To demonstrate the safety and effectiveness of the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System in comparison to the Trinity™ Acetabular Hip System,which is FDA cleared for use in the U.S. The comparison will be based upon clinical success at the Month 24 endpoint.
The clinical research results for the Trinity™ BIOLOX delta™ Ceramic-on-Ceramic Total Hip System will be compared to the control device Clinical success is based upon Harris Hip Scores to evaluate functional status, adverse events, radiological assessments and no device failure (defined as removal, replacement, or modification of any device component).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
342
total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner
total hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner
Arkansas Specialty Orthopaedics
Little Rock, Arkansas, United States
Denver Hip and Knee, Inc.
Parker, Colorado, United States
Connecticut Joint Replacement Institute (CJRI)
Hartford, Connecticut, United States
Composite Clinical Success
* HHS ≥ 80 at Month 24 (good/excellent) * No serious, definitely device related complications with onset on or prior to Month 24 * No radiographic failure at Month 24 * No removal, replacement, or modification of any component on or prior to Month 24.
Time frame: 24 months post-operative
HHS
• Individual components of the Harris Hip Score (total score, pain and function).
Time frame: 24 months post-operative
HOOS score
Hip injury and Osteoarthritis Outcome Score (HOOS).
Time frame: 24 months
Subjective pain
VAS pain score
Time frame: 24 months
survival
Kaplan-Meier survival curve
Time frame: 24 months
adverse events
Summary of device-related complications
Time frame: 24 months
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Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Orthopaedic Institute
Tampa, Florida, United States
FMC Orthopedic Division
Tampa, Florida, United States
Resurgens Orthopaedics
Austell, Georgia, United States
OrthoCarolina Hip & Knee Center
Charlotte, North Carolina, United States
Memorial Bone & Joint
Houston, Texas, United States
Elective Orthopaedic Centre
Epsom, Surrey, United Kingdom