Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)

Conditions
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Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance

Intervention / Treatment
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* Procedure: Index or spine revision surgery for complex adult spinal deformity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. >18 years of age at the time of treatment 2. Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity 3. EOS full body or standing 36 AP & Lateral images of entire spine 4. Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected) 5. Surgery to include > 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone lateral 6. And any one of the following: a. Radiographic criteria incorporating percutaneous posterior spinal instrumentation: i. PI-LL ≥ 25 degrees ii. Thoracolumbar/lumbar scoliosis ≥ 20 degrees iii. SVA >10cm iv. PT > 30 b. Procedural criteria: i. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 &/or pelvis/ilium is not) ii. Staged ≥ 3 levels fused with percutaneous pedicle screws iii. 3 column osteotomy with percutaneous fixation iv. ACR incorporating open or percutaneous fixation Exclusion Criteria: Deformity due to acute trauma Active spine tumor or infection Patient is unwilling or unable to complete questionnaires Women who are pregnant Prisoners -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operative<br>Multicenter, prospective, nonrandomized analysis of ASD patients w/diagnosis of congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity. Participants must be scheduled to have 3 or more levels of Percutaneous posterior spinal instrumentation or 3 level stand alone lateral surgery within next 6 months. | Procedure: Index or spine revision surgery for complex adult spinal deformity<br>* Surgical interventions will be patient specified by treating surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoliosis Research Society (SRS) 22r | Scoliosis specific patient reported outcome | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Oswestry Disability Index (ODI) | Spine specific patient reported outcome | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 
| Radiographic Evaluation | Cobb angles, Coronal & Sagittal balance, spinopelvic measures | 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) | 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) | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edmonton Frail Scale | Evaluate frailty on scale of 0 to 17 where higher scores mean more frail | 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 | 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 | Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scoliosis, Kyphosis, Sagittal Imbalance, Spinal Deformity