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

NCT02096211 | Completed Results FDA Device

• 1 other identifier: 12017
• Study Type: interventional
• Target: 172
• Locations: 2 countries
• Sites: 13

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.

Conditions

Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Post-Traumatic Osteoarthritis of Hip

Keywords

Total hip replacement; Total hip arthroplasty; Hip joint replacement; Hip prosthesis replacement

Outcome Measures

Primary Outcomes (1)

• Post-Operative 5-Year Device Survivorship

  Device survivorship at 5 years post-operatively was the primary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A 5-year Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided.

  5 years

Secondary Outcomes (20)

• Kaplan Meier Device Survivorship at Years 1 Through 6

  Years 1 through 6 post-operatively

• Annual Total Harris Hip Score

  Annually through 5 years

• Annual Harris Hip Pain Sub Score

  Annually through 5 years

• Annual Harris Hip Function and Activity Score

  Annually through 5 years

• Acetabular Cup Version - Annual Measurements

  Measured from x-rays taken annually, years 1 through 5

Study Arms (1)

CERAMAX COC 36mm Acetabular Cup

OTHER

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

Interventions

COC 36mm DEVICE

Total Hip Replacement with COC 36mm Acetabular Cup System

Also known as: CERAMAX, CERAMAX 36mm, CERAMAX Acetabular System, 36mm CERAMAX Acetabular System

CERAMAX COC 36mm Acetabular Cup

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (13)

Joint Surgeons of Sacremento

Sacramento, California, United States

Location

Colorado Joint Replacement

Denver, Colorado, United States

Location

Florida Orthopaedic Institute

Tampa, Florida, United States

Location

Arthroplasty Foundation

Louisville, Kentucky, United States

Location

TUFTS - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Samuel Wellman, MD / Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Orthopedic One

Columbus, Ohio, 43213, United States

Location

UPenn

Philadelphia, Pennsylvania, 19104, United States

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Location

Queens University - Kingston General Hospital

Kingston, Quebec, Canada

Location

McGill University - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dave Whalen
• Organization: Johnson & Johnson MedTech

dwhalen@its.jnj.com

574-404-9399

Study Officials

• Terrence D Whalen, BS, DC

  DePuy Orthopaedics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: June 1, 2014
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 16, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-07

Locations

US (9); CA (4)