Trinity Elite

Study added: 18 Apr 2018

Contact

Christiana Booher

434-243-0296

clb6xx@hscmail.mcc.virginia.edu

Subject must be 18 years of age (≥ 18 years) or older at the time of consent.
Subject must be a candidate for lumbar fusion study. The approach is at the physician’s discretion
Subject must require lumbar posterolateral arthrodesis at 1-4 contiguous levels (L1-S1) for a PLF approach and 1-2 contiguous levels for an interbody approach
Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery.
Subject must be willing and able to sign an informed consent document.
Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.

Subject is under 18 years of age (<18) at the time of consent.
Subject has had prior lumbar spine fusion at the level currently scheduled for surgery.
Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy within the past 5 years (benign skin cancer permitted).
Subject is pregnant or nursing or planning to become pregnant during the 2 years (24 months) following arthrodesis.
Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.
Subject has an allergy to DMSO.
Subject has any other condition that in the opinion of the Investigator would prohibit the subject from complying with the study protocol.
Subject is a prisoner.

Total: $300