Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05534724

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases Orthopedic Disorder

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partial weight-bearing (10 - 15kg)

Other

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

Complete weight-bearing

Other

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

Primary outcomes

  1. Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)

    Time frame: 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 outcomes

  1. Pain on a Visual Analogue Scale

    Time frame: 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).

  2. Bone consolidation through anteroposterior and lateral foot x-rays

    Time frame: 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

  3. American Orthopedic Foot and Ankle Score questionnaire

    Time frame: 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.

  4. Subjective functional recovery measured by Olerud and Molander Ankle Score (OMAS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Riegger, MD

CONTACT

[email protected]

0041918117029

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2022
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.