Hallux RigidusHARDNCT04590313
Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus
A study testing Arthrodesis in people with Hallux Rigidus, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hallux Rigidus
- What is being tested?
- Arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- 22 Sep 2021to 4 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hallux Rigidus
- Being tested
- Arthrodesis
- Keywords
- surgery, foot, hallux, hallux rigidus, arthrodesis
- Medical subject headings
- Hallux Rigidus, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrodesisProcedure or surgery
MTPJ I arthrodesis
| Study group | Role | What they receive |
|---|---|---|
| Arthrodesis | Active comparator | MTPJ I Arthrodesis Receives: Procedure: Arthrodesis |
| Watchful waiting | No intervention | No intervention, patient information leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during walking in Numerical Rating Scale (NRS)
scale 0-10; 0=no pain, 10=worst pain
Measured: 1 year after randomisation
Secondary outcomes (8)
Pain during rest in Numerical Rating Scale (NRS)
scale 0-10; 0=no pain, 10=worst pain
Measured: 6 months, 1year, 2 years, 5 years
Pain during walking in Numerical Rating Scale (NRS)
scale 0-10; 0=no pain, 10=worst pain
Measured: 6 months, 2 years, 5 years
Patient Related Outcome
MOXFQ-score, Scale 0-100
Measured: 6 months, 1year, 2 years, 5 years
Patient reported quality of life
EQ-5D-5L, Scale 0-100
Measured: 6 months, 1year, 2 years, 5 years
Complications
Number of minor and major adversary effects
Measured: 6 months, 1year, 2 years, 5 years
Patient Acceptable Symptom State
Percentage of patients with acceptable symptom state (PASS)
Measured: 6 months, 1year, 2 years, 5 years
Patients physical activity
FAAM Sports Subscale, Scale 0-100
Measured: 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
Measured: 6 months, 1year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start22 Sep 2021
- Primary completion4 Jun 2025 (estimated)
- Study completion4 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hallux RigidusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital District of Helsinki and Uusimaa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikko Miettinen, Hospital District of Helsinki and Uusimaa
- Investigators
- Jussi Repo, M.D., Ph.D., Study director, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590313
- Sponsor's protocol ID
- 39§/30.9.2020
- Acronym
- HARD
- Status last verified
- Jun 2024
- First submitted
- 5 Oct 2020
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miettinen M, Sirola T, Lahdeoja T, Sandelin H, Nummela M, Repo JP, Ponkilainen V, Ramo L. Surgery Versus Watchful Waiting for First Metatarsophalangeal Joint Osteoarthritis : A Randomized Controlled Trial. Ann Intern Med. 2026 Aug 11. doi: 10.7326/ANNALS-26-00710. Online ahead of print.
PubMed 42574728Miettinen 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.
PubMed 34452964
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hallux Rigidus (HARD): A Prospective, Randomised, Controlled Trial of Arthrodesis Versus Watchful Waiting in the Treatment of Hallux Rigidus
- ClinicalTrials.gov ID
- NCT04590313
- Acronym / sponsor ID
- HARD / 39§/30.9.2020
- Conditions
- Hallux Rigidus
- Keywords
- surgery, foot, hallux, hallux rigidus, arthrodesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital District of Helsinki and UusimaaUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 4 Jun 2025 (estimated)
- Study completion
- 4 Jun 2029 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arthrodesis | Active comparator | Procedure: ArthrodesisMTPJ I Arthrodesis |
| Watchful waiting | No intervention | –No intervention, patient information leaflet |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthrodesisMTPJ I arthrodesis | Procedure or surgery | Arthrodesis |
Primary outcome
Pain during walking in Numerical Rating Scale (NRS)
Time frame: 1 year after randomisation
scale 0-10; 0=no pain, 10=worst pain
8 secondary outcomes
Pain during rest in Numerical Rating Scale (NRS)
Time frame: 6 months, 1year, 2 years, 5 years
Pain during walking in Numerical Rating Scale (NRS)
Time frame: 6 months, 2 years, 5 years
Patient Related Outcome
Time frame: 6 months, 1year, 2 years, 5 years
Patient reported quality of life
Time frame: 6 months, 1year, 2 years, 5 years
Complications
Time frame: 6 months, 1year, 2 years, 5 years
Patient Acceptable Symptom State
Time frame: 6 months, 1year, 2 years, 5 years
Patients physical activity
Time frame: 6 months, 1year, 2 years, 5 years
Use of analgesics and orthoses
Time frame: 6 months, 1year, 2 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Derived from this study: PubMed 42574728Miettinen M, Sirola T, Lahdeoja T, Sandelin H, Nummela M, Repo JP, Ponkilainen V, Ramo L. Surgery Versus Watchful Waiting for First Metatarsophalangeal Joint Osteoarthritis : A Randomized Controlled Trial. Ann Intern Med. 2026 Aug 11. doi: 10.7326/ANNALS-26-00710. Online ahead of print.
- Derived from this study: PubMed 34452964Miettinen 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.
- Individual participant dataSharing planned: No
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Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jussi Repo, M.D., Ph.D. study director
Hospital District of Helsinki and Uusimaa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrodesis in people with Hallux Rigidus, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during walking in Numerical Rating Scale (NRS) (time frame: 1 year after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04590313, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.