Meniscal Repair: A Randomized Prospective Trial of FAST-FIX vs. Meniscal Suturing
Condition: Meniscal Tear
Study type: Interventional

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
    

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 between groups in the disease specific quality of life assessment - The
      Western Ontario Meniscal Evaluation Tool. Secondary outcome measures include range of motion,
      functional outcome scores, surgical time, complication rate, meniscal retear and differences
      between groups in post-operative pain. The data collector will be blinded to patients'
      intervention group. Secondary outcome measures include range of motion, functional outcome
      scores, disease-specific quality of life outcome scores and the standard knee clinical
      examination.

      Study Population: The investigators will assess all patients presenting with suspected
      meniscal tears. Those meeting the inclusion/exclusion criteria will be asked to sign an
      informed consent. Subjects who have successfully been screened and are slated to be
      randomized into the study must have a pre-operative visit within 12 months of their scheduled
      surgery.

      Routine knee x-rays will be performed on all patients to rule out extensive degenerative
      changes, loose bodies, fractures, osteochondritis dissecans and other lesions.

      Treatment Protocols: Intervention group assignment will take place at the time of surgery,
      once the patient has undergone the initial arthroscopy and a diagnosis of a repairable
      meniscal tear has been confirmed. Patients will be stratified for surgeon and for concurrent
      ACL reconstruction. They will then be randomized to one of the two treatment groups.

      Meniscal repair is a day surgery procedure performed under general anaesthesia and tourniquet
      control as required. Prior to the repair, synovial abrasion and debridement of scar tissue
      will be carried out to promote vascular ingrowth.

      FasT-Fix Technique A suture that is pre-attached to a T-bar is placed across the meniscal
      tear via a sheathed needle. A small obturator pushes the "T" out of the needle engaging the
      outer rim of the meniscus in the synovial recess. The suture tails are tied arthroscopically,
      stabilizing the tear.

      Inside-Out Suturing Technique Repairs of the medial meniscus will be carried out with the
      knee in 10-30° flexion. This allows both preservation of the posterior capsular recess and
      full knee extension once the repair is complete. A vertical incision is made posterior to the
      medial collateral ligament. The deep fascia is incised and the posteromedial capsule
      visualized. The lateral meniscus is repaired through a vertical incision posterior to the
      lateral collateral ligament made with the knee flexed 90°. The iliotibial band is split in
      line with its fibers at the level of the joint line. The biceps femoris and lateral
      gastrocnemius tendon are retracted posteriorly, protecting the common peroneal nerve and
      exposing the capsule and popliteus tendon. Vertical sutures will be placed in at 5mm
      intervals along the tear. Sutures are tied over the capsule once ligamentous reconstruction,
      if necessary, is completed. This is done with the knee in full extension.

      Assessments: Patients will be assessed pre-operatively and by a blinded research assistant at
      3, 6, 12, and 24 months. A tubi-grip will cover the operative knee in order that the data
      collector may be blinded to treatment group. Effusion and joint-line tenderness will be
      assessed by the physician prior to the data collector's appraisal. The viability of the
      meniscal repair will be based on the clinical examination. The absence of effusion,
      joint-line tenderness and locking all correlate well with a healed meniscus. The
      International Knee Documentation Form, the Western Ontario Meniscal Evaluation Tool and the
      Lysholm score, validated measures for knee problems will be utilized. Patients will be asked
      to complete a pain journal for a period of 2 weeks following their surgery.
    

Intervention name(s): FAST FIX; Meniscal suturing
Intervention type(s): Procedure; Procedure
Intervention description(s): Fast fix repair of a meniscal tear; standard suturing of meniscal tear
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniscal repair; Meniscal suturing; Meniscal tear