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

C

Clinique Saint Jean, France

Status

Completed

Conditions

Hallux Valgus

Treatments

Other: Follow up at 2 years

Study type

Interventional

Funder types

Other

Identifiers

NCT04986358
LOCAL2021-WH01

Details and patient eligibility

About

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.

Full 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.

Enrollment

479 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

479 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Julie SOULIER

Data sourced from clinicaltrials.gov

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