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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01343693
Eligibility Criteria:
Inclusion Criteria:
* Subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System.
* Subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits.
* Subjects or their representative must be willing and able to give informed consent.
Exclusion Criteria:
* Subject has spinal infection or inflammation at any level.
* Subject is morbidly obese, defined as a BMI greater than 40.
* Subject has a mental illness, alcoholism or drug abuse.
* Subject has a metal sensitivity/foreign body sensitivity.
* Subject has inadequate tissue coverage over the operative site.
* Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis.
* Female subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating.
* Subject who does not meet the specific indications for use of the MaxAn® Anterior Cervical Plate System.
* Subjects participating in another clinical research study.
* Any previous cervical spinal surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01343693
Study Brief:
Protocol Section:
NCT01343693