R3® Acetabular System in Patients With Degenerative Hip Disease

Completed

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT01407029

Run by

Smith & Nephew, Inc.

People needed

158

Starts

2009-10-01

Expected to finish

2017-03-14

Last updated by the study team

2017-04-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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