Back to results

Treatment of Hallux Rigidus (HARD)

Primary Purpose

Hallux Rigidus

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Arthrodesis

About this trial

This is an interventional treatment trial for Hallux Rigidus focused on measuring surgery, foot, hallux, hallux rigidus, arthrodesis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Helsinki University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arthrodesis

Watchful waiting

Arm Description

MTPJ I Arthrodesis

No intervention, patient information leaflet

Outcomes

Primary Outcome Measures

Pain during walking in Numerical Rating Scale (NRS)

scale 0-10; 0=no pain, 10=worst pain

Secondary Outcome Measures

Pain during rest in Numerical Rating Scale (NRS)

scale 0-10; 0=no pain, 10=worst pain

Pain during walking in Numerical Rating Scale (NRS)

scale 0-10; 0=no pain, 10=worst pain

Patient Related Outcome

MOXFQ-score, Scale 0-100

Patient reported quality of life

EQ-5D-5L, Scale 0-100

Complications

Number of minor and major adversary effects

Patient Acceptable Symptom State

Percentage of patients with acceptable symptom state (PASS)

Patients physical activity

FAAM Sports Subscale, Scale 0-100

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

Full Information

NCT ID

NCT04590313

First Posted

October 5, 2020

Last Updated

September 22, 2021

Sponsor

Hospital District of Helsinki and Uusimaa

1. Study Identification

Unique Protocol Identification Number

NCT04590313

Brief Title

Treatment of Hallux Rigidus

Acronym

HARD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 22, 2021 (Actual)

Primary Completion Date

November 1, 2026 (Anticipated)

Study Completion Date

November 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital District of Helsinki and Uusimaa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hallux Rigidus

Keywords

surgery, foot, hallux, hallux rigidus, arthrodesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

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.

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arthrodesis

Arm Type

Active Comparator

Arm Description

MTPJ I Arthrodesis

Arm Title

Watchful waiting

Arm Type

No Intervention

Arm Description

No intervention, patient information leaflet

Intervention Type

Procedure

Intervention Name(s)

Arthrodesis

Intervention Description

MTPJ I arthrodesis

Primary Outcome Measure Information:

Title

Pain during walking in Numerical Rating Scale (NRS)

Description

scale 0-10; 0=no pain, 10=worst pain

Time Frame

1 year after randomisation

Secondary Outcome Measure Information:

Title

Pain during rest in Numerical Rating Scale (NRS)

Description

scale 0-10; 0=no pain, 10=worst pain

Time Frame

6 months, 1year, 2 years, 5 years

Title

Pain during walking in Numerical Rating Scale (NRS)

Description

scale 0-10; 0=no pain, 10=worst pain

Time Frame

6 months, 2 years, 5 years

Title

Patient Related Outcome

Description

MOXFQ-score, Scale 0-100

Time Frame

6 months, 1year, 2 years, 5 years

Title

Patient reported quality of life

Description

EQ-5D-5L, Scale 0-100

Time Frame

6 months, 1year, 2 years, 5 years

Title

Complications

Description

Number of minor and major adversary effects

Time Frame

6 months, 1year, 2 years, 5 years

Title

Patient Acceptable Symptom State

Description

Percentage of patients with acceptable symptom state (PASS)

Time Frame

6 months, 1year, 2 years, 5 years

Title

Patients physical activity

Description

FAAM Sports Subscale, Scale 0-100

Time Frame

6 months, 1year, 2 years, 5 years

Title

Use of analgesics and orthoses

Description

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

Time Frame

6 months, 1year, 2 years, 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mikko Miettinen, M.D.

Phone

+35894711

mikko.miettinen@hus.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Jussi Repo, M.D., Ph.D.

Phone

+35894711

mrjussirepo@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jussi Repo, M.D., Ph.D.

Organizational Affiliation

Hospital District of Helsinki and Uusimaa

Official's Role

Study Director

Facility Information:

Facility Name

Helsinki University Hospital

City

Helsinki

ZIP/Postal Code

00029 HUS

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mikko Miettinen, M.D.

Phone

+35894711

mikko.miettinen@hus.fi

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34452964

Citation

Miettinen 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.

Results Reference

derived

Learn more about this trial

Treatment of Hallux Rigidus

We'll reach out to this number within 24 hrs