R3® Acetabular System in Patients With Degenerative Hip Disease
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease|
- 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. [ Time Frame: 3 months, 1-5 years ] [ Designated as safety issue: Yes ]The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement.
- Adverse Events [ Time Frame: Post Operative - 5 years ] [ Designated as safety issue: Yes ]All perioperative and postoperative device-related and surgical adverse events will be recorded during this study.
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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.
|United States, Florida|
|Vero Beach, Florida, United States, 32960|
|Principal Investigator:||Richard McCalden, MD||London Health Science Centre-University Hospital London Ontario|
|Principal Investigator:||Colin Burnell, MD||Concordia Hospital, Winnipeg, Canada|
|Principal Investigator:||James Comadoll, MD||Ro Medical Orthopedics, Salisbury NC|
|Principal Investigator:||Richard Steinfeld, MD||Orthopaedic Center of Vero Beach, Vero Beach, FL|
|Principal Investigator:||Craig Della Valle, MD||Rush University Medical Center|
|Principal Investigator:||John Masonis, MD||OrthoCarolina Research Institute|
|Principal Investigator:||Ryan Nunley, MD||Washington University Orthopedics|
|Principal Investigator:||Michael Dunbar, MD||Halifax Infirmary|