A Single Centre Study to Assess the Safety and Functional Outcomes after Arthroscopic Meniscal Repair using T Button R® Meniscus Root Repair Implant
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Dr Neeraj Adkar
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess functional outcomes of Knee post- meniscal root repair
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To assess functional outcomes of Knee post- meniscal root repair
Time Frame: Screening/ Baseline, month 1.5, month 6 and month 12
Secondary Outcomes
- 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)
Investigators
Dr Neeraj Adkar
Saishree Hospital