Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

Not Applicable

Active, not recruiting

• Conditions: Hallux Rigidus

• Registration Number: NCT04590313
• Lead Sponsor: Hospital District of Helsinki and Uusimaa

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-11
• Study First Posted: 2020-10-19
• Study Start: 2021-09-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-06-04
• Study Completion: 2029-06-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain during walking in Numerical Rating Scale (NRS)	1 year after randomisation	scale 0-10; 0=no pain, 10=worst pain

Secondary Outcome Measures

Name	Time	Method
Pain during rest in Numerical Rating Scale (NRS)	6 months, 1year, 2 years, 5 years	scale 0-10; 0=no pain, 10=worst pain
Complications	6 months, 1year, 2 years, 5 years	Number of minor and major adversary effects
Patients physical activity	6 months, 1year, 2 years, 5 years	FAAM Sports Subscale, Scale 0-100
Use of analgesics and orthoses	6 months, 1year, 2 years, 5 years	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
Patient reported quality of life	6 months, 1year, 2 years, 5 years	EQ-5D-5L, Scale 0-100
Patient Acceptable Symptom State	6 months, 1year, 2 years, 5 years	Percentage of patients with acceptable symptom state (PASS)
Patient Related Outcome	6 months, 1year, 2 years, 5 years	MOXFQ-score, Scale 0-100
Pain during walking in Numerical Rating Scale (NRS)	6 months, 2 years, 5 years	scale 0-10; 0=no pain, 10=worst pain

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland