Treatment of Hallux Rigidus (HARD)

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

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 Overview

• Status: Recruiting
• Conditions: Hallux Rigidus
• Intervention / Treatment: Procedure: Arthrodesis

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikko Miettinen, M.D.; Phone Number: +35894711; Email: mikko.miettinen@hus.fi
• Study Contact Backup: Name: Jussi Repo, M.D., Ph.D.; Phone Number: +35894711; Email: mrjussirepo@gmail.com

Study Locations

• Finland
  • Helsinki, Finland, 00029 HUS
    • Recruiting
    • Helsinki University Hospital
    • Contact: Mikko Miettinen, M.D.; Phone Number: +35894711; Email: mikko.miettinen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arthrodesis; MTPJ I Arthrodesis	Procedure: Arthrodesis; MTPJ I arthrodesis
No Intervention: Watchful waiting; No intervention, patient information leaflet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital District of Helsinki and Uusimaa
• Investigators: Study Director: Jussi Repo, M.D., Ph.D., Hospital District of Helsinki and Uusimaa

Publications and helpful links

General Publications

• Miettinen M, Ramo L, Lahdeoja T, Sirola T, Sandelin H, Ponkilainen V, Repo JP. 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. BMJ Open. 2021 Aug 27;11(8):e049298. doi: 10.1136/bmjopen-2021-049298.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: surgery; arthrodesis; hallux rigidus; foot; hallux
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: 39§/30.9.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No