Study of Suture Repair of Torn Meniscus in the Knee

Description

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.

Study Start Date

September 2014

Estimated Completion Date

December 2017

Interventions

  • Device: Suture-based meniscal repair

Specialties

  • Orthopedics: Knee,Surgical Technique
  • Physician Assistant: Orthopedics

MeSH Terms

  • Lacerations
  • Meniscal Tear
  • Rupture

Study ID

Ceterix Orthopaedics, Inc. -- CTX-CP001

Status

Unknown

Trial ID

NCT02237001

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

30

Sponsor

Ceterix Orthopaedics, Inc.

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)

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (10)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Katiri T Wagner 617-667-1298 kwagner@bidmc.harvard.edu
NYU Langone Hospital for Joint Diseases - New York, New York 186.5 miles Ariel Aponte 212-460-0176 ariel.aponte@nyumc.org
George Washington University - Washington, District of Columbia 393.9 miles Stacy TamSiu 202-741-2602 Stam@mfa.gwu.edu
University of Virginia - Charlottesville, Virginia 493.4 miles John W Goetschius MEd 434-924-6184 JG2UU@hscmail.mcc.virginia.edu
The Ohio State University - Columbus, Ohio 644.2 miles Isac Kunnath 614-293-2410 Isac.Kunnath@osumc.edu
OrthoIndy South - Greenwood, Indiana 807.8 miles Vicki R SnodgrassMiller BA 317-884-5230 vsmiller@orthoindy.com
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Jennifer L Krogman 507-538-3562 krogman.jennifer@mayo.edu
Andrews Research and Education Foundation INC - Gulf Breeze, Florida 1,214.4 miles Laura Schubert RN 850-916-8590 laura.schubert@andrewsref.org
CORE Orthopaedic Medical Center - Encinitas, California 2,577.4 miles Farouk Awad 760-943-6710 fawad@coreorthopaedic.com
Memorial Orthopedic Surgical Group Long Beach - Long Beach, California 2,600.0 miles Carlos Edwards 562-424-6666 carlosjedwards@gmail.com

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