Status:
COMPLETED
Study of Suture Repair of Torn Meniscus in the Knee
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Meniscal Tear
Meniscus Tear
Eligibility:
All Genders
18-60 years
Phase:
NA
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 asses...
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...
Eligibility Criteria
Inclusion
- Screening
- 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
- 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
- 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
Key Trial Info
Start Date :
November 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02237001
Start Date
November 19 2014
End Date
November 18 2019
Last Update
December 4 2020
Active Locations (8)
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1
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
2
Memorial Orthopedic Surgical Group Long Beach
Long Beach, California, United States, 90806
3
Andrews Research and Education Foundation, INC
Gulf Breeze, Florida, United States, 32561
4
OrthoIndy South
Greenwood, Indiana, United States, 46143