Short and Medium Term Postoperative Complications After Hallux Valgus Surgery (HALLUXVALGUS)
Primary Purpose
Hallux Valgus
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Follow up at 2 years
Sponsored by
About this trial
This is an interventional other trial for Hallux Valgus focused on measuring Hallux Valgus, Complications
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.
Sites / Locations
- Clinique Saint JeanRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient cohorte
Arm Description
Cohort of patients who will benefit from surgical management of their Hallux Valgus with post-operative follow-up at 2 years
Outcomes
Primary Outcome Measures
Onset complication within 1 year after the intervention
Collection of the type of complication and its degree of severity (Clavien Dindo classification)
Secondary Outcome Measures
Evaluation of patient satisfaction
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
collection of the type of complication and its degree of severity (Clavien Dindo classification)
Full Information
NCT ID
NCT04986358
First Posted
July 22, 2021
Last Updated
February 8, 2023
Sponsor
Clinique Saint Jean, France
1. Study Identification
Unique Protocol Identification Number
NCT04986358
Brief Title
Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
Acronym
HALLUXVALGUS
Official Title
Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
January 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Saint Jean, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Hallux Valgus, Complications
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patient cohorte
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient cohorte
Arm Type
Other
Arm Description
Cohort of patients who will benefit from surgical management of their Hallux Valgus with post-operative follow-up at 2 years
Intervention Type
Other
Intervention Name(s)
Follow up at 2 years
Intervention Description
The patients will have a follow-up to carry out 2 years after their intervention in addition to their traditional care
Primary Outcome Measure Information:
Title
Onset complication within 1 year after the intervention
Description
Collection of the type of complication and its degree of severity (Clavien Dindo classification)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of patient satisfaction
Description
satisfaction collected directly from the patient by a self-administered questionnaire : very satisfied, satisfied, not pronounced, dissatisfied or very dissatisfied.
Time Frame
2 years
Title
Onset all complications within 2 years after the intervention
Description
collection of the type of complication and its degree of severity (Clavien Dindo classification)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie SOULIER
Phone
04 67 61 20 71
Ext
+033
Email
julie.soulier@capsante.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayan HEBRARD, MD
Organizational Affiliation
Clinique Saint Jean Sud de France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint Jean
City
Saint-Jean-de-Védas
ZIP/Postal Code
34430
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie SOULIER
Phone
04 67 61 20 71
Ext
+33
Email
julie.soulier@capsante.fr
First Name & Middle Initial & Last Name & Degree
Wayan HEBRARD, MD
12. IPD Sharing Statement
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Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
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