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.
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 Type
OBSERVATIONAL
Enrollment
90
Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH PRO
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
Rate of reoperation due to meniscal repair failure at 12 months after surgery
Time frame: 12 months
Rate of reoperation due to meniscal repair failure at 6 months after surgery
Time frame: 6 months
Rate of reoperation due to meniscal repair failure at 24 months after surgery
Time frame: 24 months
Structural integrity of meniscus assessed by MRI
Time frame: 12 and 24 months
Tibiofemoral joint space narrowing assessed by x-ray
Time frame: 12 months
Healing status assessed by in-office needle endoscopy
Time frame: 6 months
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective ScoreOutcomes scores
The International Knee Documentation Committee (IKDC) Subjective score was developed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment, including patients with meniscal injuries. There are three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way (7 items), 2) sports and daily activities (10 items), and 3) current knee function and knee function prior to knee injury (1 item, not included in the score). Responses vary for each item. The possible score ranges from 0-100, where 100 = no limitation with daily or sporting activities and the absence of symptoms.
Time frame: 6, 12, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) Outcomes scores
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Mayo Clinic
Rochester, Minnesota, United States
Ohio State University/Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States
There are five patient-relevant subscales of the KOOS, and each are scored separately: Pain (9 items), Symptoms (7 items), ADL function (17 items), Sport and Recreation Function (5 items), and Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). Each of the 5 scores is calculated as the sum of the items included and then each score is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems as common in orthopedic assessment scales and generic measures. An aggregate score is not calculated so that each of the 5 dimensions can be assess separately.
Time frame: 6, 12, and 24 months
Patient Reported Outcome (PRO):LysholmOutcomes scores
This tool measures the domains of symptoms and complaints and functioning of daily activities. The scale consists of 8 item and is scaled from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning.
Time frame: 6, 12, and 24 months