A Prospective Post Market Clinical Follow up Study to Evaluate the Safety and Performance of the Meniscus Repair System
Overview
- Phase
- Post Marketing Surveillance
- Status
- Recruiting
- Sponsor
- Auxein Medical Pvt Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. Patient reported outcomes (IKDC and KOOS) will be recorded at pre-operative visit and post-operative follow up visits to evaluate the change.
Overview
Brief Summary
This is a multi-centric prospective post market clinical follow up study. The study is being done to collect more data on safety and performance of the implants used to repair meniscal tear. The specific aim of the study is to assess safety and performance of meniscus repair system. A total of 40 patients will be enrolled in the study. Total duration of study is two years.
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients presenting to orthopaedic OPD or emergency with meniscus tear confirmed through MRI scan.
Exclusion Criteria
- •1 Subjects with a disease entity or condition that could hinder healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder etc.
- •2 Subject with inadequate tissue coverage at the operative sites.
- •3 Patients with concomitant ligamentous injury.
- •4 Patient with history of meniscus surgery.
- •5 Patients with known history of metal allergies.
- •6 Patients with documented mental disorders.
- •7 Patients with life-threatning conditions.
- •8 Subjects who are incarcerated or have pending incarceration.
- •9 Associated other fractures which may interfere the rehabilitation and timely surgical fixation.
Outcomes
Primary Outcomes
1. Patient reported outcomes (IKDC and KOOS) will be recorded at pre-operative visit and post-operative follow up visits to evaluate the change.
Time Frame: 6 week | 3 month | 6 month | 12 month
2. Number of individuals who have returned to pre-injury level of activities of daily living/sports activities will be recorded at each post-operative follow up visit.
Time Frame: 6 week | 3 month | 6 month | 12 month
Secondary Outcomes
- Adverse event (AE), and serious adverse event (SAE), if any will be recorded at each post-operative follow up visit to assess the meniscus repair system.(6 week)
Investigators
Dr Mohd Aslam
Auxein Medical Pvt Ltd