Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults
Condition: Tear of Meniscus of Knee
Study type: Interventional

Summary: 
      There are two cartilage structures in each knee joint called a meniscus. A torn meniscus can
      be caused by either a smaller or larger trauma or be a degenerative age-related tear.
      Arthroscopic meniscal surgery is the most common orthopedic procedure, but no high-quality
      studies have investigated the efficacy of meniscal surgery for younger patients (i.e. 40
      years or younger) in comparison to non-surgical treatments.

      The purpose of this study is to determine if a strategy of early arthroscopic meniscal
      surgery (repair or resection) is superior to a strategy of initial individualized supervised
      exercise therapy including patient education with the option of later surgery if needed in
      improving pain, function and quality of life in young patients (18-40 years) with meniscal
      tears.

      The hypothesis is that patients treated with early arthroscopic meniscal surgery will improve
      more than patients treated with exercise and education.
    

Detailed description: 
      Arthroscopic meniscal surgery is the most common orthopedic procedure. In Denmark, meniscal
      surgeries have doubled from around 9.000 yearly procedures in 2000 to more than 17.000 in
      2011, with the total number of meniscal surgeries exceeding 150.000 in this period. Similar
      trends have been observed in the US, where more than 700.000 orthopedic procedures are
      carried out annually. Numerous randomized controlled trials (RCT) have investigated the
      efficacy of meniscal surgery compared with placebo surgery, in addition to non-surgical
      treatment and in direct comparison to exercise in middle-aged and older patients.

      However, no RCTs have investigated the efficacy of meniscal surgery for younger patients
      (i.e. 40 years or younger) in comparison to non-surgical treatments. In contrast to
      middle-aged and older adults with degenerative meniscal tears of unknown origin, most tears
      in younger adults (18-40 years) are of traumatic origin (i.e. such as a sports related
      trauma), which highlights the need for a high-quality trial in the younger population.

      The aim of this RCT is to investigate if early arthroscopic meniscal surgery (repair or
      resection) is superior to individualized supervised exercise therapy and education, with the
      option of later surgery if needed, in improving pain, function and quality of life in young
      patients (18-40 years) with meniscal tears. The study hypothesis is that patients randomized
      to surgery will improve significantly more in pain, function and quality of life after 12
      months than those randomized to exercise and education.

      Patients fulfilling eligibility criteria and willing to participate in the study will be
      randomized to one of the two groups after the baseline assessment with follow-up after 3, 6
      and 12 months (Subsequently, a 24-month follow-up has been added):

        1. Arthroscopic meniscal surgery: Arthroscopic meniscal repair or resection will be
           conducted at the discretion of the operating surgeon (this cannot be determined before
           the surgeon has visual confirmation about the exact knee pathology and extend of the
           meniscal tear by scope).

           After surgery, patients will receive the standard rehabilitation in the postoperative
           period depending of type of surgery, since this differs for patients who have had
           resection and repair. A standard folder with exercises will be given to those having a
           partial meniscectomy to ensure a minimum level of rehabilitation after the surgery
           across the hospitals.

        2. Exercise therapy and patient education: Patients allocated to exercise therapy and
           education will participate in a 12-week (2 exercise sessions per week) supervised
           neuromuscular and strengthening exercise program tailored to 18-40 years old patients
           with a meniscal tear. Furthermore, they will participate in a patient education program
           developed through interviews with pilot study participants, from our experiences from
           the Good Life with osteoArthritis in Denmark (GLA:D) program for patients with knee and
           hip pain. Both the exercise and education will take place in a number of private
           physiotherapy clinics associated with the GLA:D program, specifically trained to
           supervise and lead the treatment in this study. A similar exercise program and
           educational program have been shown to be effective in improving pain, function and
           quality of life in patients with other types of knee injuries and knee pain.

      Observational cohort:

      Patients fulfilling all eligibility but unwilling to participate in the randomized study and
      patients 18-40 years of age with a clinical history and symptoms consistent with a meniscal
      tear that does not fulfill the other criteria are asked to participate in an observational
      cohort with the same questionnaires as in the RCT, but following usual clinical practice.
    

Intervention name(s): Arthroscopic meniscal repair or resection; Exercise and education
Intervention type(s): Procedure; Behavioral
Intervention description(s): Arthroscopic meniscal repair or resection following standard procedures.; A 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear combined with patient education teaching the participants about their disease and how to manage it through exercise and in their daily life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Menisci, Tibial; Knee Injuries; Arthroscopy; Exercise; Young adults; Treatment Outcome; Humans