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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT04888104
Eligibility Criteria:
Inclusion Criteria:
1. \>18 years of age at the time of treatment
2. EOS full body or standing 36" AP \& Lateral images of entire spine
3. Posterior spine fusion with pedicle screw fixation construct of 5 or more levels
4. Pedicle screw fixation to be supplemented proximally with NuVasive VersaTie system
5. Upper instrumented vertebra (UIV) terminating at a newly instrumented level
6. Lowest instrumented vertebra (LIV) sacrum/pelvis
7. Surgery scheduled to take place in the next 6 months
Exclusion Criteria:
1. Active spine tumor or infection
2. Deformity due to acute trauma
3. Prisoners
4. Women who are pregnant
5. Patient is unwilling or unable to complete questionnaires
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04888104
Study Brief:
Protocol Section:
NCT04888104