An observational study in Foot Deformities, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Completed at 1 site in France. Open to participants aged 6 Months to 2 Years. Per ClinicalTrials.gov, last updated 2022-08-15.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational
Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.
The study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. This collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents.
Early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.
50 studies on the registry are indexed under Foot Deformities; 13 are open to participants now.
This study's enrollment of 76 is close to the median of 84 across 22 observational studies indexed under Foot Deformities.
Browse Foot Deformities studies →GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children who suffered from a congenital idiopathic Z-foot deformation, aged 6 months to 2 years at the time of orthopedic treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention
The main criterion of the study is the success rate of orthopedic management of the Z-foot.
Success is a composite criterion, measured at the last follow-up, defined by: * Outer edge of the straight foot; AND * Absence of dorsolateral hump OR possibility of putting on shoes without difficulty AND * Absence of recurrence of the malformation OR resumption of surgery OR resumption of orthopedic treatment.
Time frame: 9 months
Moderate success rate of the procedure
Defined by an external edge of the foot that is not rectilinear but the possibility of normal footwear, at the greatest distance (relative to the number of feet treated)
Time frame: 9 months
Partial and total success rate (relative to the number of patients treated)
* Total success rate: (number of patients with unilateral involvement and foot treated successfully + number of patients with bilateral involvement and both feet treated successfully) / total number of patients. * Partial success rate in patients with bilateral involvement: number of patients with only one of the 2 feet treated successfully / number of patients with bilateral involvement.
Time frame: 9 months
Convex angle of the outer edge of the foot during follow-up
The evolution of the convexity angle of the external edge of the foot will be studied during treatment and follow-up, in a mixed model with repeated measurements, with the initial severity of the malformation as a cofactor (angle ≤ 15 ° /\> 15 ° ).
Time frame: 9 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Jun 2022, 23 months.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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