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Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Jun 1, 2025
    • Study sites: 0 to 1
    v4
  2. Notable Start date: Mar 2024 to Oct 2024
    • Study description revised
    v3
  3. Notable Start date: Jan 2024 to Mar 2024
    • Primary completion date: Jan 2028 to Mar 2028
    • Study completion date: Jan 2030 to Mar 2030
    • Secondary endpoints: details revised at 2 of 3 entries
    v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized controlled trial is to investigate operative treatment versus conservative treatment in participants suffering from mild to moderate hallux valgus deformity. The main question it aims to answer are; Is surgery superior to conservative treatment? The participants will be randomized in to two groups, operative and conservative group. Investigators will compare the groups measuring the clinical results using the patient-reported outcome measure (PROM) Manchester-Oxford Foot Questionnaire (MOxFQ), Visual analog scale (VAS), likert scale 0-5. Participants will be observed for a period og two years.
Trial Details
NCT Number NCT06114043
Lead Sponsor Ostfold Hospital Trust
Conditions
(from sponsor)
Hallux Valgus Deformity
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov