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Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv5
  3. Secondary endpoints: 7 to 10v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 0 to 5
    • Start date changed from estimate of Feb 1, 2021 to May 1, 2021
    • Eligibility criteria revised
    • Secondary endpoints: 6 to 7
    • Study description shortened, about 2 words
  5. Eligibility criteria revised
    • Secondary endpoints revised (6)
    • Study description expanded, about 1 word
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.
Trial Details
NCT Number NCT04664517
Lead Sponsor Helsinki University Central Hospital
Conditions
(from sponsor)		 Both Bone Forearm Fracture, AO Classification 22D/2.1-5.2, 7-12 Year Old
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov