Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.
Specific Aims: * Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications. a. Complex ASD patients will be defined based upon clinical, radiographic and/or procedural criteria. * Develop and validate a standardized, universal complications classification system for minimally invasive spine surgery * Evaluate perioperative blood management approaches, transfusion requirements, including variance in thresholds for blood transfusion and associated complications for minimally invasive adult spinal deformity surgery * Evaluate clinical outcomes utilizing legacy patient reported outcome measures (PROMs) including Scoliosis Research Society 22r (SRS 22r) modified Oswestry Disability Index (mODI), Veterans RAND-12 (VR-12), and numeric pain rating scale (NRS), and patient reported outcome measurement information system (PROMIS). * Evaluate clinical outcomes stratifying by patient chronological and physiological age * Evaluate the cost for episode of care for minimally invasive CADS surgery and cost per QALY gain compared to open surgery for CADS * Evaluate the contribution of patient frailty to patient outcomes, cost of care, disability, and complications * Evaluate incidence of and risk factors for mental health (MH) compromise among ASD patients treated with MIS techniques, and establish best practice guidelines for assessing MH * Evaluate the association of MH with surgical complications, outcomes, hospital length of stay and cost for MIS ASD surgery * Evaluate the association of social health surgical complications, outcomes, hospital length of stay and cost for MIS ASD surgery and risk factors for routine (home) discharge vs. skilled nursing facility (SNF)/rehabilitation facility * Broaden the evaluation of the minimally invasive 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 minimally invasive surgical treatment of ASD * Evaluate the use of robotic techniques in minimally invasive spine surgery for ASD, and its impact on radiographic parameters and clinical outcomes * Evaluate the use of expandable cages in minimally invasive spine surgery for ASD, and its impact on radiographic parameters and clinical outcomes * Evaluate the OR efficiency, morbidity of surgery, and cost per episode of care relating to single-position vs. multi-position CADS surgery * Evaluate the prevalence and incidence of sacroiliac pain before/after complex adult spinal deformity surgery.
Study Type
OBSERVATIONAL
Enrollment
500
Surgical interventions will be patient specified by treating surgeon.
Barrow Neurological Institute
Phoenix, Arizona, United States
RECRUITINGShiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California - San Francisco Medical Center
San Francisco, California, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGRush University, Department of Neurosurgery
Chicago, Illinois, United States
RECRUITINGLouisiana Spine Institute
Shreveport, Louisiana, United States
RECRUITINGUniversity of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, United States
COMPLETEDColumbia University - New York-Presbyterian Och Spine Hospital
New York, New York, United States
RECRUITINGDuke University Health System
Durham, North Carolina, United States
RECRUITING...and 2 more locations
Scoliosis Research Society (SRS) 22r
Scoliosis specific patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Oswestry Disability Index (ODI)
Spine specific patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Veterans RAND 12 Item Health Survey (VR-12)
Patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Computer adaptive Patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Computer adaptive Patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Computer adaptive Patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
Computer adaptive Patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction
Computer adaptive Patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction
Computer adaptive Patient reported outcome
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Radiographic Evaluation
Cobb angles, Coronal \& Sagittal balance, spinopelvic measures
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Visual Analog Scale - Back Pain
Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Visual Analog Scale - Leg pain
Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Edmonton Frail Scale
Evaluate frailty on scale of 0 to 17 where higher scores mean more frail
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Canadian Study of Health and Aging (CSHA)
Frailty scale of 1 to 9; higher scores mean more frail
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Adverse Events
Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study
Time frame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
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