NCT05534724

A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Ente Ospedaliero Cantonale, Bellinzona · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.

Detailed description

The surgical operation will be carried out according to the standard clinical practice, namely following the modified Lapidus general and specific rules concerning the surgical treatment of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion. Post-operatively, patients who meet the eligibility criteria will be randomized into one of the two groups (partial weight-bearing limited at 15kg vs full weight-bearing) Patient in both groups will be wearing a VACOPASO shoe for 6 weeks. Standard X-ray assessment to determine healing, hardware fixation, fracture alignment, fracture reduction, implants mobilization will be performed at weeks 6, 12, 24. Change in pain severity from the day of surgery to 6, 12 and 24 weeks postoperatively will be measured using the pain Visual Analogue Scale (VAS). Quality of life will be assessed through the American Orthopedic Foot and Ankle Score (AOFAS). Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).

Conditions

• Hallux Valgus
• Orthopedic Disorder

Interventions

Type	Name	Description
OTHER	Partial weight-bearing (10 - 15kg)	Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks
OTHER	Complete weight-bearing	Complete post-operative weight-bearing with a VACOPASO shoe for 6 weeks

Timeline

• Start date: 2023-01-19
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2022-09-09
• Last updated: 2025-08-06

Locations

1 site across 1 country: Switzerland