The role of orthotic devices in managing hallux rigidus: A systematic review and meta-analysis of clinical and biomechanical outcomes

Abstract

INTRODUCTION: Hallux rigidus, or restricted dorsiflexion of the first metatarsophalangeal joint, is a frequent musculoskeletal disorder disrupting gait biomechanics and general health. This review extends existing literature by providing a focused synthesis of biomechanical and clinical outcomes associated with different orthotic designs in hallux rigidus, highlighting their moderate effectiveness and the substantial heterogeneity in outcome measures and orthotic configurations. METHODS: Scopus, PubMed, and Web of Science were searched for randomized controlled trials that assessed the effects of orthotic devices on clinical and biomechanical outcomes among adults aged 18-65 years with clinically diagnosed Hallux rigidus. The methodological quality was evaluated using the Cochrane Risk of Bias Tool for Randomized Trials. Data were synthesized using both narrative (data summarization and description) and quantitative (using random-effects models meta-analyzed to calculate standardized mean differences (SMDs) with 95 confidence intervals (CIs)) approaches. RESULTS: Eleven RCTs were included. Cut-out insoles reduce transverse plane foot motion and redistribute pressure from the forefoot to the midfoot and heel, while anterior forefoot stabilizer insoles decrease ankle and midfoot stiffness and shift loading posteriorly. Shoe-stiffening insoles reduce ankle and first metatarsophalangeal joint dorsiflexion and increase knee flexion, whereas rocker-sole shoes decrease hip range of motion and alter spatiotemporal gait parameters. A 3 mm support under the first MPJ significantly increased maximum extension of the hallux. Additionally, orthoses led to decreased pain. First metatarsal plantarflexion during gait was significantly improved by cut-out orthoses (SMD: 0.61; 95 CI: (0.31-0.92); p < 0.05). However, foot function index scores showed no change (SMD: -4.27; 95 CI: (-8.55-0.01); p > 0.05) with high heterogeneity (I(2) = 97). CONCLUSION: Orthotic appliances are of moderate effectiveness in remedying biomechanical function in Hallux rigidus. Clinical results differ significantly because of the diversity in orthosis design, the various measures used for outcomes, and the duration of follow-up.