Prospective Preference Assessment of a Pharmacological Clinical Trial to Alter the Progression of Posttraumatic Osteoarthritis After ACL Reconstruction.

Abstract

Background: Understanding the factors contributing to willingness to participate in randomized clinical trials (RCTs) after anterior cruciate ligament reconstruction (ACLR) is crucial to optimizing recruitment and understanding whether interested participants represent the patient population that may benefit from the studied treatment.

Purpose: To understand patients' willingness to participate in a future RCT of an oral medication to prevent posttraumatic osteoarthritis (PTOA) after ACLR.

Study design: Cross-sectional study; Level of evidence, 3.

Methods: A total of 103 patients aged 18 to 45 years who were either planning to undergo ACLR in the next 4 months or had undergone ACLR within 1 year of the screening date were recruited from 2 institutions. The patients viewed a video explaining the trial and completed a questionnaire that included demographic characteristics, pain intensity, activity level, willingness to participate in the hypothetical trial, and their perceived risk (on a scale of 0%-100%) of developing knee PTOA (next 10 years or lifetime).

Results: Within the cohort, 31% stated they were "definitely willing," 38% were "probably willing," 17% were "unsure," and 14% were "unwilling" to participate in a hypothetical trial. Willingness did not differ by pain or activity level; however, younger patients stated they were less willing to participate. The most common reasons for unwillingness to participate included not wanting to take a medication daily (59%) and concerns about medication risks or side effects (59%). Respondents who indicated a definite willingness to participate in the trial had higher perceptions of their own PTOA risk over the next 10 years than those who indicated they would not participate (70% vs 50%).

Conclusion: In this prospective preference assessment, 69% of survey respondents expressed a willingness to participate in an RCT involving an oral medication to potentially alter the progression of PTOA after ACLR. The results suggest that an RCT in this study should include clear and concise information on the risk of developing PTOA after ACLR and the safety and tolerability of study medications in the recruitment materials.