28mm Ceramic-on-Ceramic Total Hip Replacement Study

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01657435
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	DePuy Orthopaedics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tammy L ODell, BS CCRC CCRA
Principal Investigator Affiliation	DePuy Orthopaedics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis

Additional Details

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.

Arms & Interventions

Arms

Other: 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.

Interventions

Device: - Ceramax Acetabular System

28mm Ceramic-on-ceramic Acetabular Cup System

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Joint Surgeons of Sacremento, Sacramento, California

Status

Completed

Address

Joint Surgeons of Sacremento

Sacramento, California,

Site Contact

TODell2@its.jnj.com

574-372-7104

Colorado Joint Replacement, Denver, Colorado

Status

Completed