Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus (HARD)

Hospital District of Helsinki and Uusimaa

Status

Active, not recruiting

Conditions

Hallux Rigidus

Treatments

Procedure: Arthrodesis

Study type

Interventional

Funder types

Other

Identifiers

NCT04590313

39§/30.9.2020

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 40 years or over
Diagnosis of hallux rigidus: Persistent pain on movement of the first MTPJ AND Osteoarthritic first MTPJ in plain X-rays
Duration of symptoms ≥1 year
Pain-NRS during walking of 4 or more on a scale 0-10 (higher is worse)
No substantial pain in other joints of the foot in clinical examination
Willingness to accept both treatment options
Ability to understand trial information and answer outcome assessments in Finnish
Signed informed consent

Exclusion criteria

ASA* physical status classification level III or higher
Patients with weak co-operation (dementia, schizophrenia, etc.)
Patients with neuropathy, i.e. unable to feel 10g monofilament pressure in less than 8 out of 10 standard testing sites
Active bacterial infection or ulcer of the lower limb
Diabetes mellitus with insulin treatment
Diabetes mellitus and GHb-A1C >64 mmol/mol (regardless of treatment)
History of rheumatoid arthritis, gout or other inflammatory arthritis of the foot
Hallux valgus angle >15° in weight-bearing X-ray
Hallux varus in weight-bearing X-ray
Large bone cysts in X-ray probably requiring bone grafting in surgery
Pain in passive manipulation of ipsilateral first toe IP joint
Patients with severe circulatory disorder of the lower limb: absence of palpable pulses in the foot (both dorsalis pedis artery and tibialis posterior artery)
History of surgery of the foot in question
Neuropathic pain of the foot in question (i.e., use of neuropathic analgesics)
Activity limiting symptoms from an earlier fracture or ligament injury of the foot
Patient is not willing to accept the operation within the planned time limits (3 to 12 weeks post-randomisation)