R3 Delta Ceramic Acetabular System PAS U.S. (R3-PAS)
Status
Conditions
Treatments
Details and patient eligibility
About
R3 Delta Post-Approval Study U.S.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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