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Completed

NCT Number: NCT04986358

Short and Medium Term Postoperative Complications After Hallux Valgus Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint Jean

Saint-Jean-de-Védas, 34430, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Follow up at 2 years

Other

The patients will have a follow-up to carry out 2 years after their intervention in addition to their traditional care

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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. 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)

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Acronym: HALLUXVALGUS

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2021
Registry last updated
Nov 26, 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.

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