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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT04364295
Eligibility Criteria:
Inclusion Criteria:
* Have been treated with at least one SeaSpine product.
* Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.
* Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.
* Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.
Exclusion Criteria:
* Was not implanted with at least one SeaSpine product during operation
* Any other condition that the Investigator determines is unacceptable for enrollment into this registry
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04364295
Study Brief:
Protocol Section:
NCT04364295