Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)

Completed · Not applicable

Conditions studied: Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip

In brief

This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.

Key facts

Study ID

NCT02096211

Run by

DePuy Orthopaedics

People needed

172

Starts

2014-06-01

Expected to finish

2023-12-31

Last updated by the study team

2025-07-16

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females between 21 - 75 at the time of surgery.
• Individuals, who in the opinion of the investigator, are suitable candidates for primary total hip replacement using the devices specified in this protocol.
• Individuals with non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic arthritis.
• Individuals who are willing and able to provide informed patient consent for participation in the study;
• Individuals who are willing and able to return for follow-up as specified by the study protocol; and
• Individuals who are willing and able to complete the Subject Hip Outcomes questionnaire as specified by the study protocol.

You may not qualify if…

• Skeletally immature patients (tibial and femoral epiphyses not closed)
• Evidence of active infections that may spread to other areas of the body (e.g.,osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.)
• The presence of any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) disease
• Significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis)
• Presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
• Any condition that may interfere with postoperative recovery (e.g., Paget's disease, Charcot's disease)
• Inadequate bone stock to support the device (e.g., severe osteopenia orosteoporosis)
• Poor skin coverage around the hip joint
• Use in patients with known allergies to the implant materials
• Marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a birth defect affecting the leg bones.
• Inflammatory degenerative joint disease (like rheumatoid arthritis)
• Subject has participated in an IDE/IND clinical investigation, other than the COC28/COC36 IDE or PAS for their contralateral hip, with an investigational product in the last three months.
• Subject is currently involved in a personal injury litigation, medical-legal or worker's compensation claims.
• Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to comply with protocol procedures and/or subject-completed questionnaires.
• The Subject is a woman who is pregnant or lactating.
• The Subject has a medical condition with less than 2 years of life expectancy.

Where it is running

• Joint Surgeons of Sacremento — Sacramento, California, United States
• Colorado Joint Replacement — Denver, Colorado, United States
• Florida Orthopaedic Institute — Tampa, Florida, United States
• Arthroplasty Foundation — Louisville, Kentucky, United States
• TUFTS - New England Medical Center — Boston, Massachusetts, United States
• New England Baptist Hospital — Boston, Massachusetts, United States
• Samuel Wellman, MD / Duke University Medical Center — Durham, North Carolina, United States
• Orthopedic One — Columbus, Ohio, United States
• UPenn — Philadelphia, Pennsylvania, United States
• QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
• London Health Sciences Centre - University Hospital — London, Ontario, Canada
• Queens University - Kingston General Hospital — Kingston, Quebec, Canada
• McGill University - Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.