NCT04590313: HARD

Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

Active, enrolled NA Last updated 10 June 2024

What this trial tests

NA trial testing Arthrodesis in Hallux Rigidus in 90 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 September 2021

Primary endpoint
4 June 2025

4 June 2029

Quick facts

Lead sponsor	Hospital District of Helsinki and Uusimaa
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	90
Start date	22 September 2021
Primary completion	4 June 2025
Estimated completion	4 June 2029
Sites	1 location across Finland

Drugs / interventions tested

• Arthrodesis

Conditions studied

• Hallux Rigidus — all drugs for Hallux Rigidus →

Sponsor

Hospital District of Helsinki and Uusimaa

Who can join

40 and older, any sex, with Hallux Rigidus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of hallux rigidus (HARD trial): study protocol of a prospective, randomised, controlled trial of arthrodesis versus watchful waiting in the treatment of a painful osteoarthritic first metatarsophalangeal joint.
   Miettinen M, Rämö L, Lähdeoja T, Sirola T, et al · · 2021 · cited 1× · PMID 34452964 · DOI 10.1136/bmjopen-2021-049298