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Static Helical Screw Locking of Pertrochanteric Femur Fractures Using the TFN-A

Study acronym: TFN-A
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 28, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: May 2026 to Jun 2026v5 Show 5 more changesShow less
    • Study completion date: May 2026 to Jan 2027
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints: 8 to 4
    • Study description shortened, about 6 words
    • Site contact updated
  3. Primary and study completion dates: May 2024 to May 2026v4
  4. Primary completion date: May 2022 to May 2024
    • Study completion date: May 2023 to May 2024
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2021 to May 17, 2021
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will investigate the shortening and collapse of pertrochanteric fractures following surgical management with the TFN-Advanced nailing system. The focus will be on comparing radiographic assessments of nails which have been statically locked versus dynamically locked. This is a randomized control study with the initial invention being randomized to either statically locking or dynamically locking. For a two-month period, all eligible patients will receive the randomized allocated treatment, then treatment will switch to the alternate treatment for the next two months and will continue to alternate treatments for two-month periods until study enrollment has completed.
Trial Details
NCT Number NCT04851509
Lead Sponsor Fraser Orthopaedic Research Society
Collaborators: DePuy Synthes
Conditions
(from sponsor)		 Pertrochanteric Fracture
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov