NCT06050746

Brief Summary

Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
51mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jan 2023Jun 2030

Study Start

First participant enrolled

January 10, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

7.5 years

First QC Date

September 11, 2023

Last Update Submit

September 12, 2025

Conditions

Clubfoot

Keywords

PBS-scoreOxford Foot and Ankle Questionaire-childRoye's scorePedobarography

Outcome Measures

Primary Outcomes (1)

  • Need for further treatment

    total number of casting, type of braces and/or choice of orthopedic surgery

    5 years

Secondary Outcomes (2)

  • Patient reported outcome measures (PROM)

    5 years

  • Patient reported outcome measures - The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child - or parent (proxy)

    5 years

Interventions

Systematic screeningOTHER

Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.

Also known as: PBS-score, video evaluation, PROM, dynamic foot pressure

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with idopatic clubfoot treated at Astrdi lindgren Children´s Hospital

You may qualify if:

  • age 4-10 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English.

You may not qualify if:

  • Syndromic clubfoot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Astrid Lindgren Children´s Hospital

Stockholm, Region Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Eva W Broström, Professor

    Astrid Lindgren Children´s Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 22, 2023

Study Start

January 10, 2023

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)