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Study of Suture Repair of Torn Meniscus in the Knee (STITCH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Ceterix Orthopaedics, Inc.
Sponsor:
Information provided by (Responsible Party):
Ceterix Orthopaedics, Inc.
ClinicalTrials.gov Identifier:
NCT02237001
First received: September 6, 2014
Last updated: February 15, 2017
Last verified: February 2017
  Purpose
Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the repair, by assessing the re-operation rate, and by assessing improvements in knee pain and knee function.

Condition Intervention
Meniscal Tear
Meniscus Tear
Device: Suture-based meniscal repair

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)

Resource links provided by NLM:


Further study details as provided by Ceterix Orthopaedics, Inc.:

Primary Outcome Measures:
  • Freedom from reoperation of the index meniscus repair site [ Time Frame: 2 years ]
    Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.


Secondary Outcome Measures:
  • Assess improvements in knee pain and function [ Time Frame: 3 months, 6 months, 1 year, and 2 years ]
    Change in knee pain and function will be measured by completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation), Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm Knee Questionnaire and Tenger Activity Scale from Baseline and specified intervals.


Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Suture-based meniscal repair
Device: Suture-based meniscal repair
Suture-based meniscal repair

Detailed Description:

Potential subjects will undergo Screening for eligibility based on Inclusion/Exclusion criteria. Screening will include an x-ray of the injured knee and evaluation of an MRI of the injured knee within 6 months prior to the scheduled procedure. During the procedure, the meniscal tear will be evaluated by arthroscopy to determine if the tear meets study requirements. If the meniscal tear is determined to meet inclusion/exclusion criteria, the subject will be considered enrolled. If any inclusion/exclusion criteria is not met, the subject will be considered a screen failure and will not be enrolled. For enrolled subjects, specific information regarding the repair and repair technique will be collected during the procedure, including still and video images.

Subjects will be contacted 7-15 days post-procedure for safety follow-up. Subjects will return for follow-up visits at approximately post-procedure Days 90, 185, 365 and 730. Identical questionnaires will be completed at each visit to assess knee pain and knee function. Safety information will be collected at each post-procedure visit. Additionally, an in-office arthroscopy of the treated knee will be performed at participating sites at Day 185, an MRI of the treated knee will be performed at Day 365 and an X-ray of the treated knee will be performed at Day 730. The patient will exit the study at the Day 730 visit.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Screening Inclusion Criteria:

Subjects of either gender may be eligible for inclusion in the study only if they meet all of the following criteria:

  • Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board
  • 18 to 60 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;
  • Preoperative MRI evidence within 6 months consistent with a horizontal/radial/oblique meniscus tear in the symptomatic compartment

Arthroscopy Inclusion Criteria:

Consented subjects may be included in the study only if, upon arthroscopic inspection, their meniscal study lesion meets all of the following criteria established by the International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) (see Appendix 1):

  • Zone location: circumferential location of tear includes locations within 10mm of the peripheral rim of the meniscus;
  • Radial location: any location from anterior to posterior;
  • Tear pattern: primarily horizontal or oblique in orientation (not to exceed 45 degrees from horizontal);
  • Compartment: either lateral or medial, but not both;
  • Opposite compartment meniscal tear (if present) limited to the central portion (i.e., Zone 3/"white zone");
  • Tear amenable to repair with all suture-based techniques.

Screening Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

  • Arthritis in the study knee (Kellgren-Lawrence Grade 3 or higher [See Appendix 4]);
  • Body Mass Index (BMI) ≥35 kg/m2;
  • Previous meniscal repair or meniscectomy of the study meniscus;
  • Unstable knee;
  • Malalignment (> 5 degrees) of the study knee, based on X-ray within 6 months requiring osteotomy and/or requiring correction;
  • History of constitutional/systemic inflammatory/arthritic problem or pain condition, history of knee infection, vascular condition of legs, benign neoplasms of knee, hepatitis, HIV, drug/alcohol abuse, tobacco use, cancer;
  • Expected to undergo any other primary treatment of the knee;
  • 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.
  • Pregnant or planning to become pregnant in the next 2 years.

Arthroscopy Exclusion Criteria:

Subjects will be excluded from the study if their study meniscus lesion meets any of the following criteria at arthroscopy:

  • Tear pattern: primarily vertical longitudinal in orientation;
  • Partial meniscectomy of any portion of the study meniscus extends beyond the central portion (i.e., Zone 3/"white zone");
  • Intact or partially intact meniscus tear that, in the opinion of the Investigator, does not require repair;
  • Poor meniscal tissue quality such that it will not hold a suture;
  • Any portion of the meniscus repair that, in the opinion of the Investigator, is best treated using an implant other than suture;
  • Bicompartmental Zone 1/"red zone" and/or Zone 2/"red-white zone" meniscal tears;
  • Performance of a significant concomitant procedure intended as a therapeutic intervention on the study knee;
  • Arthritis in the surgical knee (International Cartilage Research Society [ICRS] Grade 3b or higher or Modified Outerbridge Grade III or higher)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02237001

Contacts
Contact: Christopher Pfaff, MS 650-316-8660 cpfaff@ceterix.com
Contact: Steven M Scott, RN 615-473-5524 sscott@researchworx.net

Locations
United States, California
CORE Orthopaedic Medical Center Recruiting
Encinitas, California, United States, 92024
Contact: Farouk Awad    760-943-6710 ext 162    fawad@coreorthopaedic.com   
Principal Investigator: Greg J Loren, M.D.         
Memorial Orthopedic Surgical Group Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Carlos Edwards    562-424-6666    carlosjedwards@gmail.com   
Principal Investigator: Peter R Kurzweil, MD         
United States, District of Columbia
The Orthopaedic Center, PA Recruiting
Washington, District of Columbia, United States, 20038
Contact: Chrissette Andrews    202-770-1447    candrews@theorthocentermd.com   
Principal Investigator: Scott C Faucett, MD, MS         
United States, Florida
Andrews Research and Education Foundation, INC Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Laura Schubert, RN    850-916-8590    laura.schubert@andrewsref.org   
Principal Investigator: Adam Anz, M.D.         
United States, Indiana
OrthoIndy South Recruiting
Greenwood, Indiana, United States, 46143
Contact: Vicki R Snodgrass-Miller, BA    317-884-5230    vsmiller@orthoindy.com   
Principal Investigator: Jack Farr, M.D.         
Sub-Investigator: Matthew Lavery, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer L Krogman    507-538-3562    krogman.jennifer@mayo.edu   
Principal Investigator: Aaron Krych, M.D.         
Sub-Investigator: Diane Dahm, M.D.         
Sub-Investigator: Michael Stuart, M.D.         
Sub-Investigator: Bruce Levy, M.D.         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Courtney Webb    614-293-2410    Courtney.Webb@osumc.edudu   
Contact: Angela Pedroza       Angela.Pedroza@osumc.edu   
Principal Investigator: David Flanigan, M.D.         
Sub-Investigator: Christopher Kaeding, M.D.         
Sub-Investigator: Robert Magnussen, M.D.         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kaitlyn Shank    434-243-5653    KCG4HF@hscmail.mcc.virginia.edu   
Principal Investigator: F. W Gwathmey, M.D.         
Sub-Investigator: Mark D Miller, M.D.         
Sub-Investigator: Eric W Carson, M.D.         
Sub-Investigator: David R Diduch, M.D.         
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
Contact: Ashley Zelaski    540-536-7542    azelaski@valleyhealthlink.com   
Principal Investigator: James Larson, MD         
Sponsors and Collaborators
Ceterix Orthopaedics, Inc.
Investigators
Principal Investigator: Peter R Kurzweil, MD Memorial Orthopedic Surgical Group Long Beach
  More Information

Publications:
Responsible Party: Ceterix Orthopaedics, Inc.
ClinicalTrials.gov Identifier: NCT02237001     History of Changes
Other Study ID Numbers: CTX-CP001
Study First Received: September 6, 2014
Last Updated: February 15, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Ceterix Orthopaedics, Inc.:
meniscal
meniscus
repair
knee
arthroscopy knee
horizontal

ClinicalTrials.gov processed this record on May 23, 2017