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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by DePuy Orthopaedics
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01657435
First received: August 2, 2012
Last updated: August 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Non-inflammatory Degenerative Joint Disease (NIDJD)
Osteoarthritis
Avascular Necrosis
Post-traumatic Arthritis
Device: Ceramax Acetabular System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    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%.


Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Radiographic [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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.

  • Survivorship [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    At 5 years, the secondary outcome measure will include no components removed for any reason.


Estimated Enrollment: 250
Study Start Date: May 2012
Estimated Study Completion Date: January 2024
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ceramic-on-ceramic 28 mm Acetabular Cup

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657435

Contacts
Contact: Tammy L O'Dell, BS CCRC CCRA 574-372-7104 TODell2@its.jnj.com

Locations
United States, California
Recruiting
Sacramento, California, United States
United States, Colorado
Colorado Joint Replacement Recruiting
Denver, Colorado, United States, 80210
Withdrawn
Fort Collins, Colorado, United States
United States, Florida
Recruiting
Tampa, Florida, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Recruiting
Columbus, Ohio, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Not yet recruiting
Philadelphia, Pennsylvania, United States, 19148
United States, Virginia
Recruiting
Alexandria, Virginia, United States
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Tammy L ODell, BS CCRC CCRA DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01657435     History of Changes
Other Study ID Numbers: 09001
Study First Received: August 2, 2012
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DePuy Orthopaedics:
Total hip replacement
Total hip arthroplasty
Hip joint replacement
Hip prosthesis replacement

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014