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Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 31, 2027 to Dec 31, 2028
    • Start date: Dec 1, 2025 to Dec 1, 2026
    v6
  2. Site details revisedv5
  3. Primary completion date: Feb 28, 2026 to Dec 31, 2027
    • Start date: Jun 1, 2024 to Dec 1, 2025
    • Study completion date: Feb 28, 2026 to Dec 31, 2028
    • Site details revised
    v4
  4. Secondary endpoints revised (5)v3
  5. Start date: Mar 1, 2024 to Jun 1, 2024
    • Secondary endpoints revised (5)
    • 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus. The main questions it aims to answer are: Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.
Trial Details
NCT Number NCT06262204
Lead Sponsor Orthopedic Hospital Vienna Speising
Conditions
(from sponsor)		 Hallux Valgus
Related terms Hallux Valgus
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov