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

Clubfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050564
• Other study ID #: K2022-10587
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Region Stockholm
• Contact: Stephanie Böhm, PhD
• Phone: +46 8123 77644
• Email: stephanie.bohm[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

Intervention

Other:
• Treatment recommendations will be based on video documented PBS-Score
Therapeutic recommendations from orthopedic surgeons, will be summarized and described

Locations

Country	Name	City	State
Sweden	Astrid Lindgren Children´s Hospital	Stockholm	Region Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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