NCT04888104 Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients
| NCT ID | NCT04888104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Spine Study Group Foundation |
| Condition | Adult Spinal Deformity |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2021-07-09 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2021-07-09 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients
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
Contact & Investigator
Shay Bess, MD
PRINCIPAL INVESTIGATOR
Presbyterian/St Luke's Medical Center
Frequently Asked Questions
Who can join the NCT04888104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adult Spinal Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04888104 currently recruiting?
Yes, NCT04888104 is actively recruiting participants. Contact the research team at baldusc@wustl.edu for enrollment information.
Where is the NCT04888104 trial being conducted?
This trial is being conducted at Phoenix, United States, La Jolla, United States, San Francisco, United States, Denver, United States and 5 additional locations.
Who is sponsoring the NCT04888104 clinical trial?
NCT04888104 is sponsored by International Spine Study Group Foundation. The principal investigator is Shay Bess, MD at Presbyterian/St Luke's Medical Center. The trial plans to enroll 225 participants.