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

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ClinicalTrials.gov Identifier: NCT04986358
Recruitment Status : Not yet recruiting
First Posted : August 2, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Clinique Saint Jean, France

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
Hallux Valgus Other: Follow up at 2 years Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patient cohorte
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Short and Medium Term Postoperative Complications After Hallux Valgus Surgery
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: After Surgery

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluation of patient satisfaction [ Time Frame: 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 [ Time Frame: 2 years ]
    collection of the type of complication and its degree of severity (Clavien Dindo classification)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04986358


Contacts
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Contact: Julie SOULIER 04 67 61 20 71 ext +033 julie.soulier@capsante.fr

Sponsors and Collaborators
Clinique Saint Jean, France
Investigators
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Principal Investigator: Wayan HEBRARD, MD Clinique Saint Jean Sud de France
Publications:

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Responsible Party: Clinique Saint Jean, France
ClinicalTrials.gov Identifier: NCT04986358    
Other Study ID Numbers: LOCAL2021-WH01
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021

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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:
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Hallux Valgus
Bunion
Postoperative Complications
Pathologic Processes
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired