CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 456 enrolled
Drug / intervention
Reflection Ceramic-Ceramic Total Hip Replacement +1 moredevice
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/NCT00663351
NCT00663351N/ACompleted
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Post Approval Study: Reflection Ceramic Acetabular System

Smith & Nephew, Inc.·interventional·Posted Apr 22, 2008·Updated Oct 13, 2022

In Brief

A clinical study evaluating Reflection Ceramic-Ceramic Total Hip Replacement and Reflection FSO V Total Hip Replacement for Osteoarthritis. Completed, enrolled 456 participants across 7 sites.

Detailed Summary

This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2008
Enrollment StartDec 1, 2004
Primary CompletionOct 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 18.2 years ago

Interventions

Reflection Ceramic-Ceramic Total Hip Replacementdevice

Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.

Reflection FSO V Total Hip Replacementdevice

Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.