At a glance
ClinicalIndex Comparison RecordN/ACompleted· 137 enrolled
Drug / intervention
PyroTITAN™ HRAdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical and Radiological Study to Evaluate the Safety and Efficacy of the PyroTITAN Humeral Resurfacing Arthroplasty (HRA) Device in a New Cohort of Patients After Product Re-Release
In Brief
An observational study evaluating PyroTITAN™ HRA for Arthritis. Completed, enrolled 137 participants across 1 site.
Detailed Summary
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis
CountriesAustralia
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedDec 2016
Primary CompletionFeb 2023
TodayJul 2026
First PostedDec 6, 2016
Enrollment StartOct 1, 2016
Primary CompletionFeb 8, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.6 years ago
Interventions
PyroTITAN™ HRAdevice
Humeral Resurfacing