Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: T Button R® Meniscus Root Repair Implant: T Button R® Meniscus Root Repair Implant is intended for soft tissue fixation to the bone. T Button R® Meniscus Root Repair Implant is indicat
Sponsors
Dr Neeraj Adkar
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess functional outcomes of Knee post- meniscal root repairTimepoint: Screening/ Baseline, month 1.5, month 6 and month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the clinical symptoms and activity level in the eligible subjects who will undergo meniscal root repair.Timepoint: Change in the following will be assessed from Screening/ Baseline (pre-surgery) to 12 months post-operatively using: - - Knee specific symptoms as measured by Lysholm knee score [Time frame: Screening/ Baseline, month 1.5, month 6 and month 12] - Tegner activity scale score [Time frame: Screening/ Baseline, month 1.5, month 6 and month 12] - SANE (Single Assessment Numeric Evaluation) [Time frame: Screening/ Baseline, month 1.5, month 6 and month 12];To assess the failure rate of meniscal root repair using T Button R® Meniscus Root Repair Implant in the eligible subjectsTimepoint: Failure will be assessed on the basis of symptoms requiring revision using Meniscus Root Repair surgery. [Time frame: All visits after surgery including surgery day];To assess change in quality of life in patients who will undergo meniscal root repair using T Button R® Meniscus Root Repair ImplantTimepoint: Quality of life post meniscal root repair surgery via Modified Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Screening/ Baseline, month 12];To assess recovery period in patients who will undergo meniscal root repair using T Button R® Meniscus Root Repair ImplantTimepoint: Time to recovery as measured by mobilization with support of braces/crutches, and mobilization without support of braces/crutches [Time frame: Day 15, month 1.5, month 6 and month 12];To assess the duration of surgery with T Button R® Meniscus Root Repair ImplantTimepoint: Duration of surgery in minutes [Definition: The time interval from skin incision to closure in minutes will be defined as duration of surgery];To assess the overall intraoperative handling of T Button R® Meniscus Root Repair ImplantTimepoint: Overall intraoperative handling with the study product (score based on the ‘Intraoperative assessment of the device by the investigator | — |
Countries
India
Contacts
Public ContactDr Neeraj Adkar
Saishree Hospital
Outcome results
None listed