RecruitingNot ApplicableNCT05534724

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


Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Enrollment

122 participants

Start Date

Jan 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

OTHERPartial weight-bearing (10 - 15kg)

Immediate post-operative partial weight-bearing (10 - 15kg) with a VACOPASO shoe for 6 weeks

OTHERComplete weight-bearing

Complete post-operative weight-bearing with a VACOPASO shoe for 6 weeks


Locations(1)

EOC

Lugano, Switzerland

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NCT05534724


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