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Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement

Study acronym: CRABB-Y
StatusSuspended
PhaseNot applicable
Started2025-01-16
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
critical
Recruitment suspended: Funding for software licensing is no longer available.
Primary completion pushed: 2026-07-01 → 2028-07-01
Completion pushed: 2026-08-01 → 2028-08-01
2025-07-09
minor
Study Status v1
Primary completion date2025-06-01→2026-07-01
Completion date2025-06-01→2026-08-01
2025-01-22
minor
Original filing
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are: Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels? Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.
Trial Details
NCT Number NCT06799377
Lead Sponsor Vanderbilt University Medical Center
Conditions Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
Enrollment 100 participants
Start Date 2025-01-16
Primary Completion 2028-07-01 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-30