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

Ente Ospedaliero Cantonale, Bellinzona

Status: Enrolling

Conditions: Orthopedic Disorder; Hallux Valgus

Treatments: Other: Partial weight-bearing (10 - 15kg); Other: Complete weight-bearing

Study type: Interventional

Funder types: Other

Identifiers

NCT05534724

ORL-ORT-033

Details and patient eligibility

About

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.

Full 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).

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Partial weight-bearing (10 - 15kg)

Other group

Description:

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

Treatment:

Other: Partial weight-bearing (10 - 15kg)

Complete weight-bearing

Experimental group

Description:

Immediate post-operative complete weight-bearing with a VACOPASO shoe for 6 weeks and antithrombotic prophylaxis

Treatment:

Other: Complete weight-bearing