Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults

Study Overview
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Brief Summary
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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
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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): 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. 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.

Official Title
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Danish Rct on Exercise Versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) - A Randomized Controlled Trial of Meniscal Tear Treatment in Young Adults

Conditions
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Tear of Meniscus of Knee

Intervention / Treatment
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* Procedure: Arthroscopic meniscal repair or resection
* Behavioral: Exercise and education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 to 40 years with knee pain Clinical history and symptoms consistent with meniscal tear and meniscal tear verified on magnetic resonance imaging (MRI) Deemed eligible for meniscal surgery (i.e. repair or resection) by the examining orthopedic surgeon Willing to participate in 12 weeks of supervised exercise twice a week or undergo surgery for the meniscal tear as soon as possible Exclusion Criteria: Previous knee surgery on the affected knee Clinical suspicion (acute locking of knee AND/OR extension deficit) of displaced bucket-handle tear confirmed by MRI Fracture of the affected extremity within the previous 12 months Complete rupture of one or more knee ligaments. Participation in supervised systematic exercise for knee problems within the last 3 months prior to recruitment Other reasons for exclusion (Unable to understand Danish, mentally unable to participate, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthroscopy<br>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). | Procedure: Arthroscopic meniscal repair or resection<br>* Arthroscopic meniscal repair or resection following standard procedures.<br>|
| Active Comparator: Exercise and Education<br>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. | Behavioral: Exercise and education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Knee Injury and Osteoarthritis Outcome Score (KOOS4) | The mean score for the KOOS subscales Pain, Symptoms, Function in sports and recreational activities, and Quality of life. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months. | Primary endpoint: Change from baseline to 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The five KOOS subscales | To allow for clinical in-depth interpretation, the primary outcome will be complemented by subscale scores from each of the five individual KOOS subscales. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months. | Primary endpoint: Change from baseline to 12 months. | 
| Western Ontario Meniscal Evaluation Tool (WOMET) | WOMET is a meniscus specific patient-reported outcome measure that will be used to complement the KOOS score. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. Will also be assessed after 24 months. | Primary endpoint: Change from baseline to 12 months. | 
| Isometric muscle strength | Isometric muscle strength will be assessed using the FysioMeter. Assessed at baseline, 3 and 12 months. | Primary endpoint: Change from baseline to 3 months. | 
| The maximum number of knee-bends in 30s | The maximum number of knee-bends in 30s is one of three measures of functional performance. All visits (baseline, 3, 6 and 12 months) will be included in the analysis. | Primary endpoint: Change from baseline to 12 months. | 
| The one-leg hop for distance | The one-leg hop for distance is one of three measures of functional performance. Assessed only at 12 months. | Primary endpoint: 12 months. | 
| The 6 m timed hop | The 6 m timed hop is one of three measures of functional performance. Assessed only at 12 months. | Primary endpoint: 12 months. | 
| Adverse events | Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. Furthermore, the medical records from the participating hospitals will be checked at the primary endpoint (12 months) for all AEs occurring from inclusion until the 12 months follow-up. AEs will be categorized into index knee or other sites and will be recorded and assessed for severity independent of whether or not there is a causal relationship with study treatments. Assessed at 3, 6 and 12 months. Will also be assessed after 24 months. | Primary endpoint: 12 months. | 
| Structural knee joint changes | Structural knee joint changes from baseline to 24 months will be assessed using the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS). | Baseline to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menisci, Tibial, Knee Injuries, Arthroscopy, Exercise, Young adults, Treatment Outcome, Humans