Clinical Trial

Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

Study acronym: HARD
Active, Not Recruiting
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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.
Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-10-11; most recent amendment 2024-06-07.
Status change: Recruiting → Active, Not Recruiting 2024-06-07
Status change: Not Yet Recruiting → Recruiting 2021-09-22
Trial Details
NCT Number NCT04590313
Lead Sponsor Hospital District of Helsinki and Uusimaa
Conditions Hallux Rigidus
Enrollment 90 participants
Start Date 2021-09-22
Primary Completion 2025-06-04 (estimated)
Study Completion 2029-06-04 (estimated)
Updated on ClinicalTrials.gov 2024-06-10