will be beneficial to society.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male/ female participants between 18 -70 years 2.Participants with meniscal root tear which requires surgical repair 3.Participants who are willing to provide written Informed Consent and comply with study procedures.
排除标准
- •1.Participants with BMI ≥35 kg/m2 2.Participants who had undergone previous surgery in the same or contralateral knee 3.Participants with a history of deep vein thrombosis (DVT) 4.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this study 5.Pregnant and lactating female at the time of screening.
结局指标
主要结局
To assess functional outcomes of Knee post- meniscal root repair
时间窗: Screening/ Baseline, month 1.5, month 6 and month 12
次要结局
- To assess the clinical symptoms and activity(level in the eligible subjects who will undergo)
- To assess the failure rate of meniscal root repair(using T Button R® Meniscus Root Repair)
- To assess change in quality of life in patients(who will undergo meniscal root repair using T)
- To assess recovery period in patients who will(undergo meniscal root repair using T Button R®)
- To assess the duration of surgery with T Button(R® Meniscus Root Repair Implant)
- To assess the overall intraoperative handling of(T Button R® Meniscus Root Repair Implant)
- To assess the safety of the T Button R®(Meniscus Root Repair Implant)
研究者
Dr Neeraj Adkar
Saishree Hospital