Q66.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Infants with congenital unilateral or bilateral pes equinovarus deformity - No prior conservative or surgical treatment has been performed (short-term physiotherapy or bandaging may have been done previously) - Age under 4 months
Exclusion criteria
Exclusion criteria: - Previous clubfoot treatment following a different concept - Foot surgeries performed prior to the start of the study - Legal guardians declining participation - Infants beginning treatment after the start of the 4th month of life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The thigh-high clubfoot orthosis is equivalent to the foot abduction orthosis (ALFA-Flex) in terms of its effectiveness in preventing recurrence of congenital clubfoot. - The thigh-high clubfoot orthosis is equivalent to the foot abduction orthosis (ALFA-Flex) in terms of its effectiveness in preventing recurrence of neurological/syndromal clubfoot. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Compliance, and thus the reduction of recurrences, is higher with the thigh-high clubfoot orthosis than with the foot abduction orthosis (ALFA-Flex). - Motor development is the same in both cohorts. - Quality of life is higher with a thigh-high clubfoot orthosis than with a foot abduction orthosis (ALFA-Flex). - Treatment costs and treatment efforts are similar with both orthoses. | — |
Countries
Germany
Contacts
BG Klinik Ludwigshafen