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

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ClinicalTrials.gov Identifier: NCT02237001
Recruitment Status : Active, not recruiting
First Posted : September 11, 2014
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ceterix Orthopaedics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Meniscal Tear Meniscus Tear Device: Suture-based meniscal repair Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)
Actual Study Start Date : September 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Treatment
Suture-based meniscal repair
Device: Suture-based meniscal repair
Suture-based meniscal repair




Primary Outcome Measures :
  1. 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 :
  1. 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.



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237001


Locations
United States, California
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
Memorial Orthopedic Surgical Group Long Beach
Long Beach, California, United States, 90806
United States, District of Columbia
The Orthopaedic Center, PA
Washington, District of Columbia, United States, 20038
United States, Florida
Andrews Research and Education Foundation, INC
Gulf Breeze, Florida, United States, 32561
United States, Indiana
OrthoIndy South
Greenwood, Indiana, United States, 46143
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43221
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Winchester Medical Center
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
Ceterix Orthopaedics, Inc.
Investigators
Principal Investigator: Peter R Kurzweil, MD Memorial Orthopedic Surgical Group Long Beach

Publications:
Responsible Party: Ceterix Orthopaedics, Inc.
ClinicalTrials.gov Identifier: NCT02237001     History of Changes
Other Study ID Numbers: CTX-CP001
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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