Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Up to 10 (up to 5 original IDE + 5 new sites)
A prospective, non-controlled, non-randomized, multicenter study. Subjects will be seen for a clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3 years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2555 days).
Data collected will include: Pre-operatively subject history and demographics; Operative and device details; and Post-operatively Harris HIp scores, Subject Hip Outcomes, and Adverse Events.
In order to optimize mid-term follow-up compliance, site personnel are permitted to contact the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to assess the current status of the hip.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CERAMAX COC 36mm Acetabular Cup The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. |
Device: COC 36mm
Total Hip Replacement with COC 36mm Acetabular Cup System
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Device Survivorship at 5-years post-operatively [5 years post-operatively]
Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 5 years post-operatively.
Secondary Outcome Measures
- Device Survivorship [1-year, 2-years, 3-years, and 4-years]
Device survivorship will be estimated at each year post-operatively using the Kaplan-Meier Survivorship Analysis
- Harris Hip Scores [Harris Hip Score means and Harris Hip Sub-score means will be estimated at 6-Wks (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825-2555 days)]
The Harris Hip score consists of five subscales: Pain, Function, Activities, Deformity and Range of motion. This validated outcomes instrument is designed for completion by a clinician.
- Subject Hip Outcomes (Clinic) [Subject Hip Outcomes will be estimated at 6-Wks (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825- 2555 days)]
Subject Hip Outcomes (Clinic) will be estimated at each year post-operatively. Subject Hip Outcomes is a standardized instrument for use as a measure of health outcome that is designed for completion by the study subject. This hips outcomes self-assessment includes five (5) questions about subject satisfaction and hip function. The 5 questions subject's will answer regard their function, pain, need for pain meds, satisfaction and status (i.e., better, same, worse). The percent of subjects who answer 'Yes' or 'Better' on each respective question will be reported.
- Radiographs [6-Weeks, (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825- 2555 days)]
High quality antero-posterior and lateral radiographs of the operative hip will be obtained during the same intervals as for the clinical evaluations. At the first post-operative visit (6-Weeks), an additional Cross-Table Lateral film will be collected to permit assessment of the cup positioning. Radiographic views: AP AP femur view is required only when the distal end of the femur is not visible on the AP-Pelvis view) Lateral Cross-Table Lateral (Only at 6-Week post-op) As a single composite radiographic outcome, the percent of subjects with radiolucencies greater than 2 mm, acetabular cup migration greater than 4 mm, change in cup inclination greater than 4 degrees or osteolysis at the time of last radiographic assessment will be reported.
- Adverse Events [6-Wks (1-92 days); 1-year (275-455 days); 2-years (640-820 days); 3-years (1005-1185 days); 4-years (1370-1550 days); Minimum 5-years (1825- 2555 days)]
Adverse Events must be reported for all Subjects and will be reported by category (intraoperative, postoperative-operative site, systemic, and overall) at all study visit intervals.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females between 21 - 75 at the time of surgery.
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Individuals, who in the opinion of the investigator, are suitable candidates for primary total hip replacement using the devices specified in this protocol.
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Individuals with non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic arthritis.
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Individuals who are willing and able to provide informed patient consent for participation in the study;
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Individuals who are willing and able to return for follow-up as specified by the study protocol; and
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Individuals who are willing and able to complete the Subject Hip Outcomes questionnaire as specified by the study protocol.
Exclusion Criteria:
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Skeletally immature patients (tibial and femoral epiphyses not closed)
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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.)
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The presence of any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) disease
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Significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis)
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Presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
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Any condition that may interfere with postoperative recovery (e.g., Paget's disease, Charcot's disease)
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Inadequate bone stock to support the device (e.g., severe osteopenia orosteoporosis)
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Poor skin coverage around the hip joint
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Use in patients with known allergies to the implant materials
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Marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a birth defect affecting the leg bones.
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Inflammatory degenerative joint disease (like rheumatoid arthritis)
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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.
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Subject is currently involved in a personal injury litigation, medical-legal or worker's compensation claims.
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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.
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The Subject is a woman who is pregnant or lactating.
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The Subject has a medical condition with less than 2 years of life expectancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Joint Surgeons of Sacremento | Sacramento | California | United States | |
| 2 | Colorado Joint Replacement | Denver | Colorado | United States | |
| 3 | Florida Orthopaedic Institute | Tampa | Florida | United States | |
| 4 | Arthroplasty Foundation | Louisville | Kentucky | United States | |
| 5 | TUFTS - New England Medical Center | Boston | Massachusetts | United States | 02111 |
| 6 | New England Baptist Hospital | Boston | Massachusetts | United States | 02120 |
| 7 | Samuel Wellman, MD / Duke University Medical Center | Durham | North Carolina | United States | 27705 |
| 8 | Orthopedic One | Columbus | Ohio | United States | 43213 |
| 9 | UPenn | Philadelphia | Pennsylvania | United States | 19104 |
| 10 | QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | |
| 11 | London Health Sciences Centre - University Hospital | London | Ontario | Canada | |
| 12 | Queens University - Kingston General Hospital | Kingston | Quebec | Canada | |
| 13 | McGill University - Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
Sponsors and Collaborators
- DePuy Orthopaedics
Investigators
- Study Director: Tammy L ODell, BS, DePuy Orthopaedics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12017