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.
