Safety and Effectiveness Study of the Reflection Ceramic Acetabular System

NACompletedINTERVENTIONAL
Enrollment

456

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2014

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.

Trial Locations (7)

10003

Hospital of Joint Disease, Orthopaedic Institute, New York

30912

Medical College of Georgia, Department of Orthopaedics, Augusta

38104

The Memphis Orthopaedic Group, PC, Memphis

48507

Family Orthopaedics, Flint

77555

University of Texas Medical Branch, Dept of Orthopaedics and Rehab, Galveston

19104-2699

Presbyterian Medical Center, Department of Orthopaedic Surgery, Philadelphia

05405

University of Vermont College of Medicine, Burlington

All Listed Sponsors
lead

Smith & Nephew, Inc.

INDUSTRY