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3d printed boot for ctev patients

The Impact of Custom 3D Printed boot for congenital talipes equinovarus correction: A Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085051
Enrollment
50
Registered
2025-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: Q663- Other congenital varus deformitiesof feet

Interventions

Intervention1: 3d printed ctev boot for ctev correction: ctev known as club foot correction of deformity by 3d printed ctev boots study of one year Control Intervention1: conventional ctev boot for

Sponsors

Suresh S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis Children diagnosed with Congenital Talipes Equinovarus (CTEV). Age Infants and children up to 5 years of age. Treatment Stage Suitable for use during both the initial correction phase and the maintenance phase of treatment. Associated Conditions Children with clubfoot associated with other congenital anomalies, provided the brace does not interfere with the treatment of those anomalies. Parental Consent Written consent obtained from parents or legal guardians.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Clubfoot Brace: 1. Severe Medical Conditions: Children with severe systemic illnesses or conditions that contraindicate the use of the brace. 2. Previous Surgical Interventions: Children who have undergone major surgical interventions for clubfoot that render the brace ineffective or unnecessary. 3. Allergies: Known allergy to the materials used in the brace. 4. Compliance Issues: Families unable to comply with the brace s usage and maintenance requirements. 5. Age: Children older than 5 years, unless specifically recommended by an orthopaedic specialist.

Design outcomes

Primary

MeasureTime frame
pirani score improvement ,ankle dorsiflexion angle, time taken to fit bootand number of relapsesTimepoint: baseline, 4 weeks 8 weeks 12weeks

Secondary

MeasureTime frame
Compliance, Clinician-assessed rating of orthosis fitting ,Cost-Effectiveness .Recurrence RateTimepoint: baseline , 4 weeks ,8 weeks ,12 weeks

Countries

India

Contacts

Public Contactdr vijayan b

Saveetha medical college and hospital

sureshaadhav@gmail.com08838740977

Outcome results

None listed

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