Health Condition 1: M232- Derangement of meniscus due to oldtear or injury
Conditions
Interventions
Intervention1: Meniscus suturing: Follow up at following time points
6 week
3 month
6 month
12 month
Control Intervention1: None: NA
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting to orthopaedic OPD or emergency with meniscus tear confirmed through MRI scan.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient reported outcomes (IKDC and KOOS) will be recorded at pre-operative visit and post-operative follow up visits to evaluate the change. 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. Timepoint: 6 week 3 month 6 month 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 6 week 3 month 6 month 12 month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed