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A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jul 1, 2026 → Jul 1, 2028
See other at-risk trials from Ente Ospedaliero Cantonale, Bellinzona

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 1, 2026 to Jul 1, 2028v8
  2. Primary and study completion dates: Jul 1, 2025 to Jul 1, 2026v7
  3. Primary completion date: Jan 1, 2025 to Jul 1, 2025v6
  4. Primary completion date: Jan 1, 2024 to Jan 1, 2025
    • Study completion date: Jan 1, 2025 to Jul 1, 2025
    v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2023 to Jan 19, 2023
    • Site details revised
    v3
  2. Enrollment target: 70 to 122v2 Show 6 more changesShow less
    • Start date: Oct 1, 2022 to Jan 1, 2023
    • Primary endpoint revised
    • Primary completion date: Oct 1, 2023 to Jan 1, 2024
    • Study completion date: Oct 1, 2024 to Jan 1, 2025
    • Secondary endpoints revised (4)
    • Site contact updated
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.
Trial Details
NCT Number NCT05534724
Lead Sponsor Ente Ospedaliero Cantonale, Bellinzona
Conditions
(from sponsor)		 Hallux Valgus, Orthopedic Disorder
Related terms Hallux Valgus, Musculoskeletal Diseases
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov