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NOVOSTITCH PRO

 

Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears (NOVOSTITCH PRO)

Primary Sponsor: Smith + Nephew, Inc

Principal Investigator: Scott Faucett, MD, MS

Brief 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.

Condition or disease - Meniscus Tear; Meniscus

Intervention/treatment - Device: NOVOSTITCH PRO Meniscal Repair System

Detailed Description: 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.
There are different types of tears in the meniscus. This study includes 2 of the tear types: horizontal cleavage and complex meniscal tears.
Participants will be consented and enrolled in the study prior to knee surgery. Participants will complete surveys before surgery and data obtained from the medical record. In addition, standard of care x-rays and MRIs of the knee will be sent to the study. Participants will have their standard of care surgery to repair the knee using NOVOSTITCH PRO. Images and videos inside the knee during surgery may be sent to the study.
Participants will be followed 2 years after surgery. There are a total of 5 follow-up visits: 2 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Data will be obtained from medical records, surveys, MRIs, and radiographs. Up to 30 participants will have an optional needle endoscopy at the 6-month follow-up visit.

Study Design:

Study Type - Observational

Estimated Enrollment - 90 participants

Observational Model - Cohort

Time Perspective - Prospective

Official Title - Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears

Estimated Study Start Date - October 31, 2020

Estimated Primary Completion Date - January 30, 2023

Estimated Study Completion Date - January 30, 2024