Status:
COMPLETED
Meniscal Repair: A Randomized Prospective Trial of FAST-FIX vs. Meniscal Suturing
Lead Sponsor:
Fowler Kennedy Sport Medicine Clinic
Collaborating Sponsors:
Smith & Nephew, Inc.
Conditions:
Meniscal Tear
Eligibility:
All Genders
16-50 years
Phase:
NA
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 suturin...
Detailed Description
In this prospective, randomized, trial subjects will be randomly assigned to the inside-out group or the FasT-Fix group and will be followed for at least 24 months. Primary outcome is the difference b...
Eligibility Criteria
Inclusion
- \*\* 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00284661
Start Date
June 1 2005
End Date
June 1 2009
Last Update
November 30 2015
Active Locations (1)
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1
Fowler Kennedy Sport Medicine Clinic, University of Western Ontario
London, Ontario, Canada, N6A 3K7