Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01657435
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01657435
Study Brief:
Protocol Section:
NCT01657435