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Meniscal tear outcome Study (METRO Study): a study protocol for a multicentre prospective cohort study exploring the
Imran Ahmed1, Mike Bowes2, Charles E Hutchinson3
1Warwick Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK imran.ahmed4@nhs.net.
Introduction:
This study is designed to explore the baseline characteristics of patients under 55 years of age with a meniscal tear, and to describe the relationship between the baseline characteristics and patient-reported outcome measures (PROMs) over 12 months. Research has highlighted the need for a trial to investigate the effectiveness of arthroscopic meniscectomy in younger patients. Before this trial, we need to understand the patient population in greater detail.
Methods And Analysis:
This is a multicentre prospective cohort study. Participants aged between 18 and 55 years with an MRI confirmed meniscal tear are eligible for inclusion. Baseline characteristics including age, body mass index, gender, PROMs duration of symptoms and MRI will be collected. The primary outcome measure is the Western Ontario Meniscal Evaluation Tool at 12 months. Secondary outcome measures will include PROMs such as EQ5D, Knee Injury and Osteoarthritis Outcome Score and patient global impression of change score at 3, 6 and 12 months.
Ethics And Dissemination:
The study obtained approval from the National Research Ethics Committee West Midlands-Black Country research ethics committee (19/WM/0079) on 12 April 2019. The study is sponsored by the University of Warwick. The results will be disseminated via peer-reviewed publication.
Trial Registration Number:
UHCW R&D Reference: IA428119. University of Warwick Sponsor ID: SC.08/18-19.
