Study of Suture Repair of Torn Meniscus in the Knee

Status:Active, not recruiting
Age Range:18 - 60
Start Date:September 2014
End Date:February 2020

Use our guide to learn which trials are right for you!

A Prospective, Non-randomized, Multi-Center Investigation of All-suture-based Repair of Horizontal Meniscal Tears (STITCH Study)

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.

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.

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)
We found this trial at
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: F. W Gwathmey, M.D.
Phone: 434-924-6184
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
Charlottesville, VA
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: David Flanigan, M.D.
Phone: 614-293-2410
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Columbus, OH
Click here to add this to my saved trials
Encinitas, California 92024
Principal Investigator: Greg J Loren, M.D.
Phone: 760-943-6710
Encinitas, CA
Click here to add this to my saved trials
Greenwood, Indiana 46143
Principal Investigator: Jack Farr, M.D.
Phone: 317-884-5230
Greenwood, IN
Click here to add this to my saved trials
Gulf Breeze, Florida 32561
Principal Investigator: Adam Anz, M.D.
Phone: 850-916-8590
Gulf Breeze, FL
Click here to add this to my saved trials
Long Beach, California 90806
Principal Investigator: Peter R Kurzweil, MD
Phone: 562-424-6666
Long Beach, CA
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: Aaron Krych, M.D.
Phone: 507-538-3562
Rochester, MN
Click here to add this to my saved trials
1850 M Street Northwest
Washington, District of Columbia 20038
Click here to add this to my saved trials
Winchester, Virginia 22604
Winchester, VA
Click here to add this to my saved trials