5E management protocol for enhanced recovery after total knee arthroplasty: stratified RCT
摘要
Total knee arthroplasty (TKA) is an effective treatment for end-stage knee osteoarthritis; however, postoperative recovery is frequently hindered by inadequate pain control and delayed functional rehabilitation. Conventional perioperative management often focuses primarily on surgical technique and pharmacologic analgesia, while underemphasizing other modifiable factors such as patient education, nutritional status, and psychological well-being. To address these gaps, we developed a structured multimodal perioperative strategy—the 5E management protocol—integrating Education, Exercise, Eat (nutritional optimization), Emotion (psychological support), and Ease (multimodal pain control). The purpose of this randomized controlled trial was to determine whether the 5E protocol improves early postoperative pain control and functional recovery after TKA, and whether its effects are consistent across clinically relevant patient subgroups.
MethodsIn this single-center randomized controlled trial, 120 patients undergoing primary TKA for osteoarthritis were randomly assigned to either the 5E management protocol (n = 60) or conventional perioperative care (n = 60). Patients in the 5E group received standardized preoperative education, optimized multimodal analgesia, early mobilization, individualized nutritional support, and structured psychological counseling, whereas the control group received routine care. Postoperative pain was assessed using the Visual Analog Scale (VAS) and Numerical Rating Scale (NRS) during postoperative days 1–5. Functional outcomes were evaluated using the Knee Society Score (KSS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) index at 30 days and 180–360 days postoperatively. Stratified subgroup analyses were performed based on body mass index (BMI), diabetic status, and Kellgren–Lawrence (K-L) grade.
ResultsPatients managed with the 5E protocol demonstrated significantly better pain control during the early postoperative period compared with those receiving conventional care (VAS day 1: 1.95 vs. 3.08; P < 0.001), with similar trends observed across postoperative days 1–5. At 30 days, the 5E group achieved superior functional outcomes, including higher KSS Pain and Function Scores and lower WOMAC scores (KSS Pain: 67.48 vs. 64.23; P < 0.001). Stratified analyses showed consistent benefits of the 5E protocol across BMI categories, diabetic and non-diabetic patients, and K&L grades 3–4. No significant differences were observed between groups at long-term follow-up (180–360 days). Thrombotic complications (Intramuscular venous thrombosis) occurred in 10 of 60 patients (16.7%) in the 5E group and 8 of 60 patients (13.3%) in the control group, with no significant difference between groups (P = 0.798).
ConclusionThe 5E management protocol significantly improves early postoperative pain control and short-term functional recovery after TKA, with consistent benefits across diverse patient subgroups. Although long-term outcomes were comparable between groups, the acceleration of early recovery highlights the clinical value of a structured, patient-centered, multimodal perioperative strategy. Importantly, the implementation of the 5E protocol did not increase thrombotic complications, indicating a comparable safety profile to conventional care.
Level of evidence ITherapeutic Study.