Treatment of Hallux Rigidus

Study Overview
=================
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.

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

Conditions
-----------------
Hallux Rigidus

Intervention / Treatment
-----------------
* Procedure: Arthrodesis


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthrodesis<br>MTPJ I Arthrodesis | Procedure: Arthrodesis<br>* MTPJ I arthrodesis<br>|
| No Intervention: Watchful waiting<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, foot, hallux, hallux rigidus, arthrodesis