Feasibility objectives | Feasibility outcomes | Evaluation metrics | Analysis |
Intervention adherence | Percentage of patients receiving at least 3 of the 4 trial intervention components |  > 90% feasible; 80–90% to consider design modifications; < 80% not feasible | Descriptive |
Patient recruitment | Time to recruit target sample size | We aim to recruit 100 patients in 4Â months | |
Patient retention | Percentage of follow up at 12 months |  > 90% feasible; 80–90%-consider design modifications;  < 80%-not feasible | |
Clinical Objectives | Clinical outcomes | Analysis | |
Opioid-free pain control | Time to three or more consecutive days of < 4/10 pain score on a 0–10 NRS with no opioid use for the operated knee | hazard ratios, 95% CI; Kaplan–Meier survival curve | |
Presence of chronic postsurgical pain (CPSP) at 3, 6, 9 and 12Â months | Presence of CPSP as adopted in the International Classification of Diseases (ICD)-11 version by World Health Organization | descriptively as point estimates and 95% CI by group, with minimally important differences presented for context | |
CPSP pain intensity at rest and movement | Average pain score over the previous week in 0–10 NRS | ||
Presence of persistent opioid use (POU) | Presence of daily opioid use, started after surgery or increased after surgery (binary) | ||
Satisfaction with pain control at 3, 6, 9 and 12 months | Using a 0 to 100 scale (0 = extremely dissatisfied, 100 = extremely satisfied) | ||
Return to function at 3, 6, 9, and 12Â months | Using the Return to Function questionnaire | ||
Knee function at 3, 6, 9 and 12Â months | Using Oxford Knee Scale (OKS) | ||
Quality of Life | Using Euro-Qol 5 Dimensions (EQ-5D) instrument | ||
Economic analysis | Intervention costs and healthcare resource utilization information as well as information on productivity (e.g. time missed from work) will be collected using a self-administered questionnaire, developed for the purpose of this study | QALYs associated with each study arm will be reported as point estimates along with confidence intervals but not compared in a formal economic evaluation | |
Complications | Surgery-related and knee-related adverse events, pain medication related adverse events, readmissions, and serious adverse events (SAEs) | descriptively by group |