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

NCT ID: NCT02096211

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2023-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

COC 36mm

Intervention Type: DEVICE

Total Hip Replacement with COC 36mm Acetabular Cup System

Interventions

COC 36mm

Total Hip Replacement with COC 36mm Acetabular Cup System

Intervention Type: DEVICE

Other Intervention Names

CERAMAX; CERAMAX 36mm; CERAMAX Acetabular System; 36mm CERAMAX Acetabular System

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terrence D Whalen, BS, DC

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

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

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

12017

Identifier Type: -

Identifier Source: org_study_id