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

36mm CERAMAX® Ceramic Hip System PMA PAS STUDY: Short to Mid-Term Follow-up , New Study Subjects (Ceramic Hip System, Subjects Receive CERAMAX 36mm Ceramic Acetabular Bearing Insert That Articulates With a Ceramic Femoral Head for THA)

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Avascular Necrosis; Non-inflammatory Degenerative Joint Disease; Post-Traumatic Osteoarthritis of Hip
• Intervention / Treatment: Device: COC 36mm

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • QEII Health Sciences Centre
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre - University Hospital
  • Quebec
    • Kingston, Quebec, Canada
      • Queens University - Kingston General Hospital
    • Montreal, Quebec, Canada, H3T 1E2
      • McGill University - Jewish General Hospital
• United States
  • California
    • Sacramento, California, United States
      • Joint Surgeons of Sacremento
  • Colorado
    • Denver, Colorado, United States
      • Colorado Joint Replacement
  • Florida
    • Tampa, Florida, United States
      • Florida Orthopaedic Institute
  • Kentucky
    • Louisville, Kentucky, United States
      • Arthroplasty Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • TUFTS - New England Medical Center
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Samuel Wellman, MD / Duke University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Orthopedic One
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • UPenn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

One arm cohort, open label for Ceramax Ceramic on Ceramic hip system at various geographic US and Canadian orthopaedic clinics. 170 patients enrolled

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: CERAMAX; CERAMAX 36mm; CERAMAX Acetabular System; 36mm CERAMAX Acetabular System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaplan Meier Device Survivorship at Years 1 Through 6	Device survivorship at each year post-operative was a secondary 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 Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided for each post-operative year.	Years 1 through 6 post-operatively
Annual Total Harris Hip Score	The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent	Annually through 5 years
Annual Harris Hip Pain Sub Score	The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent This Secondary Outcome reports on the Pain Sub Score which has categories of None (44 points), Slight (40), Mild (30), Moderate (20), Marked (10), and Totally Disabled (0)	Annually through 5 years
Annual Harris Hip Function and Activity Score	The Harris Hip Score (HHS) is a standardized tool used to evaluate hip pain, function, and mobility. The HHS is score from 0 to 100, with higher scores indicating better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, 90-100 is excellent This Secondary Outcome reports on the Function and Activity Sub Score which has categories of Normal (40-47 points), Mild Dysfunction (30-39), Moderate Dysfunction (20-29), Severe Dysfunction (10-19), and Disabled (0 - 9)	Annually through 5 years
Acetabular Cup Version - Annual Measurements	Acetabular cup version is the angle formed between the axis of the implant and the coronal plane of the body. Acetabular version typically ranges between 11.5 and 28.5 degrees.	Measured from x-rays taken annually, years 1 through 5
Acetabular Cup Inclination	Acetabular cup inclination is the angle between the longitudinal axis of the patient and a perpendicular line to the major axis of the cup projection. The target acetabular cup inclination is between 30-50 degrees	Measured from x-rays taken annually, years 1 through 5
Acetabular Cup Migration	Acetabular migration is the superior migration of the implant within the pelvic bone	Measured from x-rays taken annually, years 1 through 5
Heterotopic Ossification	Heterotopic ossification is the abnormal formation of bone in soft tissues, such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class 0 being least impactful and Class IV being most impactful	Measured from x-rays taken annually, years 1 through 5
Acetabular Radiolucent Lines	Radiolucent lines are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack on bone ingrowth or possible loosening of the implant. Radiolucent lines greater than 1mm wide were considered reportable for this study.	Measured from x-rays taken annually, years 1 through 5
Acetabular Osteolysis	Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study.	Measured from x-rays taken annually, years 1 through 5
Acetabular Sclerotic Lines	Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.	Measured from x-rays taken annually, years 1 though 5
Femoral Stem Position	Femoral stem position is categorized as neutral, valgus, or varus. A neutral stem is centered within the femoral canal that runs through the center of the femur's long axis. A valgus femoral stem is positioned slightly towards the medial side of the femoral canal, and a varus femoral stem is positioned slightly towards the lateral side of the femoral canal.	Measured from x-rays taken annually, years 1 through 5
Femoral Stem Tilt	Femoral stem tilt is a measurement taken at each post-operative year and compared against baseline images collected at 6-weeks post-operative. The measurement captures changes in the position of the femoral stem over time. Tilt greater than 2 degrees was considered reportable for this study	Measured from x-rays taken annually, years 1 through 5
Femoral Stem Subsidence	Femoral stem subsidence is the inferior movement of the stem within the femoral canal. Subsidence greater than 2 mm was considered reportable for this study.	Measured from x-rays taken annually, years 1 through 5
Femoral Stem Heterotopic Ossification	Heterotopic ossification is the abnormal formation of bone in soft tissues such as muscles, tendons, or ligaments and can occur around the hip joint, leading to pain, stiffness, and restricted range of motion. It is graded as Class 0 through Class IV, with Class O having no bone growth in soft tissue, Class I being least impactful and Class IV being most impactful.	Measured from x-rays taken annually, years 1 through 5
Femoral Radiolucent Lines	Radiolucencies are seen on x-rays and represent an area that is absent of bone. Radiolucent lines seen adjacent to an implant may suggest a lack of bone ingrowth into the implant or possible loosening of the implant	Measured from x-rays taken annually, years 1 through 5
Femoral Osteolysis	Osteolysis is seen on x-rays and represent an area where bone has been resorbed by the body in response to small particles of debris that are created as an implant wears over time. Osteolysis greater than 5mm was considered to be reportable for this study.	Measured from x-rays taken annually, years 1 through 5
Femoral Stem Sclerotic Lines	Acetabular sclerotic lines are seen on x-rays and are radio-dense areas of bone that have remodeled due to loads close to the implant.	Measured from x-rays taken annually, years 1 through 5
Femoral Stem Calcar Resorption	Femoral calcar resorption occurs when the bone around the prosthesis is partially shielded from bearing loads and begins to resorb	Measure from x-rays taken annually, years 1 through 5
Femoral Stem Calcar Fracture	Near the top of the femur is a region of bone called the calcar femorale that provides strength to the femur when compressive forces are applied. During preparation of the femur to receive the femoral implant there is the possibility of fractures occurring in this region	Measured from x-rays taken annually, years 1 through 5

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Terrence D Whalen, BS, DC, DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimated): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 6, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Total hip replacement; Hip joint replacement; Hip prosthesis replacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Arthritis; Rheumatic Diseases; Joint Diseases; Necrosis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 12017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes