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

February 21, 2024 updated by: Ente Ospedaliero Cantonale, Bellinzona

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At the day of surgery, at 6, 12 and 24 weeks postoperatively.
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
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
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.
at 6, 12 and 24 weeks
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.
at 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Investigators

  • Principal Investigator: Martin Riegger, MD, EOC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORL-ORT-033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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