Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears

Stopped early

Conditions studied: Meniscus Tear, Retention; Meniscus

In brief

The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.

Key facts

Study ID

NCT04361487

Run by

Smith & Nephew, Inc.

People needed

33

Starts

2020-11-13

Expected to finish

2024-04-25

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be eligible for the study if they meet all of the following criteria at the Baseline Screening:
• Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board;
• 18 to 70 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;
• Meniscal repair to be performed arthroscopically;
• Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus tear in the symptomatic compartment;
• 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:
• Meniscal tear amenable to repair with NOVOSTITCH PRO with or without the use of adjunct devices per the exclusion criteria;
• Tear pattern is one of the following:
• Horizontal cleavage tear (HCT), or
• Complex multi-planar tear (combination of at least two of the following tears: horizontal, oblique, radial, vertical).

You may not qualify if…

• Subjects will be excluded from the study if they meet any of following criteria at the Baseline Screening:
• Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher);
• Body Mass Index (BMI) ≥40 kg/m2;
• Previous surgical meniscal repair or meniscectomy of the study meniscus;
• Unstable knee;
• Clinically significant malalignment of the study knee, and/or requiring osteotomy, and/or correction;
• 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;
• Currently on any immunosuppressive therapy;
• Expected to undergo any other surgical treatment of either knee;
• Previously enrolled in the study (no bilateral knee surgeries);
• Surgical procedures other than those listed in the Indications for Use;
• Patient conditions including insufficient quantity or quality of tissue;
• Insufficient blood supply or previous infections which may hinder the healing process;
• Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to suture implantation;
• Conditions which may limit the patient's ability or willingness to follow postoperative care instructions;
• 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;
• 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:
• Ramp tears;
• Root or other tear type requiring tibial fixation;
• Tears requiring repair of both meniscus in the study knee;
• 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;
• For HCTs:

Where it is running

• CAO Research Foundation — Washington D.C., District of Columbia, United States
• Hawai'i Pacific Health / Straub Medical Center — Honolulu, Hawaii, United States
• Rush University Medical Center / Midwest Orthopaedics at Rush — Chicago, Illinois, United States
• University of Kansas Medical Center — Overland Park, Kansas, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Ohio State University/Jameson Crane Sports Medicine Institute — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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