Short and Medium Term Postoperative Complications After Hallux Valgus Surgery

Not Applicable

Active, not recruiting

• Conditions: Hallux Valgus
• Interventions: Other: Follow up at 2 years

• Registration Number: NCT04986358
• Lead Sponsor: Clinique Saint Jean, France

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-08-02
• Study Start: 2022-01-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-10-19
• Study Completion: 2025-10-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient cohorte	Follow up at 2 years	Cohort of patients who will benefit from surgical management of their Hallux Valgus with post-operative follow-up at 2 years

Primary Outcome Measures

Name	Time	Method
Onset complication within 1 year after the intervention	1 year	Collection of the type of complication and its degree of severity (Clavien Dindo classification)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Saint Jean; 🇫🇷 Saint-Jean-de-Védas, France