Evaluating PBS-Score Assessments in Children with Clubfoot
Agreement and Inter-rater Reliability of Video Documented PBS-Score - An International Cross-sectional Multicenter Study
This study is testing how well different orthopedic surgeons agree on the PBS-score assessments for children with clubfoot to make sure the scoring is consistent no matter where the kids are from.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm, Region Stockholm) |
| Trial ID | NCT06033638 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the agreement and inter-rater reliability of PBS-score assessments in children diagnosed with idiopathic clubfoot. A total of 120 children aged 4-14 years will be recruited from four different countries, with each center contributing 30 patients. The study will utilize video recordings to document all items of the PBS-score, which will then be assessed by six to eight senior orthopedic surgeons who are not affiliated with the children's treatment centers. The goal is to ensure a standardized scoring process across diverse geographic locations.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4-14 years with a diagnosis of idiopathic clubfoot who can walk 10 meters and communicate in one of the specified languages.
Not a fit: Patients with non-idiopathic clubfoot or those unable to meet the communication and mobility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the reliability of PBS-score assessments, leading to improved treatment strategies for children with clubfoot.
How similar studies have performed: While this approach of using video documentation for scoring has been utilized in various assessments, the specific application to PBS-scores in clubfoot is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clubfoot Exclusion Criteria: -
Where this trial is running
Stockholm, Region Stockholm
- Astrid Lindgren Children´s Hospital — Stockholm, Region Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Eva W Broström, Professor — Astrid Lindgren Children´s Hospital
- Study coordinator: Josefine E Naili, PhD
- Email: josefine.naili@ki.se
- Phone: +46 123 000 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.