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

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.

Study Overview

• Status: Terminated
• Conditions: Meniscus Tear; Retention; 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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • CAO Research Foundation
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawai'i Pacific Health / Straub Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center / Midwest Orthopaedics at Rush
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • University of Kansas Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Columbus, Ohio, United States, 43202
      • Ohio State University/Jameson Crane Sports Medicine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Subjects will be eligible for the study if they meet all of the following criteria at the Baseline Screening:

  1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board;
  2. 18 to 70 years of age, inclusive at the time of screening;
  3. History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way);
  4. Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression);
  5. If prior ligament reconstruction, the study knee is clinically stable;
  6. Meniscal repair to be performed arthroscopically;
  7. Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus tear in the symptomatic compartment;
  8. 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:

  1. Meniscal tear amenable to repair with NOVOSTITCH PRO with or without the use of adjunct devices per the exclusion criteria;

  2. Tear pattern is one of the following:

     1. Horizontal cleavage tear (HCT), or
     2. Complex multi-planar tear (combination of at least two of the following tears: horizontal, oblique, radial, vertical).

Exclusion Criteria:

• Subjects will be excluded from the study if they meet any of following criteria at the Baseline Screening:

  1. Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher);
  2. Body Mass Index (BMI) ≥40 kg/m2;
  3. Previous surgical meniscal repair or meniscectomy of the study meniscus;
  4. Unstable knee;
  5. Clinically significant malalignment of the study knee, and/or requiring osteotomy, and/or correction;
  6. 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;
  7. Currently on any immunosuppressive therapy;
  8. Expected to undergo any other surgical treatment of either knee;
  9. Previously enrolled in the study (no bilateral knee surgeries);
  10. Surgical procedures other than those listed in the Indications for Use;
  11. Patient conditions including insufficient quantity or quality of tissue;
  12. Insufficient blood supply or previous infections which may hinder the healing process;
  13. Foreign body sensitivity. If material sensitivity is suspected, testing should be completed prior to suture implantation;
  14. Conditions which may limit the patient's ability or willingness to follow postoperative care instructions;
  15. 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;
  16. Pregnant or planning to become pregnant in the next 2 years;
  17. 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:

  1. Ramp tears;
  2. Root or other tear type requiring tibial fixation;
  3. Tears requiring repair of both meniscus in the study knee;
  4. Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair;
  5. Poor meniscal tissue quality such that it will not hold a suture;

  6. For HCTs:

     1. Use of any capsular fixation device; OR
     2. Any portion of the meniscal tear is repaired using a device to place stitches other than NOVOSTITCH PRO, Meniscus Mender II, or Meniscal Stitcher, or FIRSTPASS MINI marketed by Smith + Nephew Inc.;

  7. For complex tears:

     a. Any portion of the meniscal tear is repaired using a device to place stitches other than NOVOSTITCH PRO, Meniscus Mender II, Meniscal Stitcher, FIRSTPASS MINI, FAST-FIX 360, or ULTRA FAST-FIX marketed by Smith + Nephew Inc.;

  8. Clinically significant (zone 1 and/or zone 2) tear in the contralateral compartment to the study meniscus;
  9. Performance of a significant concomitant procedure (e.g. ACL reconstruction or repair, cartilage repair or restoration) intended as a therapeutic intervention on the study knee;
  10. Presence of infection;
  11. Articular cartilage damage in the study knee, defined as Modified Outerbridge Grade III or higher.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Freedom From Reoperation at 6 & 24 Months After Surgery	Percentage of participants with freedom from reoperation due to meniscal repair failure at 6 months & 24 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.	6 months, 24 months
Structural Integrity of Meniscus Assessed by MRI	Structural integrity of the meniscus was identified using Magnetic Resonance Imaging (MRI) by the results of the Meniscal Signal Index Meniscus grading. Participants were categorized using the following grading: Grade 0: Low signal intensity indicative of a normal meniscus.; Grade 1: Irregularly marginated elevated signal with globular shape, suggestive of early meniscal degeneration.; Grade 2: Linear elevated signal (i.e. confirmed fluid signal) not extending into the tibial or femoral articular surface.; Grade 3: Linear elevated signal (i.e. confirmed fluid signal) extending into the tibial or femoral articular surface, suggestive of a tear	Baseline, 12 months, and 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in Medial Compartment From Baseline to 24 Months	Change in Tibiofemoral Joint Space Narrowing (JSN) in the medial compartment was measured in millimeters (mm) as assessed by x-rays.	Baseline to 24 months
Change in Tibiofemoral Joint Space Narrowing (JSN) in Lateral Compartment From Baseline to 24 Months	Change in Tibiofemoral Joint Space Narrowing (JSN) in the lateral compartment was measured in millimeters (mm) as assessed by x-rays.	Baseline to 24 months
In-Office Needle Endoscopy at 6 Months	In-office needle endoscopy is a minimally invasive procedure in which a needle-sized camera is inserted into tissue for observation and/or biopsy purposes. For this study, a needle-sized endoscopy was inserted to record video and images of the meniscal repair site and visually assess healing. Healing by participant was categorized as: Healed; Incompletely Healed; Failure	6 months
Patient Reported Outcome (PRO): International Knee Documentation Committee (IKDC) Subjective Score	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. Possible scores range from 0-100, where 100 indicated the highest level of function and lowest level of symptoms (i.e., better outcome), and 0 indicated the lowest level of function or highest level of symptoms (i.e., worse outcome).	Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Symptoms Score	The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are 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 for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).	Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain Score	The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are 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 for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).	Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Activities of Daily Life Score	The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are 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 for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).	Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Sport Score	The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are 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 for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).	Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Knee Injury and Osteoarthritis Outcome Score (KOOS) - Quality of Life Score	The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five patient-relevant subscales with each scored separately. The subscales are 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 for each subscale with 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 (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).	Baseline, 6 months, 12 months, and 24 months
Patient Reported Outcome (PRO): Lysholm Knee Scoring Scale Score	The Lysholm Knee Scoring Scale measures the participant's symptoms and functioning of daily activities by assessing 8 items: limping, using cane or crutches, locking sensation in the knee, giving way sensation from the knee, pain, swelling, climbing stairs, and squatting. The scale is scored on a scale from 0 to 100, with a higher score indicating fewer symptoms and higher level of functioning (i.e., a better outcome).	Baseline, 6 months, 12 months, and 24 months

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Karlie Morgan, BS CCRP, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: knee; arthroscopy; meniscus; repair; meniscal; NOVOSTITCH; horizontal cleavage; complex tear
• Other Study ID Numbers: NOVOSTITCH.2019.09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No