Safety and Effectiveness Study of the Reflection Ceramic Acetabular System

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.

Conditions

• Osteoarthritis

Interventions

DEVICE

Reflection Ceramic-Ceramic Total Hip Replacement

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.

DEVICE

Reflection FSO V Total Hip Replacement

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.

Sponsors & Collaborators

• Smith & Nephew, Inc.

  lead INDUSTRY

Principal Investigators

• Scott Corpe, M.D. · Medical College of Georgia, Dept of Orthopaedic

• Joseph Zuckerman, M.D. · Hospital of Joint Disease, Orthopaedic Institute

• Jonathan P Garino, M.D. · Presbyterian Medical Center, Dept of Orthopaedic

• Michael J Grecula, M.D. · University of Texas Medical Branch, Dept of Orthopaedic

• James Howe, M.D. · University of Vermont

• Michael Lynch, M.D. · The Memphis Orthopaedic Group, PC

• Norman E Walter, M.D. · Family Orthopaedics

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-12-31

Primary Completion

2014-10-31

Completion

2014-12-31

Countries

• United States

Study Locations