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Treatment of Hallux Rigidus (HARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590313
Recruitment Status : Not yet recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Mikko Miettinen, Hospital District of Helsinki and Uusimaa

Study Description
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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), 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.

Condition or disease Intervention/treatment Phase
Hallux Rigidus Procedure: Arthrodesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: To avoid biased interpretation of the trial data, blinded data interpretation will be used in the reporting of the results of this trial (70). Before accessing the primary outcome data, the writing committee will record a 'Background assumptions' document containing our definition of MID of the outcome measures, and a brief summary of the key statistical analysis used in the evaluation of the outcome data. The document will be signed by the members of the writing committee and published as an appendix to the primary publication.
Primary Purpose: Treatment
Official Title: Treatment of Hallux Rigidus (HARD): A Prospective, Randomised, Controlled Trial of Arthrodesis Versus Watchful Waiting in the Treatment of Hallux Rigidus
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2028
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arthrodesis
MTPJ I Arthrodesis
 Procedure: Arthrodesis
MTPJ I arthrodesis
No Intervention: Watchful waiting
No intervention, patient information leaflet


Outcome Measures
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Primary Outcome Measures :
  1. Pain during walking in Numerical Rating Scale (NRS) [ Time Frame: 1 year after randomisation ]
    scale 0-10; 0=no pain, 10=worst pain


Secondary Outcome Measures :
  1. Pain during rest in Numerical Rating Scale (NRS) [ Time Frame: 6 months, 1year, 2 years, 5 years ]
    scale 0-10; 0=no pain, 10=worst pain

  2. Pain during walking in Numerical Rating Scale (NRS) [ Time Frame: 6 months, 2 years, 5 years ]
    scale 0-10; 0=no pain, 10=worst pain

  3. Patient Related Outcome [ Time Frame: 6 months, 1year, 2 years, 5 years ]
    MOXFQ-score, Scale 0-100

  4. Patient reported quality of life [ Time Frame: 6 months, 1year, 2 years, 5 years ]
    EQ-5D-5L, Scale 0-100

  5. Complications [ Time Frame: 6 months, 1year, 2 years, 5 years ]
    Number of minor and major adversary effects

  6. Patient Acceptable Symptom State [ Time Frame: 6 months, 1year, 2 years, 5 years ]
    Percentage of patients with acceptable symptom state (PASS)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590313


Contacts
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Contact: Mikko Miettinen, M.D. +35894711 mikko.miettinen@hus.fi
Contact: Jussi Repo, M.D., Ph.D. +35894711 mrjussirepo@gmail.com

Locations
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Finland
Helsinki University Hospital
Helsinki, Finland, 00029 HUS
Contact: Mikko Miettinen, M.D.    +35894711    mikko.miettinen@hus.fi   
Sponsors and Collaborators
Hospital District of Helsinki and Uusimaa
Investigators
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Study Director: Jussi Repo, M.D., Ph.D. Hospital District of Helsinki and Uusimaa
More Information
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Responsible Party: Mikko Miettinen, Consultant orthopaedic surgeon, M.D., Hospital District of Helsinki and Uusimaa
ClinicalTrials.gov Identifier: NCT04590313    
Other Study ID Numbers: 39§/30.9.2020
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hallux Rigidus
Hallux Limitus
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
 Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries