COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284661
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : November 30, 2015
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Fowler Kennedy Sport Medicine Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Meniscal Tear Procedure: FAST FIX Procedure: Meniscal suturing Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Meniscal Repair: A Randomized Prospective Trial of FAST-FIX vs. Meniscal Suturing
Study Start Date : June 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Quality of life at 2 years as measured by The Western Ontario Meniscal Evaluation Tool (WOMET) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Side-to-side difference in knee joint range of motion [ Time Frame: 2 years ]
  2. Other physical symptoms such as joint line pain/tenderness, knee effusion [ Time Frame: 2 years ]
  3. Re-tear rate (as confirmed by MRI or arthroscopy), Functional outcome scores [ Time Frame: 2 years ]
  4. Surgical time [ Time Frame: day 0 ]
  5. Complication rate [ Time Frame: 2 years ]
  6. Differences between groups in post-operative pain [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00284661

Layout table for location information
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.
Layout table for investigator information
Principal Investigator: Kevin Willits, MD University of Western Ontario, Canada
Layout table for additonal information
Responsible Party: Fowler Kennedy Sport Medicine Clinic Identifier: NCT00284661    
Other Study ID Numbers: 11125
R3773A01 ( Other Grant/Funding Number: Smith and Nephew )
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015
Keywords provided by Fowler Kennedy Sport Medicine Clinic:
Meniscal repair
Meniscal suturing
Meniscal tear