Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT04775004
Eligibility Criteria:
Inclusion Criteria
1. Age 16 or older
2. Medial, lateral, vertical longitudinal, oblique, or radial meniscal tear
3. Complex tears may be included at the discretion of the site investigator if patient has one of tear patterns listed in inclusion criteria 2 as the most predominant finding
4. No other concomitant procedure unless one of the following:
* Chondroplasty
* Synovectomy
* Loose body removal
* "Contralateral" menisectomy (i.e. medial meniscus repair with a lateral menisectomy or lateral meniscus repair with a medial menisectomy) would be permitted for inclusion
* Any other procedure that does not include drilling, requires prior approval of the study sponsor for each procedure
Exclusion Criteria
1. Patients requiring cartilage restorative or repair procedures (i.e. OCD fixation, micro-fracture repair, or others)
2. Patients with meniscus root tears
3. Patients undergoing repair for horizontal cleavage tears
4. Kellgren-Lawrence scale 3\>
5. Patients undergoing lateral release
6. Ipsilateral chondral lesion with Outerbridge classification of 3-4
7. Use of prednisone or other steroids, any immunosuppressant, or chemotherapy 1-week before surgery or expected use within six weeks after surgery
8. Cortisone use within the six weeks prior to surgery
9. Utilizing worker's compensation at the time of screening
10. Any previous ligament surgery on the index limb. Any previous meniscal surgery on the index meniscus.
11. Concomitant ligamentous insufficiency
12. Inflammatory rheumatic disease or other rheumatic disease
13. Immune compromised patients (hepatitis, HIV, etc.)
14. Any nicotine based products within the three months prior to surgery (including cigarettes, cigars, vaping, nicotaine patch, etc)
15. History of distal femur, proximal tibia, or patellar fracture that was treated operatively
16. Non English-speaking patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT04775004
Study Brief:
Protocol Section:
NCT04775004