Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus
ConditionClub Foot
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorAssiut University
About this trial
Epiphysiodesis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients are eligible for participation in the study if
Age between 5 to 10 years old
Relapsed idiopathic clubfoot (CTEV)
Presence of residual metatarsal adductus
Disqualifiers
Patients are excluded for participation in the study if
Teratologic clubfoot (e.g., myelomeningocele).
Children under 4 years of mild severity that could be corrected with conservative treatment, or above 10 years old.
flexible (correctable) deformity of the foot.
Trial design
Design model
Sequential
Treatments tested in this trial
Midfoot Osteotomy
Procedure/SurgeryGroup 1 Immobilization in along leg (above knee cast) for 6 weeks Non-weight bearing during casting period Cast removal followed by gradual return to weight bearing
8-Plate Epiphysiodesis
Procedure/SurgeryNO immobilization, only protective splinting for 2 weeks as postoperative rest, after splint removal return to normal activity. Plate will be removed after full clinical and radiological correction. Further procedures e.g. tibalis anterior tendon transfer can be done as needed.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Midfoot OsteotomyActive comparator 1 intervention
Group B: 8-Plate EpiphysiodesisActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To compare the results of the two technical procedures of surgical treatment by Radiological correction
radiological correction assessed using the Demiglio score to evaluate the outcome of the two surgical techniques.
Time frame
6 months after surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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