Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus

Hallux Rigidus Clinical Trial

— HARD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04590313
• Other study ID #: 39§/30.9.2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: June 4, 2029

Study information

• Verified date: June 2024
• Source: Hospital District of Helsinki and Uusimaa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 4, 2029
• Est. primary completion date: June 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Intervention

Procedure:
• Arthrodesis
MTPJ I arthrodesis

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa

Country where clinical trial is conducted

Finland, 

Outcome

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