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Prospective randomized study on modified Ponseti method for clubfoot

Prospective randomized study on modified Ponseti method for clubfoot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035368
Enrollment
80
Registered
2024-10-29
Start date
2023-11-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q66.0

Interventions

Group 1: Patient recruitment takes place through our pediatric orthopedic specialty clinic. The patients who present are divided into two groups: neurologically healthy children with congenital clubfo

Sponsors

Orthopädische Universitätsklinik Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Months to 4 Months

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

MeasureTime 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

MeasureTime 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

Public ContactJannes Kreher

BG Klinik Ludwigshafen

jannes.kreher@bgu-ludwigshafen.de004962168108833

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026