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

Not Applicable

Recruiting

• Conditions: Orthopedic Disorder; Hallux Valgus
• Interventions: Other: Complete weight-bearing; Other: Partial weight-bearing (10 - 15kg)

• Registration Number: NCT05534724
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Brief 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).

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-09
• Study Start: 2023-01-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Patient who undergo modified Lapidus arthrodesis operation and associated with:
• Additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (Akin) or interventions on the 2nd and / or 3rd ray (Weil / Hohmann) [23,24].
• Willingness and ability to participate in the trial
• Signed Informed Consent

Exclusion Criteria

• Diabetes mellitus
• Rheumatoid arthritis
• Previous foot surgery
• Classic Lapidus surgery
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
• Inability or contraindications to undergo the investigated intervention
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete weight-bearing	Complete weight-bearing	Immediate post-operative complete weight-bearing with a VACOPASO shoe for 6 weeks and antithrombotic prophylaxis
Partial weight-bearing (10 - 15kg)	Partial weight-bearing (10 - 15kg)	Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks, crutches and antithrombotic prophylaxis

Primary Outcome Measures

Name	Time	Method
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)	at 6 weeks	The Olerud and Molander Ankle Score (OMAS) is a functional rating scale from 0 to 100 and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and activities of daily living. Higher scores mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
Pain on a Visual Analogue Scale	At the day of surgery, at 6, 12 and 24 weeks postoperatively.	Change in pain severity postoperatively measured using the pain Visual Analogue Scale (VAS).; The pain VAS scale is a validated, self-assessment scale in which patients rate their pain by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (0) and "worst pain" (10).
Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)	at 12 and 24 weeks	Subjective functional recovery through the Olerud and Molander Ankle Score (OMAS).; The Olerud and Molander Ankle Score (OMAS) \[7\] is a functional rating scale from 0 to 100 and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and activities of daily living. Higher scores mean a better outcome.
Bone consolidation through anteroposterior and lateral foot x-rays	6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively	Incidence of bone consolidation (bone callus formation) assessed in an objective measure by the radiologist
American Orthopedic Foot and Ankle Score questionnaire	at 6, 12 and 24 weeks	The American Orthopedic Foot and Ankle Score (AOFAS) is used find the quality of life index for foot-and-ankle pathologies. It is made of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. Higher scores mean a better outcome.

Trial Locations

Locations (1)

EOC; 🇨🇭 Lugano, Switzerland