Status:
COMPLETED
R3® Acetabular System in Patients With Degenerative Hip Disease
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-75 years
Brief Summary
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.
Detailed Description
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¬-ran...
Eligibility Criteria
Inclusion
- Patient is of legal age to consent and skeletally mature.
- Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, and dysplasia/DDH)
- Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk.
- The patient will be available for follow-up throughout the duration of the study.
Exclusion
- Patient has active infection or sepsis (treated or untreated)
- Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
- Patient is pregnant or plans to become pregnant during the course of the study Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- Patient has inflammatory joint disease (e.g. rheumatoid arthritis)
- Patient has known moderate to severe renal insufficiency.
- Patient has a known or suspected metal sensitivity.
- Patient is immunosuppressed or receiving high doses of corticosteroids.
- Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
- Patient has BMI \>40.
- Patient is a prisoner
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 14 2017
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01407029
Start Date
October 1 2009
End Date
March 14 2017
Last Update
April 25 2017
Active Locations (8)
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1
Orthopedic Center of Vero Beach
Vero Beach, Florida, United States, 32960
2
Midwest Orthopedics at Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Washington University Orthopedics
St Louis, Missouri, United States, 63110
4
Ortho Carolina
Charlotte, North Carolina, United States, 28207