Study of Suture Repair of Torn Meniscus in the Knee

NCT02237001 | Completed Results

• 1 other identifier: CTX-CP001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

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.

Conditions

Meniscal Tear; Meniscus Tear

Keywords

meniscal; meniscus; repair; knee; arthroscopy knee; horizontal

Outcome Measures

Primary Outcomes (1)

• Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation)

  Occurrence of any re-operation of study knee to treat previously repaired meniscal tear during the 2 years following the study procedure.

  6 months, 1 year, and 2 years

Secondary Outcomes (8)

• Change in Knee Pain and Function by Completion of International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Knee Evaluation) at 3 Months, 6 Months, 1 Year, and 2 Years

  Baseline, 3 months, 6 months, 1 year, and 2 years

• Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Pain Score at 3 Months, 6 Months, 1 Year, and 2 Years

  Baseline, 3 months, 6 months, 1 year, 2 years

• Change in Daily Living (ADL) Score at 3 Months, 6 Months, 1 Year, and 2 Years

  Baseline, 3 months, 6 months, 1 year, 2 years

• Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Sport and Recreation Function (Sport) Score at 3 Months, 6 Months, 1 Year, and 2 Years

  Baseline, 3 months, 6 months, 1 year, 2 years

• Change in Knee Pain and Function by the Knee Injury and Osteoarthritis Outcome Score (KOOS): Symptom Score at 3 Months, 6 Months, 1 Year, and 2 Years

  Baseline, 3 months, 6 months, 1 year, 2 years

Study Arms (1)

Treatment

EXPERIMENTAL

Suture-based meniscal repair

Device: Suture-based meniscal repair

Interventions

Suture-based meniscal repair DEVICE

Suture-based meniscal repair

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board
• 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
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

CORE Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

Memorial Orthopedic Surgical Group Long Beach

Long Beach, California, 90806, United States

Location

Andrews Research and Education Foundation, INC

Gulf Breeze, Florida, 32561, United States

Location

OrthoIndy South

Greenwood, Indiana, 46143, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Related Publications (1)

• Kurzweil PR, Lynch NM, Coleman S, Kearney B. Repair of horizontal meniscus tears: a systematic review. Arthroscopy. 2014 Nov;30(11):1513-9. doi: 10.1016/j.arthro.2014.05.038. Epub 2014 Aug 6.

  PMID: 25108905 BACKGROUND

Limitations and Caveats

No limitations reported.

Results Point of Contact

• Title: Kirsten Wall
• Organization: Smith+Nephew, Inc.

Kirsten.wall@smith-nephew.com

720-338-9460

Study Officials

• Peter R Kurzweil, MD

  Memorial Orthopedic Surgical Group Long Beach

  PRINCIPAL INVESTIGATOR

• Darvin Griffin

  Smith & Nephew, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2014
• First Posted: September 11, 2014
• Study Start: November 19, 2014
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: December 4, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)