Clinical trial NCT04986358: Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
Official title: Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hallux Valgus
Keywords: Hallux Valgus
Complications
Lead sponsor: Clinique Saint Jean, France
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient cohorte
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Onset complication within 1 year after the intervention
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of patient satisfaction
timeFrame: 2 years
measure: Onset all complications within 2 years after the intervention
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint-Jean-de-Védas
country: France
facility: Clinique Saint Jean
Study officials:
affiliation: Clinique Saint Jean Sud de France
name: Wayan HEBRARD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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