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

Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score, an International Cross-sectional Multicenter Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06050564
Enrollment
55
Registered
2023-09-22
Start date
2023-01-10
Completion date
2024-06-18
Last updated
2025-09-15

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

Conditions

Clubfoot

Keywords

PBS-score, PEVA, Treatment clubfoot

Brief summary

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

Detailed description

In conjunction with the assessments of video documented PBS-score items (described in Study I), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. Their recommendations will be based on the included items of the PBS-score, and patient history including age of the child, Pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.

Interventions

OTHERTreatment recommendations will be based on video documented PBS-Score

Therapeutic recommendations from orthopedic surgeons, will be summarized and described

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
4 Years to 14 Years

Inclusion criteria

* 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.

Exclusion criteria

* syndromic clubfoot

Design outcomes

Primary

MeasureTime frameDescription
Treatment recommendations1 yearTreatment 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 26, 2026