Early Surgery Versus Conservative Therapy for Meniscal Injuries in Older Patients
Condition: Meniscal Tear
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of both arthroscopic knee surgery
      and physical therapy in the treatment of non-obstructive meniscal injuries in older patients.

      The investigators assume equal improvement of physical function in both groups and reduced
      costs with conservative treatment.
    

Detailed description: 
      Rationale: Arthroscopic Partial Meniscectomy (APM) is the most performed orthopaedic
      procedure and is current standard treatment for patients with meniscal tears. Since
      superiority of APM over conservative treatment has not well been described and studies with
      direct comparison between APM and conservative treatment are sparse, therefore there is risk
      of large healthcare inefficiency.

      Study design: Non-inferiority multicenter randomized controlled trial with an economic
      evaluation alongside. The study will be conducted by the Orthopaedic Research Consortium
      Mid-West Netherlands and performed in 6 clinics, including 2 academic medical centers.

      402 patients between 45 and 70 years with Magnetic Resonance Imaging (MRI)-confirmed
      symptomatic, non-obstructive meniscal tears will be included. Patients will be assigned to
      either APM (n=201) or Physical Therapy (PT; n=201), with optional delayed APM (cross-over)
      when conservative treatment has failed. Block randomization will be done stratified for age
      and site. Data will be analysed on both intention to treat and per protocol basis.

      Measurement points:

        -  Patients will be asked to complete questionnaires at baseline and 3, 6, 9, 12, 18, 24
           and 60 months.

        -  At both 3 and 24 months they will visit the outpatient department for physical
           examination.

        -  At 24 and 60 months an X-ray will be obtained.

      Sample size calculation: 402 patients, based on a power of 90%, an alpha of 0.05, a standard
      deviation of 20 points and a non-inferiority threshold of 8 points on the IKDC 'Subjective
      Knee Form'. Loss to follow up and cross-over have been taken into account in this
      calculation.
    

Intervention name(s): Arthroscopic Partial Meniscectomy; Physical Therapy
Intervention type(s): Procedure; Other
Intervention description(s): Arthroscopic partial APM is performed within 4 weeks in day-care. No standard physical therapy is prescribed after surgery, as advised by the Dutch Orthopaedic Association Guidelines.; Conservative treatment consist of 16 sessions PT and a home exercise program. These programs are developed for our population, 45-70 years, with a focus on closed-chain strength exercises and cardiovascular exercises.
In case conservative treatment has failed, patients can cross-over and delayed APM is then performed. This can be done, from completion of the PT program, during the entire study.
Other intervention name(s): APM
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tibial meniscus; Arthroscopy; Meniscectomy; Conservative treatment; Physical therapy; Osteoarthritis knee joint