Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score

NCT06050564 | Completed

• 1 other identifier: K2022-10587
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the relationship between the PBS-score and treatment recommendations provided by senior pediatric orthopedic surgeons.

Conditions

Clubfoot

Keywords

PBS-score; PEVA; Treatment clubfoot

Outcome Measures

Primary Outcomes (1)

• Treatment recommendations

  Treatment recommendations from eight to ten experienced pediatric orthopedic surgeons will be collected. Their recommendations will be based on the included items of the Pirani Böhm Sinclair, PBS-score, the lowest score with 7 points being the best and 18 points the worst. The patient history including age of the child, Pirani score minimum 0 and maximum score is 6, the higher, the more severe deformity. Initial treatment (need for Achilles tenotomy), and reported compliance to orthotic use.

  1 year

Interventions

Treatment recommendations will be based on video documented PBS-Score OTHER

Therapeutic recommendations from orthopedic surgeons, will be summarized and described

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

120 children with idiopathic clubfoot will be included from four different countries

You may qualify if:

• diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto.

You may not qualify if:

• syndromic clubfoot

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Astrid Lindgren Children´s Hospital

Stockholm, Region Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, 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: CROSS SECTIONAL
• 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: December 28, 2023
• Study Completion: June 18, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)