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Sponsored by: |
Smith & Nephew, Inc. |
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Information provided by: | Smith & Nephew, Inc. |
ClinicalTrials.gov Identifier: | NCT00663351 |
This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System.
Condition | Intervention | Phase |
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Osteoarthritis |
Device: Reflection Ceramic-Ceramic Total Hip Replacement Device: Reflection FSO V Total Hip Replacement |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Post Approval Study: Reflection Ceramic Acetabular System |
Estimated Enrollment: | 345 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
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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.
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2: Active Comparator
Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.
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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.
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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
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
(Patient must meet all of the following characteristics to be enrolled in the study):
Exclusion Criteria:
(Patient with any of the following characteristics must be excluded from the study):
United States, Georgia | |
Medical College of Georgia, Department of Orthopaedics | |
Augusta, Georgia, United States, 30912 | |
United States, Michigan | |
Family Orthopaedics | |
Flint, Michigan, United States, 48507 | |
United States, New York | |
Hospital of Joint Disease, Orthopaedic Institute | |
New York, New York, United States, 10003 | |
United States, Pennsylvania | |
Presbyterian Medical Center, Department of Orthopaedic Surgery | |
Philadelphia, Pennsylvania, United States, 19104-2699 | |
United States, Tennessee | |
The Memphis Orthopaedic Group, PC | |
Memphis, Tennessee, United States, 38104 | |
United States, Texas | |
University of Texas Medical Branch, Dept of Orthopaedics and Rehab | |
Galveston, Texas, United States, 77555 | |
United States, Vermont | |
University of Vermont College of Medicine | |
Burlington, Vermont, United States, 05405 |
Responsible Party: | Smith & Nephew, Inc. ( Joan Overhauser, PhD, RAC, CCRP, Director of Clinical Affairs ) |
Study ID Numbers: | PMA 030022 |
Study First Received: | February 28, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00663351 |
Health Authority: | United States: Food and Drug Administration |
Arthritis Osteoarthritis Traumatic Arthritis Degenerative Joint Disease Avascular Necrosis |
Necrosis Musculoskeletal Diseases Osteonecrosis Osteoarthritis |
Arthritis Joint Diseases Rheumatic Diseases |