Meniscal Repair: A Randomized Prospective Trial of FAST-FIX vs. Meniscal Suturing
Recruitment status was Recruiting
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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 |
- Quality of life at 2 years as measured by The Western Ontario Meniscal Evaluation Tool (WOMET)
- 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 |
| Estimated Study Completion Date: | June 2009 |
Show Detailed Description
Eligibility| 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| Contact: Anna Hales, RN | ahales@uwo.ca | |
| Contact: Elizabeth Wambolt, BSc, CCRP | ewambolt@uwo.ca |
| Canada, Ontario | |
| Fowler Kennedy Sport Medicine Clinic, University of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 3K7 | |
| Contact: Anna Hales, RN ahales@uwo.ca | |
| Principal Investigator: Kevin Willits, MD | |
| 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: | February 22, 2007 |
| 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 May 19, 2013