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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hallux Valgus, Orthopedic Disorder

Intervention / Treatment
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* Other: Partial weight-bearing (10 - 15kg)
* Other: Complete weight-bearing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Partial weight-bearing (10 - 15kg)<br>Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks, crutches and antithrombotic prophylaxis | Other: Partial weight-bearing (10 - 15kg)<br>* Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks<br>|
| Experimental: Complete weight-bearing<br>Immediate post-operative complete weight-bearing with a VACOPASO shoe for 6 weeks and antithrombotic prophylaxis | Other: Complete weight-bearing<br>* Complete post-operative weight-bearing with a VACOPASO shoe for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS) | 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. | at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on a Visual Analogue Scale | 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). | At the day of surgery, at 6, 12 and 24 weeks postoperatively. | 
| Bone consolidation through anteroposterior and lateral foot x-rays | Incidence of bone consolidation (bone callus formation) assessed in an objective measure by the radiologist | 6 weeks and 12 weeks. At 24 weeks in case of fracture non-union reported at the 12th week postoperatively | 
| American Orthopedic Foot and Ankle Score questionnaire | 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. | at 6, 12 and 24 weeks | 
| Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS) | 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. | at 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Bone consolidation, Foot surgery, Lapidus surgery, Weil surgery, Hohmann surgery, Akin surgery