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Clinical Trials/NCT04986358
NCT04986358
Completed
Not Applicable

Short and Medium Term Postoperative Complications After Hallux Valgus Surgery

Clinique Saint Jean, France1 site in 1 country479 target enrollmentJanuary 5, 2022
ConditionsHallux Valgus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hallux Valgus
Sponsor
Clinique Saint Jean, France
Enrollment
479
Locations
1
Primary Endpoint
Onset complication within 1 year after the intervention
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2022
End Date
October 19, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Clinique Saint Jean, France
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

  • Evaluation of patient satisfaction(2 years)
  • Onset all complications within 2 years after the intervention(2 years)

Study Sites (1)

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