At a glance
ClinicalIndex Comparison RecordN/ACompleted· 479 enrolled
Drug / intervention
Total Hip Arthroplastydevice
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 Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3◊ Acetabular System in Patients With Degenerative Hip Disease
In Brief
An observational study evaluating Total Hip Arthroplasty for Degenerative Joint Disease. Completed, enrolled 479 participants across 8 sites in 7 countries.
Detailed Summary
The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Joint Disease
CountriesBelgium, Denmark, Finland, Germany, Netherlands, Spain, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2020
Primary CompletionFeb 2022
Study CompletionApr 2022
TodayJul 2026
First PostedMay 22, 2020
Enrollment StartMay 18, 2009
Primary CompletionFeb 18, 2022
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 12.8 yearsPosted 6.1 years ago
Interventions
Total Hip Arthroplastydevice
Total hip arthroplasty with the R3 Acetabular Hip system.