Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears (NCT04361487) | Clinical Trial Compass
TerminatedNot Applicable
Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
Stopped: Slow enrollment resulted in the decision to prematurely terminate the study
United States33 participantsStarted 2020-11-13
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Rate of Freedom From Reoperation at 12 Months After Surgery