NCT00284661

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

4 years

First QC Date

January 31, 2006

Last Update Submit

November 26, 2015

Conditions

Meniscal Tear

Keywords

Meniscal repairMeniscal suturingMeniscal tear

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (6)

  • Side-to-side difference in knee joint range of motion

    2 years

  • Other physical symptoms such as joint line pain/tenderness, knee effusion

    2 years

  • Re-tear rate (as confirmed by MRI or arthroscopy), Functional outcome scores

    2 years

  • Surgical time

    day 0

  • Complication rate

    2 years

  • +1 more secondary outcomes

Study Arms (2)

FAST FIX

EXPERIMENTAL

Inetrvention is Fast Fix repair of meniscal tear

Procedure: FAST FIX

Meniscal suturing

EXPERIMENTAL

Intervention is Standard suturing of meniscal tear

Procedure: Meniscal suturing

Interventions

FAST FIXPROCEDURE

Fast fix repair of a meniscal tear

FAST FIX
Meniscal suturingPROCEDURE

standard suturing of meniscal tear

Meniscal suturing

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \*\* 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fowler Kennedy Sport Medicine Clinic, University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

Study Officials

  • Kevin Willits, MD

    The University of Western Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

June 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

CA(1)