Clincosm LogoSign in Get a demo

HALLUXVALGUS: Short and Medium Term Postoperative Complications After Hallux Valgus Surgery

Sponsor
Clinique Saint Jean, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04986358
Collaborator
(none)
400
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Follow up at 2 years
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patient cohortePatient cohorte
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
Actual Study Start Date :
Jan 5, 2022
Anticipated Primary Completion Date :
Jan 5, 2024
Anticipated Study Completion Date :
Jan 5, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Patient cohorte

Cohort of patients who will benefit from surgical management of their Hallux Valgus with post-operative follow-up at 2 years

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Saint Jean Saint-Jean-de-Védas France 34430

Sponsors and Collaborators

  • Clinique Saint Jean, France

Investigators

  • Principal Investigator: Wayan HEBRARD, MD, Clinique Saint Jean Sud de France

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Clinique Saint Jean, France
ClinicalTrials.gov Identifier:
NCT04986358
Other Study ID Numbers:
  • LOCAL2021-WH01
First Posted:
Aug 2, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Clinique Saint Jean, France
Hallux Valgus
Complications
Additional relevant MeSH terms:
Hallux Valgus
Bunion
Postoperative Complications

Study Results

No Results Posted as of Mar 9, 2022