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
|Condition or disease||Intervention/treatment||Phase|
|Hallux Valgus||Other: Follow up at 2 years||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patient cohorte|
|Masking:||None (Open Label)|
|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|
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
- 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)
- 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.
- 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)
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
|Contact: Julie SOULIER||04 67 61 20 71 ext +email@example.com|
|Principal Investigator:||Wayan HEBRARD, MD||Clinique Saint Jean Sud de France|