Short and Medium Term Postoperative Complications After Hallux Valgus Surgery (HALLUXVALGUS)

November 21, 2025 updated by: Clinique Saint Jean, France
The aim of this study is to make a precise inventory of the complications that may occur postoperatively in the more or less long term in a cohort of patients who should benefit from surgical management of Hallux Valgus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hallux Valgus surgery is one of the most common foot surgeries. The surgical procedure itself has evolved a lot and is now, in almost all cases, on an outpatient basis with greatly improved pain management.

However, various postoperative complications, more or less severe and more or less long term, can worsen the final result. The literature describing these complications comes mainly from meta-analysis, retrospective studies or studies targeting a particular type of complications.

As a result, there are few complete and objective descriptions of these complications.

In addition, studies reporting postoperative consequences always assess the "serious" long-term complications responsible for a poor functional outcome, primarily the recurrence of the initial deformity, defined as surgical failure. It seemed relevant to try to assess early complications, "less serious", not necessarily worsening the final result but directly impacting the postoperative recovery period.

The evaluation of this recovery period and the length of time off work based on these "less severe" complications could improve the quality of surgical management of hallux valgus.

This is why it seemed interesting to carry out a precise inventory of the complications that may occur postoperatively in the more or less long term in a cohort of patients.

Study Type

Interventional

Enrollment (Actual)

479

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 Locations

  • France
      • Saint-Jean-de-Védas, France, 34430
        • Clinique Saint Jean

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with medical insurance.
  • Patient who recieved information about study and signes a consent to participate in the study.
  • Major patient requiring surgical management of a Hallux Valgus.

Exclusion Criteria:

  • Minor patient.
  • Patient participating in another interventional study.
  • Patient with one of the following pathologies: Rheumatoid arthritis, haemophilia, inflammatory rheumatism or neurological spasticity.
  • Patient to undergo a one-step bilateral Hallux Valgus surgical treatment (surgery of both feet on the same day).
  • Patient refusing to sign the consent form.
  • Patient for whom it is impossible to give informed information.
  • Patient under the protection of justice, under curatorship ou under tutorship.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient cohorte
Cohort of patients who will benefit from surgical management of their Hallux Valgus with post-operative follow-up at 2 years
Other: Follow up at 2 years
The patients will have a follow-up to carry out 2 years after their intervention in addition to their traditional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset complication within 1 year after the intervention
Time Frame: 1 year
Collection of the type of complication and its degree of severity (Clavien Dindo classification)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of patient satisfaction
Time Frame: 2 years
satisfaction collected directly from the patient by a self-administered questionnaire : very satisfied, satisfied, not pronounced, dissatisfied or very dissatisfied.
2 years
Onset all complications within 2 years after the intervention
Time Frame: 2 years
collection of the type of complication and its degree of severity (Clavien Dindo classification)
2 years

Collaborators and Investigators

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

Sponsor

Clinique Saint Jean, France

Investigators

  • Principal Investigator: Wayan HEBRARD, MD, Clinique Saint Jean Sud de France

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

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 5, 2022

Primary Completion (Actual)

October 19, 2024

Study Completion (Actual)

October 19, 2025

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

July 23, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL2021-WH01

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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