Study of Suture Repair of Torn Meniscus in the Knee (STITCH)

This is an interventional treatment trial for Meniscal Tear focused on measuring meniscal, meniscus, repair, knee, arthroscopy knee, horizontal Read More

Screening Inclusion Criteria:

Subjects of either gender may be eligible for inclusion in the study only if they meet all of the following criteria:

• Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board
• 18 to 60 years of age, inclusive at the time of screening;
• History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way);
• Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression);
• If prior ligament reconstruction, the study knee is clinically stable;
• Preoperative MRI evidence within 6 months consistent with a horizontal/radial/oblique meniscus tear in the symptomatic compartment

Arthroscopy Inclusion Criteria:

Consented subjects may be included in the study only if, upon arthroscopic inspection, their meniscal study lesion meets all of the following criteria established by the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) (see Appendix 1):

• Zone location: circumferential location of tear includes locations within 10mm of the peripheral rim of the meniscus;
• Radial location: any location from anterior to posterior;
• Tear pattern: primarily horizontal or oblique in orientation (not to exceed 45 degrees from horizontal);
• Compartment: either lateral or medial, but not both;
• Opposite compartment meniscal tear (if present) limited to the central portion (i.e., Zone 3/"white zone");
• Tear amenable to repair with all suture-based techniques.

Screening Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

• Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher [See Appendix 4]);
• Body Mass Index (BMI) ≥35 kg/m2;
• Previous meniscal repair or meniscectomy of the study meniscus;
• Unstable knee;
• Malalignment (> 5 degrees) of the study knee, based on X-ray within 6 months requiring osteotomy and/or requiring correction;
• History of constitutional/systemic inflammatory/arthritic problem or pain condition, history of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, HIV, drug/alcohol abuse, tobacco use, cancer;
• Expected to undergo any other primary treatment of the knee;
• 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.
• Pregnant or planning to become pregnant in the next 2 years.

Arthroscopy Exclusion Criteria:

Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:

• Tear pattern: primarily vertical longitudinal in orientation;
• Partial meniscectomy of any portion of the study meniscus extends beyond the central portion (i.e., Zone 3/"white zone");
• Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair;
• Poor meniscal tissue quality such that it will not hold a suture;
• Any portion of the meniscus repair that, in the opinion of the Investigator, is best treated using an implant other than suture;
• Bicompartmental Zone 1/"red zone" and/or Zone 2/"red-white zone" meniscal tears;
• Performance of a significant concomitant procedure intended as a therapeutic intervention on the study knee;
• Arthritis in the surgical knee (International Cartilage Research Society [ICRS] Grade 3b or higher or Modified Outerbridge Grade III or higher)