Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears

NCT04361487 | Terminated Results FDA Device

• 1 other identifier: NOVOSTITCH.2019.09
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 6

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.

Conditions

Meniscus Tear; Retention; Meniscus

Keywords

NOVOSTITCH; meniscal; meniscus; repair; knee; horizontal cleavage; complex tear; arthroscopy

Outcome Measures

Primary Outcomes (1)

• Rate of Freedom From Reoperation at 12 Months After Surgery

  Percentage of participants with freedom from reoperation due to meniscal repair failure at 12 months after surgery (i.e., no re-operation required). Freedom from reoperation was defined as no re-operation required due to meniscal repair failure for any reason.

  12 months

Secondary Outcomes (12)

• Rate of Freedom From Reoperation at 6 & 24 Months After Surgery

  6 months, 24 months

• Structural Integrity of Meniscus Assessed by MRI

  Baseline, 12 months, and 24 months

• Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months

  Baseline to 24 months

• Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months

  Baseline to 24 months

• In-Office Needle Endoscopy at 6 Months

  6 months

Study Arms (1)

NOVOSTITCH™ PRO Meniscal Repair System

Participants with horizontal cleavage meniscal tears or complex meniscal tears treated with NOVOSTITCH™ PRO Meniscal Repair System

Device: NOVOSTITCH™ PRO Meniscal Repair System

Interventions

NOVOSTITCH™ PRO Meniscal Repair System DEVICE

Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System

NOVOSTITCH™ PRO Meniscal Repair System

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited at the sports medicine/orthopedic clinic.

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;
• 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:

You may not qualify if:

• 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).
• 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;

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (6)

CAO Research Foundation

Washington D.C., District of Columbia, 20037, United States

Location

Hawai'i Pacific Health / Straub Medical Center

Honolulu, Hawaii, 96813, United States

Location

Rush University Medical Center / Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Overland Park, Kansas, 66211, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Ohio State University/Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

Limitations and Caveats

MRI is known to be suboptimal for meniscal healing assessment (DiBartola et al.).

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

1-800-821-5700

Study Officials

• Karlie Morgan, BS CCRP

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: November 13, 2020
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2024-11

Locations

US (6)