Clinical trial NCT05534724: A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery
Official title: Is Full Weight Bearing After the Modified Lapidus Operation Possible? A Randomized Controlled Trial to Compare Early and Partial Weight-bearing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallux Valgus
Orthopedic Disorder
Keywords: Quality of life
Bone consolidation
Foot surgery
Lapidus surgery
Weil surgery
Hohmann surgery
Akin surgery
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The surgical operation will be the modified Lapidus arthrodesis of hallux valgus with/without an Akin or a Weil/Hohmann surgery fusion.

Post-operatively, patients will be randomized into one of the two groups:

* Group A (control intervention): immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO for 6 weeks, crutches and antithrombotic prophylaxis.
* Group B (experimental intervention): immediate post-operative complete weight-bearing with a VACOPASO for 6 weeks and antithrombotic prophylaxis.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
timeFrame: at 6 weeks
Secondary outcomes:
measure: Pain on a Visual Analogue Scale
timeFrame: At the day of surgery, at 6, 12 and 24 weeks postoperatively.
measure: Bone consolidation through anteroposterior and lateral foot x-rays
timeFrame: 6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively
measure: American Orthopedic Foot and Ankle Score questionnaire
timeFrame: at 6, 12 and 24 weeks
measure: Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)
timeFrame: at 12 and 24 weeks
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: EOC
Study officials:
affiliation: EOC
name: Martin Riegger, MD
role: PRINCIPAL_INVESTIGATOR
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