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Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

Study acronym: HARD
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 10, 2024 (before its estimated June 4, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Nov 1, 2026 to Jun 4, 2025v5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 1, 2030 to Jun 4, 2029
    • Site details revised
    • Study title expanded, about 7 words
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Nov 1, 2024 to Nov 1, 2026
    • Study completion date: Nov 1, 2028 to Nov 1, 2030
    • Start date changed from estimate of Oct 1, 2021 to Sep 22, 2021
    • Site details revised
  4. Start date: Nov 1, 2020 to Oct 1, 2021
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 6 to 8
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A randomised, controlled trial will be performed by allocating 40 years or older patients with symptomatic hallux rigidus to arthrodesis or watchful waiting group in a ratio of 1:1. Our primary outcome will be pain during walking, assessed by the 0-10 Numeric Rating Scale (NRS) at one year after randomisation. Our secondary outcomes will be pain in rest (NRS), physical function (MOXFQ), patient satisfaction in terms of Patient-accepted Symptom State (PASS), health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and rate of complications. Our null hypothesis is that there will be no difference between arthrodesis and watchful waiting in treatment of hallux rigidus. Our primary analysis will be done using intention-to-treat principle.
Trial Details
NCT Number NCT04590313
Lead Sponsor Hospital District of Helsinki and Uusimaa
Conditions
(from sponsor)		 Hallux Rigidus
Related terms Ankylosis, Hallux Rigidus
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov