Knee tear repair device tested, but study stopped early

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects will be eligible for the study if they meet all of the following criteria at the Baseline Screening: 1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board; 2. 18 to 70 years of age, inclusive at the time of screening; 3. History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way); 4. Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression); 5. If prior ligament reconstruction, the study knee is clinically stable; 6. Meniscal repair to be performed arthroscopically; 7. Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus tear in the symptomatic compartment; 8. Willing and able to comply with all study procedures and visit requirements, including MRIs, X-rays, and Case Report Forms (CRFs) completed by the subject. * Consented subjects may be included in the study only if, upon arthroscopic inspection during the procedure, their meniscal study lesion meets all of the following criteria: 1. Meniscal tear amenable to repair with NOVOSTITCH PRO with or without the use of adjunct devices per the 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). Exclusion Criteria: * 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.