Recommendations for treating clubfoot based on clinical history and PBS-score
Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score, an International Cross-sectional Multicenter Study
This study looks at how doctors use a scoring system and patient history to decide the best treatment for children with clubfoot.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 4 Years to 14 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm, Region Stockholm) |
| Trial ID | NCT06050564 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between the PBS-score and treatment recommendations made by experienced pediatric orthopedic surgeons. The study will involve collecting treatment recommendations from six to eight surgeons across four countries, based on video documented PBS-score items and detailed patient histories. Key factors considered will include the child's age, Pirani score, initial treatment needs, and compliance with orthotic use. The goal is to enhance understanding of how clinical history and scoring can inform treatment decisions for clubfoot.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with idiopathic clubfoot who can walk 10 meters and communicate in one of the specified languages.
Not a fit: Patients with syndromic clubfoot will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and effective treatment recommendations for children with clubfoot.
How similar studies have performed: While there may be studies focusing on treatment recommendations for clubfoot, this specific approach using the PBS-score and video documentation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
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: Stephanie Böhm, PhD
- Email: stephanie.bohm@regionstockholm.se
- Phone: +46 8123 77644
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.