Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears

Exclusion Criteria

• •2. Tear pattern is one of the following:
• •1. Horizontal cleavage tear (HCT), or
• •2. Complex multi-planar tear (combination of at least two of the following tears: horizontal, oblique, radial, vertical).
• •Subjects will be excluded from the study if they meet any of following criteria at the Baseline Screening:
• •1. Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher);
• •2. Body Mass Index (BMI) ≥40 kg/m2;
• •3. Previous surgical meniscal repair or meniscectomy of the study meniscus;
• •4. Unstable knee;
• •5. Clinically significant malalignment of the study knee, and/or requiring osteotomy, and/or correction;
• •6. History of constitutional/systemic inflammatory/arthritic problem or pain condition, history of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, and/or HIV;
• •7. Currently on any immunosuppressive therapy;
• •8. Expected to undergo any other surgical treatment of either knee;
• •9. Previously enrolled in the study (no bilateral knee surgeries);
• •10. Surgical procedures other than those listed in the Indications for Use;
• •11. Patient conditions including insufficient quantity or quality of tissue;
• •12. Insufficient blood supply or previous infections which may hinder the healing process;
• •13. Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to suture implantation;
• •14. Conditions which may limit the patient's ability or willingness to follow postoperative care instructions;
• •15. Any concomitant painful or disabling disease, condition or post-procedure status of either lower extremity that would interfere with evaluation or rehabilitation of the study knee;
• •16. Pregnant or planning to become pregnant in the next 2 years;
• •17. Subject does not understand a language in which the PROs and EQ-5D-5L are available.
• •Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:
• •1. Ramp tears;
• •2. Root or other tear type requiring tibial fixation;
• •3. Tears requiring repair of both meniscus in the study knee;
• •4. Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair;
• •5. Poor meniscal tissue quality such that it will not hold a suture;
• •6. For HCTs:
• •1. Use of any capsular fixation device; OR
• •2. Any portion of the meniscal tear is repaired using a device to place stitches other than NOVOSTITCH PRO, Meniscus Mender II, or Meniscal Stitcher, or FIRSTPASS MINI marketed by Smith + Nephew Inc.;
• •7. For complex tears:
• •a. Any portion of the meniscal tear is repaired using a device to place stitches other than NOVOSTITCH PRO, Meniscus Mender II, Meniscal Stitcher, FIRSTPASS MINI, FAST-FIX 360, or ULTRA FAST-FIX marketed by Smith + Nephew Inc.;
• •8. Clinically significant (zone 1 and/or zone 2) tear in the contralateral compartment to the study meniscus;
• •9. Performance of a significant concomitant procedure (e.g. ACL reconstruction or repair, cartilage repair or restoration) intended as a therapeutic intervention on the study knee;
• •10. Presence of infection;
• •11. Articular cartilage damage in the study knee, defined as Modified Outerbridge Grade III or higher.