NCT02995551.

Study name	Danish RCT on Exercise versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) Official title: Danish Rct on Exercise versus Arthroscopic Meniscal Surgery for Young Adults (DREAM) ‐ A Randomized Controlled Trial of Meniscal Tear Treatment in Young Adults
Methods	Study design: prospective, parallel‐arm, multicentre, randomised controlled trial Setting: Denmark Trial time period: January 2017 to June 2018 Interventions: arthroscopic meniscal surgery versus individualised supervised exercise therapy and education Sample size calculations: 59 participants in each of the intervention groups is needed (assuming a common standard deviation (SD) of 16.5, power = 90%, alpha level = 0.05) to detect a clinically relevant difference of 10 points in the primary outcome (KOOS4) from baseline to 12 months' follow‐up. A total of 140 participants will be recruited to account for loss to follow‐up (19%). Analysis: intention‐to‐treat
Participants	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 orthopaedic surgeon Willing to participate in 12 weeks of supervised exercise twice a week and 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 6 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).
Interventions	Arthroscopic meniscal surgery Arthroscopic meniscal repair or resection will be conducted at the discretion of the operating surgeon at one of the six hospitals. The specific surgical procedure (i.e. repair or resection) cannot be determined before the surgeon has visual confirmation about the exact knee pathology and extent of the meniscal tear at arthroscopy. Exercise therapy and patient education Participants allocated to exercise therapy and participant education will twice weekly participate in a 12‐week individualised, supervised exercise programme (approximately 60 to 90 minutes/session) tailored to 18 to 40 years old participants with meniscal tear
Outcomes	Outcomes will be measured at 3, 6 and 12 months' follow‐up Primary outcome Change in Knee injury and Osteoarthritis Outcome Score (KOOS) scores from baseline to follow‐up. KOOS4 is the mean score for the KOOS subscales pain, symptoms, function in sports and recreational activities (Sport/Rec) and quality of life (QOL) Secondary outcomes: KOOS subscales individual scores Western Ontario Meniscal Evaluation Tool (WOMET) scores Physical performance: Isometric muscle strength using the Fysiometer Maximum knee‐bends in 30 seconds One‐leg hop for distance 6 metre timed hop Adverse events
Starting date	January 2017
Contact information	Principal Investigator: Søren Thorgaard Skou, PT, PhD, Assistant Professor, University of Southern Denmark Tel: +4523708640; Email: stskou@health.sdu.dk
Notes	Clinical trial registration:NCT02995551 Trial status: recruiting participants Expected completion date: December 2020