This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System.
The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years.
Study Type
OBSERVATIONAL
Enrollment
158
Orthopedic Center of Vero Beach
Vero Beach, Florida, United States
Midwest Orthopedics at Rush University Medical Center
Chicago, Illinois, United States
Washington University Orthopedics
St Louis, Missouri, United States
Ortho Carolina
Charlotte, North Carolina, United States
Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes.
The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement.
Time frame: 3 months, 1-5 years
Adverse Events
All perioperative and postoperative device-related and surgical adverse events will be recorded during this study.
Time frame: Post Operative - 5 years
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Novant Health Pinnacle Orthopedics
Salisbury, North Carolina, United States
Concordia Hip and Knee Institute
Winnipeg, Manitoba, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
London Health Science Center
London, Ontario, Canada