Study Results
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Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2018-07-30
2032-07-31
Brief Summary
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Detailed Description
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• 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 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 identified in an analysis of the existing ISSG ASD database: i. Magnitude of coronal and/or sagittal spinal deformity ≥75th percentile of patients in the ISSG database.
ii. Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery and/or patients that had hospital length of stay \>9 days.
iii. Procedures involving 3 column osteotomies and/or anterior column reconstruction (ACR) of the spine
* 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
1. Validation of the PROMIS tool for ASD
2. Establish a core set of PROMs for best practice guidelines for ASD
3. 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
4. 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, 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Operative
A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria
1. 18 years of age or greater at the time of treatment
2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
3. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
4. Complex patients are defined as and meeting any one of the subsequent criteria:
a. Radiographic criteria: i. PI-LL ≥ 25 degrees ii. TPA ≥ 30 degrees iii. SVA\>15cm iv. Thoracic scoliosis ≥ 70 degrees v. Thoracolumbar/lumbar scoliosis ≥ 50 degrees vi. Global coronal malalignment \>7cm b. Procedural criteria: i. Posterior spinal fusion \> 12 levels ii. 3 column osteotomy or ACR c. Geriatric criteria: i. Age \>65 years and minimum 7 levels of spinal instrumentation during surgery
Index or spine revision surgery for complex adult spinal deformity
Surgical interventions will be patient specified by treating surgeon.
Interventions
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Index or spine revision surgery for complex adult spinal deformity
Surgical interventions will be patient specified by treating surgeon.
Eligibility Criteria
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Inclusion Criteria
2. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
3. Complex patients are defined as and meeting any one of the subsequent criteria:
1. Radiographic criteria:
* PI-LL ≥ 25 degrees
* TPA ≥ 30 degrees
* SVA\>15cm
* Thoracic scoliosis ≥ 70 degrees
* Thoracolumbar/lumbar scoliosis ≥ 50 degrees
* Global coronal malalignment \>7cm
2. Procedural criteria:
* Posterior spinal fusion \> 12 levels
* 3 column osteotomy or ACR
3. Geriatric criteria:
* Age \>65 years and minimum 7 levels of spinal instrumentation during surgery
Exclusion Criteria
2. Active spine tumor or infection
3. Deformity due to acute trauma
4. Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
5. Syndromic scoliosis
6. Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
7. Prisoners
8. Women who are pregnant
9. Non English speaking patients
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Globus Medical Inc
INDUSTRY
SI-BONE, Inc.
INDUSTRY
International Spine Study Group Foundation
OTHER
Responsible Party
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Principal Investigators
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Shay Bess, MD
Role: PRINCIPAL_INVESTIGATOR
Denver International Spine Center
Lawrence Lenke, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University, Department of Orthopedic Surgery
Christopher Shaffrey, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University, Departments of Neurosurgery and Orthopaedic Surgery
Locations
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Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States
University of California, Davis, Department of Orthopedic Surgery
Sacramento, California, United States
UCSF, Department of Neurosurgery
San Francisco, California, United States
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, United States
University of Kansas, Department of Orthopedic Surgery
Kansas City, Kansas, United States
Norton Leatherman Spine Center
Louisville, Kentucky, United States
Spine Institute of Louisiana
Shreveport, Louisiana, United States
John Hopkins University, Department of Orthopedic Surgery
Baltimore, Maryland, United States
Washington University, Department of Orthopedic Surgery
St Louis, Missouri, United States
NYU, Department of Orthopedics
New York, New York, United States
Hospital for Special Surgery, Department of Orthopedic Surgery
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Northwell Health
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
University Orthopedics
Providence, Rhode Island, United States
Medical City Spine Hospital - Southwest Scoliosis Institute
Dallas, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Toronto Western
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Passias PG, Tretiakov P, Onafowokan OO, Das A, Lafage R, Smith JS, Line BG, Nayak P, Diebo B, Daniels AH, Gum JL, Hamilton DK, Buell TJ, Soroceanu A, Scheer JK, Eastlack RK, Mullin JP, Schoenfeld AJ, Mundis GM, Hosogane N, Yagi M, Mummaneni PV, Chou D, Fu KM, Than KD, Anand N, Okonkwo DO, Wang MY, Klineberg E, Kebaish KM, Lewis S, Hostin R, Gupta M, Lenke L, Kim HJ, Ames CP, Shaffrey CI, Bess S, Schwab F, Lafage V, Burton D. When is staging complex adult spinal deformity advantageous? Identifying subsets of patients who benefit from staged interventions. J Neurosurg Spine. 2024 Nov 22;42(2):185-192. doi: 10.3171/2024.8.SPINE24365. Print 2025 Feb 1.
Other Identifiers
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2123
Identifier Type: -
Identifier Source: org_study_id
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