R3 Delta Ceramic Acetabular System PAS U.S.



Status:Recruiting
Conditions:Osteoarthritis (OA), Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:10/28/2018
Start Date:January 17, 2018
End Date:September 30, 2022
Contact:Darrell Lange
Email:Darrell.Lange@smith-nephew.com
Phone:817-302-3959

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Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US

R3 Delta Post-Approval Study U.S.

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic
Acetabular System is indicated for use in skeletally mature patients requiring primary total
hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as
osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the
study is a total of approximately 5 years: 6 months for site initiation, 12 months for
subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up
interval.

Inclusion Criteria:

- Patient is 18-75 years old and he/she is skeletally mature

- Patient requires primary total hip arthroplasty due to non-inflammatory degenerative
joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis,
or traumatic arthritis.

- 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

- Patient is willing and able to participate in required follow-up visits and to
complete study procedures and questionnaires

- Patient has consented to participating in the study by signing the IRB/EC approved
informed consent form

Exclusion Criteria:

- Patients with insufficient quantity or quality of bone support; metabolic bone
disease; osteoporosis

- Patients with neurological or muscular conditions that would place extreme load or
instability upon the hip joint

- Patients with active joint infections or chronic systemic infection

- Obese patients where obesity is defined as BMI > 40

- Skeletal immaturity

- Known allergy to implant materials
We found this trial at
10
sites
Charlotte, North Carolina 28207
Principal Investigator: John Masonis, MD
Phone: 980-960-2468
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Annapolis, Maryland 21401
Principal Investigator: James MacDonald, MD
Phone: 443-481-5757
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Annapolis, MD
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Austin, Texas 78750
Principal Investigator: Jacob Manuel, MD
Phone: 737-202-2500
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Austin, TX
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Baltimore, Maryland 21215
Principal Investigator: Ronald Delanois, MD
Phone: 410-601-9592
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Baltimore, MD
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Houston, Texas 77043
Principal Investigator: Stefan Kreuzer, MD
Phone: 346-571-7466
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Houston, TX
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Lexington, Kentucky 40508
Principal Investigator: Stephen Duncan, MD
Phone: 859-797-8197
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Lexington, KY
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Philadelphia, Pennsylvania 19104
Principal Investigator: Gwo-Chin Lee, MD
Phone: 215-294-9166
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Philadelphia, PA
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Reno, Nevada 89503
Principal Investigator: Jackson Jones, MD
Phone: 775-788-5190
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Reno, NV
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Tampa, Florida 33637
Principal Investigator: David Watson, MD
Phone: 813-978-9700
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Tampa, FL
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Tucker, Georgia 30084
Principal Investigator: Tom Bradbury, MD
Phone: 404-778-8051
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Tucker, GA
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