Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hallux Rigidus
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 40 years and 125 years
Gender
Both males and females

Description

Not Provided

Not Provided

Tracking Information

NCT #
NCT04590313
Collaborators
Not Provided
Investigators
Study Director: Jussi Repo, M.D., Ph.D. Hospital District of Helsinki and Uusimaa