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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
MTPJ I arthrodesis
Helsinki University Hospital
Helsinki, Finland
Pain during walking in Numerical Rating Scale (NRS)
scale 0-10; 0=no pain, 10=worst pain
Time frame: 1 year after randomisation
Pain during rest in Numerical Rating Scale (NRS)
scale 0-10; 0=no pain, 10=worst pain
Time frame: 6 months, 1year, 2 years, 5 years
Pain during walking in Numerical Rating Scale (NRS)
scale 0-10; 0=no pain, 10=worst pain
Time frame: 6 months, 2 years, 5 years
Patient Related Outcome
MOXFQ-score, Scale 0-100
Time frame: 6 months, 1year, 2 years, 5 years
Patient reported quality of life
EQ-5D-5L, Scale 0-100
Time frame: 6 months, 1year, 2 years, 5 years
Complications
Number of minor and major adversary effects
Time frame: 6 months, 1year, 2 years, 5 years
Patient Acceptable Symptom State
Percentage of patients with acceptable symptom state (PASS)
Time frame: 6 months, 1year, 2 years, 5 years
Patients physical activity
FAAM Sports Subscale, Scale 0-100
Time frame: 6 months, 1year, 2 years, 5 years
Use of analgesics and orthoses
The use of analgesics: 1) no use of analgesics or less frequent than weekly, 2) weekly use of analgesics, 3) daily use of NSAIDS or paracetamol, 4) daily use of opioids. The use of orthoses: yes/no
Time frame: 6 months, 1year, 2 years, 5 years
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