Evaluate the safety and performance of posterior spinal fusion constructs supplemented
with posterior spinolaminar fixation using the VersaTie System compared to posterior
fixation constructs without VersaTie System supplementation in adult patients undergoing
long posterior spinal fusion by evaluating intraoperative and postoperative
complications, clinical and radiographic outcomes, patient-reported outcomes (PROs) and
need for revision surgery.
Evaluate surgical treatment outcomes and identify best practice guidelines for complex
adult spinal deformity (ASD) patients, including radiographic and clinical outcomes,
surgical and postoperative complications, risk factors for and revision surgery.
Develop and validate a standardized, universal complications classification system for
spine surgery
Evaluate perioperative blood management approaches, transfusion requirements, including
variance in thresholds for blood transfusion and associated complications for adult
spinal deformity surgery
Assess impact of opioid use and pain management on patient cost, complications and
outcomes
Evaluate optimal opioid and analgesic usage and protocols for standard work development
Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs)
including modified Oswestry Disability Index (mODI), Scoliosis Research Society
Questionnaire 22r (SRS-22r), Veterans RAND-12 (VR-12), and numeric pain rating scale
(NRS) and compare the results of these legacy PROMs to outcomes scores as measured by
the NIH Patient Reported Outcomes Measurement Information System (PROMIS) - PROMIS
Anxiety, Depression, Pain Interference, Physical Function, and Social Satisfaction.
Secondary aims for PROM research for this study include
Validation of the PROMIS tool for ASD
Establish a core set of PROMs for best practice guidelines for ASD
Evaluate patient reported outcome variance for ASD according to SRS-Schwab spine
deformity type including variance in baseline PROM domains impacted and variance in
improvement in PROM domains
Evaluate ASD outcomes compared to population norms and investigate/develop
appropriate measures of clinically significant improvement
Evaluate clinical outcomes stratifying by patient chronological and physiological age
Evaluate measures to quantify patient physiological age including patient frailty for
ASD and validate a frailty measurement system for ASD
Evaluate the role of functional tests in patient's baseline frailty assessment including
hand manometer and Edmonton Frail Scale. See appendix, pages 17 & 18 for details.
Evaluate the contribution of patient frailty to patient outcomes, complications, cost of
care, disability, and complications
Evaluate if patient frailty is a static measure or if frailty is a dynamic measure that
can be improved through "pre-habilitation" and if the according associations with
reductions in frailty correlate with reductions of cost, complications, and improvement
in outcomes
Evaluate cost variance for ASD surgery according to patient, institution, and
geographical region and evaluate the cost effectiveness of surgical intervention for ASD
Evaluate incidence of and risk factors for mental health (MH) compromise among ASD
patients and establish best practice guidelines for assessing MH for ASD patients
Evaluate the association of MH with surgical complications, outcomes, hospital length of
stay and cost for ASD surgery
Evaluate the association of social health surgical complications, outcomes, hospital
length of stay and cost for ASD surgery and risk factors for routine (home) discharge
vs. skilled nursing facility (SNF)/rehabilitation facility
Broaden the evaluation of the surgically treated ASD patient to maximize evaluation of
the entirety of the episode of care to include steps that can be taken prior to surgery
including "prehabilitation," pain management, and MH care to improve treatment outcomes,
reduce cost, reduce hospital length of stay, reduce non-routing discharge and reduce
early and late complications
Establish a core set of standard work guidelines to clinically and radiographically
evaluate and treat ASD patients and evaluate the utility of standard work to improve
outcomes for ASD and formulate best practice guidelines for surgical treatment of ASD
Develop predictive analytic algorithms to risk stratify for best/worst outcomes,
complications, sentinel events, and economic loss for ASD surgery
Evaluate the prevalence and incidence of sacroiliac pain before/after complex adult
spinal deformity surgery.