Meniscal Repair: A Randomized Prospective Trial of FAST-FIX vs. Meniscal Suturing

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by:
Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:
NCT00284661
First received: January 31, 2006
Last updated: April 7, 2014
Last verified: September 2006
  Purpose

Meniscal repair resulting in meniscal preservation is the most desirable treatment of a torn meniscus and is one of the most commonly performed arthroscopic procedures. The inside-out meniscal suturing technique allows precise placement of sutures under direct visualization and studies have reported excellent healing rates and low re-tear rates. However, complications associated with the use of the inside-out technique (injury to the knee's neurovascular structures and infection) and the fact that it is a time consuming procedure have generated the development of alternative methods and devices. The FasT-Fix is reported to be quicker and safer. It is applicable to tears in most locations and requires no additional incisions or portals. Even though this and many similar devices are widely used with reported clinical healing rates of 75 -92% and relatively minor complications, few prospective, randomized clinical trials evaluating and comparing different techniques have been carried out. Patient outcome studies are necessary to evaluate which technique ultimately results in the most effective repair and the least patient disability following surgery.

We hypothesize that an inside-out suturing technique will have a higher complication rate but a significantly lower failure rate than the FasT-Fix Menisical Repair System


Condition Intervention
Torn Reparable Meniscus
Procedure: Meniscal repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Meniscal Repair: A Randomized Prospective Trial of FAST-FIX vs. Meniscal Suturing

Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:
  • Quality of life at 2 years as measured by The Western Ontario Meniscal Evaluation Tool (WOMET)

Secondary Outcome Measures:
  • Side-to-side difference in knee joint range of motion
  • Other physical symptoms such as joint line pain/tenderness, knee effusion
  • Re-tear rate (as confirmed by MRI or arthroscopy), Functional outcome scores
  • Surgical time
  • Complication rate
  • Differences between groups in post-operative pain

Estimated Enrollment: 132
Study Start Date: June 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-** Canadians Only can be recruited for this trial

  • History indicative of meniscal pathology (i.e. pain, locking, clicking or giving way of the knee) +/- ACL insufficiency
  • On physical exam, evidence of a meniscal tear (i.e. a locked joint, joint line tenderness and pain on meniscal compression +/- evidence of an ACL tear
  • Vertical tears in the peripheral 0-5mm of the meniscus that are reducible

Exclusion Criteria:

  • Intraarticular/Extraarticular knee infection
  • Metabolic bone, collagen, crystalline joint or neoplastic disease
  • Previous meniscal repair
  • Meniscal tears that are in the avascular zone
  • Stable meniscal tears, i.e. tears <10mm and displaced < 3mm, partial tears
  • Radial, horizontal or flap tears
  • Unwillingness to comply with the rehabilitation protocol or to be followed for 2 years
  • Inability or unwillingness of subject /legal guardian to give written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284661

Locations
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic, University of Western Ontario
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Fowler Kennedy Sport Medicine Clinic
Smith & Nephew, Inc.
Investigators
Principal Investigator: Kevin Willits, MD University of Western Ontario, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00284661     History of Changes
Other Study ID Numbers: 11125, R3773A01
Study First Received: January 31, 2006
Last Updated: April 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:
Meniscal repair
Meniscal suturing
Meniscal tear

ClinicalTrials.gov processed this record on April 17, 2014