Clinical trial NCT04194138: Complex Adult Deformity Surgery (CADS)
Official title: Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Spinal Deformity
Scoliosis
Kyphosis
Sagittal Imbalance
Keywords: Scoliosis
Kyphosis
Sagittal Imbalance
Spinal deformity
Lead sponsor: International Spine Study Group Foundation
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Globus Medical Inc
name: SI-BONE, Inc.
First posted: 2019-12-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients.

Brief 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.

Detailed description: 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.

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

Eligibility criteria: 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:

   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:

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

Primary outcomes:
measure: Scoliosis Research Society (SRS) 22r
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Oswestry Disability Index (ODI)
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Radiographic Evaluation
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Visual Analog Scale - Back Pain
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Visual Analog Scale - Leg Pain
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Secondary outcomes:
measure: Edmonton Frail Scale
timeFrame: Change from Preop to 3months and 1, 2, 5 & 10 year follow-up
measure: Canadian Study of Health and Aging (CSHA)
timeFrame: Change from Preop to 3months and 1, 2, 5 & 10 year follow-up
measure: Adverse Events
timeFrame: 3 months and 1, 2, 5 & 10 year post treatment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Shiley Center for Orthopaedic Research and Education at Scripps Clinic
state: California
city: Sacramento
country: United States
facility: University of California, Davis, Department of Orthopedic Surgery
state: California
city: San Francisco
country: United States
facility: UCSF, Department of Neurosurgery
state: California
city: Denver
country: United States
facility: Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
state: Colorado
city: Kansas City
country: United States
facility: University of Kansas, Department of Orthopedic Surgery
state: Kansas
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins University, Department of Orthopedic Surgery
state: Maryland
city: Saint Louis
country: United States
facility: Washington University, Department of Orthopedic Surgery
state: Missouri
city: New York
country: United States
facility: NYU, Department of Orthopedics
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery, Department of Orthopedic Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Providence
country: United States
facility: University Orthopedics
state: Rhode Island
city: Dallas
country: United States
facility: Medical City Spine Hospital - Southwest Scoliosis Institute
state: Texas
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: Toronto Western
state: Ontario
Study officials:
affiliation: Denver International Spine Center
name: Shay Bess, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University, Department of Orthopedic Surgery
name: Lawrence Lenke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University, Departments of Neurosurgery and Orthopaedic Surgery
name: Christopher Shaffrey, MD
role: PRINCIPAL_INVESTIGATOR
References: