To Walk or Not? A Prospective, Randomised Controlled Trial to Evaluate the Effect of Weightbearing on Patient Outcomes Following First Metatarsophalangeal Joint Fusion

Abstract

Background: First metatarsophalangeal (MTP) joint arthrodesis is the gold standard surgical treatment of hallux rigidus and severe hallux valgus with osteoarthritis after failed nonoperative management. Despite its common use, postoperative weightbearing protocols vary considerably. To date, no prospective randomised controlled trials have directly compared outcomes between immediate weightbearing as tolerated (WBAT) and non-weightbearing (NWB) using modern fixation techniques. This study aimed to evaluate whether immediate WBAT following first metatarsophalangeal joint arthrodesis leads to differences in patient outcomes compared with traditional non-weightbearing protocols. Methods: A prospective randomised controlled trial was conducted including 68 patients undergoing isolated first-MTP fusion. Patients were randomly allocated either WBAT or NWB protocols. Standardised surgical technique and fixation (crossed screws or plate) were performed by 2 fellowship-trained foot and ankle surgeons. Primary outcomes were the visual analogue scale (VAS) pain scores and the Foot and Ankle Ability Measure (FAAM–activities of daily living [ADL] subscale) functional scores, at 12 months. Secondary outcomes included non-union, complications including infection, wound issues, and patient satisfaction. Statistical analysis used t tests and χ 2 or Fisher exact tests, with significance at P < .05. Results: Sixty-eight patients (33 WBAT, 35 NWB) completed follow-up. Both groups demonstrated significant improvements in pain and function at 12 months ( P < .001 for both). No statistically significant differences were found between WBAT and NWB groups in VAS pain scores (2.97 ± 2.215 vs 2.54 ± 2.147; P = .423), FAAM scores (81.31 ± 16.028 vs 85.02 ± 18.863; P = .387), or patient satisfaction (8.00 ± 2.76 vs 8.34 ± 2.52; P = .594). Complication rates were comparable, with 1 case of hardware irritation in each group ( P = .739). Conclusion: Following first-MTP joint fusion, immediate weightbearing is safe and results in similar pain relief, patient satisfaction, and complication rates compared with traditional NWB protocols, although a clinically meaningful functional advantage for NWB could not be excluded. These findings support more permissive postoperative strategies, which may offer benefits for patient mobility, independence, recovery time, and health care resource use that were not directly measured in this trial. Level of Evidence: Level I, randomised controlled trial. ClinicalTrials.gov ID: NCT04473196