The impact of the COVID-19 pandemic on recruitment in a multi-center clinical trial of rotator cuff tears
Mark A Newman1
, Rashmi Pathak2, Folefac D Atem3, Nitin B Jain2
1Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, United States
2Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, United States
3Department of Biostatistics and Data Science, The University of Texas Health Science Center at Houston, Houston, TX, United States
Keywords: COVID-19, musculoskeletal, physical therapy, randomized clinical trial, rotator cuff tears, surgery.
Abstract
Objectives: This study aims to examine screening and accrual data from a unique multi-center clinical trial for rotator cuff tears before and after the trial was paused due to the novel coronavirus disease 2019 (COVID-19) pandemic.
Patients and methods: Between March 2018 and December 2023, the Operative versus Non-operative Treatment for Atraumatic Rotator Cuff Tears (ARC) trial data were used and screening and enrollment trends were analyzed before and after the trial was paused due to COVID-19. Demographic data, clinical characteristics, Mental Health Inventory (MHI), Shoulder Pain and Disability Index (SPADI), and the American Shoulder and Elbow Surgeons (ASES) questionnaire scores were evaluated for all individuals who were screened and randomized into the study.
Results: Among screened individuals, the proportion identifying as non-Hispanic or non-Latino was higher before the COVID-19-related trial pause (86.68%) than after the pause (75.01%). A lower percentage of individuals with an unknown or not reported ethnicity was observed before the trial was paused (9.56%) than after the trial resumed (21.9%). Notable recruitment findings included a higher proportion of individuals who declined to receive further information about the trial after the COVID-19-related pause (35.08%) than before the pause (6.81%). Additionally, patient-, provider-, and healthcare system-specific barriers to recruitment were identified based on screening and enrollment data.
Conclusion: The 20-month pause in this trial due to the COVID-19 pandemic introduced several patient-, provider-, and healthcare system-specific recruitment barriers that may have prolonged the study timeline.
Citation: Newman MA, Pathak R, Atem FD, Jain NB. The impact of the COVID-19 pandemic on recruitment in a multi-center clinical trial of rotator cuff tears. Arch ISPRM 2026;1(x):i-xii. https://doi.org/10.5606/archisprm.2026.37.