CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled
Drug / intervention
Not specified
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.

Search/NCT03566082
NCT03566082N/ACompleted
CompareCT.gov

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

Smith & Nephew Orthopaedics AG·observational·Posted Jun 21, 2018·Updated May 30, 2024

In Brief

An observational study for Degenerative Joint Disease of Hip. Completed, enrolled 135 participants across 5 sites in 4 countries.

Detailed Summary

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Joint Disease of Hip
CountriesBelgium, Finland, Spain, United Kingdom
CollaboratorseResearchTechnology, Inc, M Squared Associates, Inc., ExecuPharm PAREXEL, IQVIA Pty Ltd

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2018
Enrollment StartMay 28, 2009
Primary CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 8.0 years ago