N/A
N=170
Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)
Non-inflammatory Degenerative Joint Disease · Osteoarthritis · Avascular Necrosis · Post-Traumatic Osteoarthritis of Hip
Bottom Line
View on ClinicalTrials.gov: NCT02096211 ↗Enrolled (actual)
170
Serious AEs
50.6%
Results posted
May 2025
Primary outcome: Primary: Post-Operative 5-Year Device Survivorship — 95.3 Percentage of implants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- COC 36mm (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- DePuy Orthopaedics
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-Operative 5-Year Device Survivorship |
95.3 | — |
| SECONDARY Kaplan Meier Device Survivorship at Years 1 Through 6 |
97.7; 96.5; 95.9; 95.3; 95.3; 95.3 | — |
| SECONDARY Annual Total Harris Hip Score |
98; 18; 4; 8; 90; 20 | — |
| SECONDARY Annual Harris Hip Pain Sub Score |
84; 28; 7; 6; 2; 1 | — |
| SECONDARY Annual Harris Hip Function and Activity Score |
96; 28; 3; 1; 0; 99 | — |
| SECONDARY Acetabular Cup Version - Annual Measurements |
22.8; 23.7; 25.1; 23.8; 26.1 | — |
| SECONDARY Acetabular Cup Inclination |
42.9; 42.2; 42.6; 43; 43.5 | — |
| SECONDARY Acetabular Cup Migration |
0; 0; 0; 0; 0 | — |
| SECONDARY Heterotopic Ossification |
87; 15; 21; 3; 0; 1 | — |
| SECONDARY Acetabular Radiolucent Lines |
1; 1; 1; 1; 1 | — |
| SECONDARY Acetabular Osteolysis |
2; 2; 0; 0; 1 | — |
| SECONDARY Acetabular Sclerotic Lines |
1; 3; 3; 3; 3 | — |
| SECONDARY Femoral Stem Position |
79; 10; 35; 2; 1; 77 | — |
| SECONDARY Femoral Stem Tilt |
3; 3; 3; 2; 5 | — |
| SECONDARY Femoral Stem Subsidence |
0; 0; 0; 0; 0 | — |
| SECONDARY Femoral Stem Heterotopic Ossification |
87; 21; 14; 3; 0; 2 | — |
| SECONDARY Femoral Radiolucent Lines |
0; 1; 0; 0; 0 | — |
| SECONDARY Femoral Osteolysis |
0; 0; 0; 0; 0 | — |
| SECONDARY Femoral Stem Sclerotic Lines |
1; 5; 5; 1; 7 | — |
| SECONDARY Femoral Stem Calcar Resorption |
1; 2; 2; 2; 3 | — |
| SECONDARY Femoral Stem Calcar Fracture |
0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02096211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.