Trials / Active Not Recruiting
Active Not RecruitingNCT04590313
Efficacy of First MTPJ Arthrodesis as a Treatment in Hallux Rigidus
Treatment of Hallux Rigidus (HARD): A Prospective, Randomised, Controlled Trial of Arthrodesis Versus Watchful Waiting in the Treatment of Hallux Rigidus
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Hospital District of Helsinki and Uusimaa · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Arthrodesis | MTPJ I arthrodesis |
Timeline
- Start date
- 2021-09-22
- Primary completion
- 2025-06-04
- Completion
- 2029-06-04
- First posted
- 2020-10-19
- Last updated
- 2024-06-10
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT04590313. Inclusion in this directory is not an endorsement.