Arthritis Trial Finder
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
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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
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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 |
Trial Details
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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 |
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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 |
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The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
DePuy Orthopaedics |
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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 |
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Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Canada, United States |
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The disease, disorder, syndrome, illness, or injury that is being studied. |
Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis |
Contact a Trial Team
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