Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 1:25 PM
NCT ID:
NCT01936259
Pre Assignment Details:
Subjects were randomized 1:1 to either the Comprehensive Shoulder System with Nano Humeral Component (Investigational) or the Comprehensive Shoulder System with Mini Humeral Stem (Control). Treatment assignments occurred intraoperatively and subjects remained blinded until completion of two-year follow-up for all subjects.
Recruitment Details:
Due to competitive enrollment, one extra shoulder was randomized and enrolled into the study in the Control group as the site was not aware the study had reached full enrollment.
258 individual subjects were enrolled in the study. 7 subjects underwent study procedures bilaterally, resulting in 265 shoulders enrolled in the study.
Type Units Analyzed:
Shoulders
Study:
NCT01936259
Study Brief:
Results Section:
NCT01936259