Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus (NCT04590313) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus
Finland90 participantsStarted 2021-09-22
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 questi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain during walking in Numerical Rating Scale (NRS)