R3 Delta Ceramic Acetabular System PAS U.S.

Completed

Conditions studied: Degenerative Joint Disease

In brief

R3 Delta Post-Approval Study U.S.

Key facts

Study ID: NCT03056534
Run by: Smith & Nephew, Inc.
People needed: 189
Starts: 2018-02-07
Expected to finish: 2023-05-31
Last updated by the study team: 2025-04-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Foundation for Orthopaedic Research and Education — Tampa, Florida, United States
Emory University — Tucker, Georgia, United States
Luminis Health — Annapolis, Maryland, United States
Rubin Institute for Advanced Orthopedics, Sinai Hospital — Baltimore, Maryland, United States
Reno Orthopaedic Clinic Foundation — Reno, Nevada, United States
University of Pennsylvania, Department of Orthopaedic Surgery — Philadelphia, Pennsylvania, United States
St. David's Center for Hip and Knee Replacement — Austin, Texas, United States
INOV8 Healthcare — Houston, Texas, United States

Full record on ClinicalTrials.gov

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