Effects of crutch-assisted walking on pain, gait, and hip function in early and middle-stage osteonecrosis: a randomized trial.

Background: Early-to middle-stage osteonecrosis of the femoral head (ONFH) is commonly associated with pain, gait impairment, and functional limitation. Although protective weight-bearing is frequently recommended, high-quality evidence supporting standardized crutch use as a non-surgical intervention remains limited. Objective: To evaluate the effects of daily crutch-assisted walking on pain, hip function, gait performance, health-related quality of life, and bone metabolic markers in patients with early-to middle-stage ONFH. Methods: In this single-center randomized controlled trial, 56 patients (96 hips) with ARCO stage I-IIIA ONFH were randomly assigned to a crutch-assisted walking group (3 months of daily use) or a control group without walking aids. Both groups received standardized pharmacological treatment. Outcomes were assessed at baseline, 45 days, and 90 days. The primary outcome was pain intensity measured by the visual analog scale (VAS). Secondary outcomes included the Harris Hip Score (HHS), hip range of motion, spatiotemporal gait parameters, SF-36 scores, and serum biomarkers related to inflammation and bone metabolism. Linear mixed-effects models were applied to account for repeated measurements and bilateral hip clustering. Results: At 90 days, the crutch-assisted walking group showed lower VAS scores compared with controls (adjusted mean difference -3.1, 95% CI -3.8 to -2.5; P < 0.001). Improvements were also observed in HHS, selected gait parameters, and several exploratory serum biomarkers, including osteocalcin, total procollagen type I amino-terminal propeptide, and interleukin-6. No significant between-group difference was observed in NSAID consumption. No serious adverse events were reported. Conclusion: Standardised daily crutch-assisted walking may provide short-term symptomatic and functional benefits in patients with early-to middle-stage ONFH. However, given the modest sample size, relatively short follow-up duration, and exploratory nature of several secondary outcomes, these findings should be interpreted cautiously. Further studies are required to determine whether these short-term improvements translate into long-term structural or clinical benefits. Trial registration: This study was registered at the Chinese Clinical Trial Registry on January 8, 2025, with registration number ChiCTR2500095502. The translational potential of this article: The findings of this randomized controlled trial provide translational evidence supporting standardized crutch-assisted walking as a feasible and low-cost conservative intervention for patients with early-to middle-stage osteonecrosis of the femoral head. By demonstrating improvements in pain, gait performance, and hip function without activity restriction, this study informs everyday clinical decision-making and supports the integration of biomechanical unloading strategies into routine non-surgical management.