Study of the VersaTie System to Prevent Complications in Adult Long Posterior Spinal Fusion Surgery

What this Trial Is About

Researchers are evaluating the safety and performance of long posterior spinal fusion surgeries in adults with complex spinal deformities such as scoliosis and kyphosis. This study compares spinal fusion constructs that use the VersaTie Posterior Fixation System with those that do not, aiming to prevent complications like proximal junctional failure. It also seeks to develop guidelines for surgical treatment and assess factors like blood management, opioid use, mental and social health, and patient frailty. The study observes adult patients undergoing spine surgery involving at least five vertebrae fused with pedicle screw fixation, where the proximal part of the fixation may be supplemented with the VersaTie System. Imaging of the full spine is required before surgery. Researchers will evaluate clinical and radiographic outcomes, complications, patient-reported outcomes using various tools including PROMIS and legacy measures, and will follow patients for up to 10 years after surgery. Participants will be monitored through scheduled assessments at 3 months and 1, 2, 5, and 10 years after surgery. These evaluations include physical function tests, frailty scales, quality of life questionnaires, pain scales, and adverse event tracking. The study also explores the impact of prehabilitation and mental health on surgical outcomes, aiming to improve treatment approaches and establish best practices for adult spinal deformity surgery.

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