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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01657435
Recruitment Status : Terminated (Adequate data to satisfy PAS as agreed to with FDA 02OCT2019)
First Posted : August 6, 2012
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief Summary:

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 or disease Intervention/treatment
Non-inflammatory Degenerative Joint Disease Osteoarthritis Avascular Necrosis Post-traumatic Arthritis 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.

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Study Type : Observational
Actual Enrollment : 185 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prothesis System
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : September 24, 2019
Actual Study Completion Date : September 24, 2019

Resource links provided by the National Library of Medicine


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 Name: Ceramic-on-ceramic 28 mm Acetabular Cup




Primary Outcome Measures :
  1. Survivorship [ Time Frame: 10 years ]
    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 :
  1. Harris Hip Score [ Time Frame: 5 years ]
    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.

  2. Radiographic [ Time Frame: 5 years ]

    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.

  3. Survivorship [ Time Frame: 5 years ]
    At 5 years, the secondary outcome measure will include no components removed for any reason.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657435


Locations
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United States, California
Joint Surgeons of Sacremento
Sacramento, California, United States
United States, Colorado
Colorado Joint Replacement
Denver, Colorado, United States, 80210
Fort Collins, Colorado, United States
United States, Florida
Florida University
Gainesville, Florida, United States
FOI Florida Orthopaedic Institute
Tampa, Florida, United States
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Tufts - New England Medical Center
Boston, Massachusetts, United States
United States, North Carolina
Duke University
Durham, North Carolina, United States
OrthoCarolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cardinal Orthopaedic Institute
Columbus, Ohio, United States
United States, Pennsylvania
UPenn
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States
Canada, Quebec
McGill University - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
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Study Director: Tammy L ODell, BS CCRC CCRA DePuy Orthopaedics
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Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01657435    
Other Study ID Numbers: 09001
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Keywords provided by DePuy Orthopaedics:
Total hip replacement
Total hip arthroplasty
Hip joint replacement
Hip prosthesis replacement
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Necrosis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes