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

This study has been completed.
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Fowler Kennedy Sport Medicine Clinic Identifier:
First received: January 31, 2006
Last updated: November 26, 2015
Last verified: November 2015

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
Meniscal Tear
Procedure: FAST FIX
Procedure: Meniscal suturing

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

Resource links provided by NLM:

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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side-to-side difference in knee joint range of motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Other physical symptoms such as joint line pain/tenderness, knee effusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Re-tear rate (as confirmed by MRI or arthroscopy), Functional outcome scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Surgical time [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • Complication rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Differences between groups in post-operative pain [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

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)
Arms Assigned Interventions
Experimental: FAST FIX
Inetrvention is Fast Fix repair of meniscal tear
Procedure: FAST FIX
Fast fix repair of a meniscal tear
Experimental: Meniscal suturing
Intervention is Standard suturing of meniscal tear
Procedure: Meniscal suturing
standard suturing of meniscal tear

  Show Detailed Description


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00284661

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.
Principal Investigator: Kevin Willits, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Fowler Kennedy Sport Medicine Clinic Identifier: NCT00284661     History of Changes
Other Study ID Numbers: 11125, R3773A01
Study First Received: January 31, 2006
Last Updated: November 26, 2015
Health Authority: Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:
Meniscal repair
Meniscal suturing
Meniscal tear processed this record on November 30, 2015