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ACTIVE NOT RECRUITING
NCT04590313
NA

Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

Sponsor: Hospital District of Helsinki and Uusimaa

View on ClinicalTrials.gov

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.

Official title: Treatment of Hallux Rigidus (HARD): A Prospective, Randomised, Controlled Trial of Arthrodesis Versus Watchful Waiting in the Treatment of Hallux Rigidus

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2021-09-22

Completion Date

2029-06-04

Last Updated

2024-06-10

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Arthrodesis

MTPJ I arthrodesis

Locations (1)

Helsinki University Hospital

Helsinki, Finland