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

Recruiting
Conditions
Clubfoot
Registration Number
NCT06050564
Lead Sponsor
Region Stockholm
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Treatment recommendations1 year

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Astrid Lindgren Children´s Hospital

🇸🇪

Stockholm, Region Stockholm, Sweden

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