Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Christopher Ames, MD

Description

Summary

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.

Official Title

Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Details

Specific Aims:

• 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.

  1. 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
  • 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, 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

Keywords

Adult Spinal Deformity Scoliosis Kyphosis Sagittal Imbalance Saggittal Imbalance Spinal deformity Congenital Abnormalities Index or spine revision surgery for complex adult spinal deformity Operative

Eligibility

For people ages 18 years and up

Criteria:

Inclusion Criteria:

  1. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
  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:
  4. Radiographic criteria:
  5. PI-LL ≥ 25 degrees
  6. TPA ≥ 30 degrees
  7. SVA>15cm
  8. Thoracic scoliosis ≥ 70 degrees
  9. Thoracolumbar/lumbar scoliosis ≥ 50 degrees
  10. Global coronal malalignment >7cm
  11. Procedural criteria:
  12. Posterior spinal fusion > 12 levels
  13. 3 column osteotomy or ACR
  14. Geriatric criteria:
  15. Age >65 years and minimum 7 levels of spinal instrumentation during surgery

Exclusion Criteria:

  1. Age <18 years of age
  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

Locations

  • UCSF, Department of Neurosurgery not yet accepting patients
    San Francisco California 94143 United States
  • University of California, Davis, Department of Orthopedic Surgery not yet accepting patients
    Sacramento California 05616 United States

Lead Scientist

  • Christopher Ames, MD
    Professor of Clinical Neurological Surgery and Orthopaedic Surgery Dr. Ames is the director of spinal deformity and spine tumor surgery and co-director of the combined high risk spine service, the Neurospinal Disorders Program, and the UCSF Spine Center. He is board certified in neurosurgery.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
International Spine Study Group Foundation
ID
NCT04194138
Study Type
Observational [Patient Registry]
Last Updated