Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01657435
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.
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:
NCT01657435
Study Brief:
Protocol Section:
NCT01657435