28mm Ceramic-on-Ceramic Total Hip Replacement Study (COC28)

Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System

This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase.

In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.

In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Avascular Necrosis; Post-traumatic Arthritis; Non-inflammatory Degenerative Joint Disease
• Intervention / Treatment: Device: Ceramax Acetabular System

Detailed Description

This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This study will follow each subject through 10 years postoperatively and will consist of:

1. a clinical follow-up phase and
2. a clinical outcomes phase.

Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.

• Study Type: Observational
• Enrollment (Actual): 185

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • 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, 80210
      • Colorado Joint Replacement
    • Fort Collins, Colorado, United States
  • Florida
    • Gainesville, Florida, United States
      • Florida University
    • Tampa, Florida, United States
      • FOI Florida Orthopaedic Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital
    • Boston, Massachusetts, United States
      • TUFTS - New England Medical Center
  • North Carolina
    • Durham, North Carolina, United States
      • Duke University
    • Winston-Salem, North Carolina, United States
      • OrthoCarolina
  • Ohio
    • Columbus, Ohio, United States
      • Cardinal Orthopaedic Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • UPenn
  • Virginia
    • Alexandria, Virginia, United States
      • Anderson Orthopaedic Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males and females who are appropriate candidates for primary hip replacement o any age, with non-inflammatory degenerative joint disease or: males and females that had a primary hip replacement with CERAMAX as part of the 28 mm IDE study.

Description

Inclusion Criteria:

• Subjects who were previously enrolled in the COC28 IDE study, or
• Newly recruited individuals who are qualified based on the approved labeling of the device, and;
• 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 Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol

Exclusion Criteria:

• In the opinion of the Investigator, the individual does not qualify based upon approved labeling requirements.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Ceramax COC 28mm Acetabular Cup; The 28 mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. The Pinnacle acetabular shell is a hemispherical type acetabulum replacement prosthesis, is available in a range of outer diameter (OD) sizes, and is used with a 28mm femoral head. Pinnacle 100 shells will be used in this study. The BIOLOX® delta ceramic femoral head components are manufactured from the same ceramic material as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an interlocking taper.

Device: Ceramax Acetabular System; 28mm Ceramic-on-ceramic Acetabular Cup System; Other Names: Ceramic-on-ceramic 28 mm Acetabular Cup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	The primary outcome measure is that the 10-year Kaplan-Meier survivorship estimate of the COC 28mm implanted hips will be a minimum of 90% (as recommended by National Institute of Clinical Excellence [NICE]). Based on an anticipated margin of error (ie. one-half the width of the confidence interval) of 7%, the lower 95% confidence interval will be no worse than 83%.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score	At five years, the Harris Hip Score must be > 80 points or higher and the Harris Hip pain assessment must be mild or no pain.	5 years
Radiographic	At 5 years, secondary radiographic outcome measures will include: No radiolucencies >2mm in any zone in any post-operative interval;; No acetabular cup migration >4mm;; No change in cup inclination angle >4 degrees when compared to immediate post-operative angle; and; No osteolysis.	5 years
Survivorship	At 5 years, the secondary outcome measure will include no components removed for any reason.	5 years

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Tammy L ODell, BS CCRC CCRA, DePuy Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): September 24, 2019

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Total hip arthroplasty; Total hip replacement; Hip joint replacement; Hip prosthesis replacement
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Necrosis
• Other Study ID Numbers: 09001