This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.
This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase. The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of: 1. a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and 2. a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Hip replacement
Northside Hospital
Atlanta, Georgia, United States
Memorial Hospital
Springfield, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Fairview Hospital
Cleveland, Ohio, United States
Survivorship
Time frame: 5 years
Study subject SF-12 health survey
Time frame: 1, 2 ,3, 4 and 5 years
SF-12 Health survey and Subject Outcomes Questionnaire
Time frame: 6, 7, 8, 9 and 10 years
Hip Function (using Harris Hip Score)
Time frame: 6 weeks, 6 months and 1, 2, 3, 4, and 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Luke's Hospital
Maumee, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States