NCT00663351

Safety and Effectiveness Study of the Reflection Ceramic Acetabular System

Post Approval Study: Reflection Ceramic Acetabular System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System. Randomized Non-inflammatory Arthritis, Randomized Inflammatory and Continued Access Cohorts patients previously enrolled in the IDE study will be evaluated annually through five (5) year follow-up. In addition, all patients enrolled in the original study cohorts as well as the continued access patients will be sent a letter questionnaire annually at the 6-10 year postoperative time point to assess the patient's general well-being and if the study components are still in place

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-12-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2008-04-22
• Last updated: 2022-10-13
• Results posted: 2022-10-13

Locations

7 sites across 1 country: United States