The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial

Abstract

Background Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. MethodsWe did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0-10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361.

Cost‐Effectiveness of Group‐Based Outpatient Physical Therapy After Total Knee Replacement: Results From the Economic Evaluation Alongside the ARENA Multicenter Randomized Controlled Trial

“…Although this may have happened, it was surpassed by the additional therapy sought by patients in the intervention group. The improvement of mean ± SD 0.051 ± 0.21 QALY gains observed at 1 year is higher than QALY gains observed in some other trials in TKR (30–32), but evidence is lacking on what constitutes a meaningful difference for QALY gains measured by the EQ‐5D‐5L instrument and valued using a crosswalk from the 3‐level values. The ARENA intervention is therefore cost‐effective in relation to this observed QALY gain and for a society WTP threshold of £20,000 per QALY gained.…”

High pain reported at 3 months post‐total knee arthroplasty often persists for the next 3 years and is associated with reduced function and quality of life

“…To our knowledge, only one evidence-based programme for persistent pain post-knee arthroplasty has been evaluated with a randomised trial-the STAR programme in the UK (Wylde et al, 2022). This programme provides evidence that early screening for chronic pain at 3-months post-knee arthroplasty (using the same method for identifying high pain used in our cohort) and then a referral reduces mean group pain severity and pain interference at F I G U R E 2 Mean function based on pain status (High/Low) at each time point.…”

Patient-Relevant Outcomes Following First Revision Total Knee Arthroplasty, by Diagnosis

“…Recent evidence suggests that more attention may need to be given to nonoperative treatment. The Support and Treatment After Replacement (STAR) care pathway was found to be more clinically effective and cost-effective than usual care for patients with persistent pain at 3 months following pTKA 40 . The natural history of pain following pTKA also appears to be one of improvement over time, with 1 study demonstrating that two-thirds of patients recovered during the first 4 years postoperatively 41 .…”