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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis; Kyphosis; Adult Spinal Deformity; Sagittal Imbalance
• Intervention / Treatment: Procedure: Index or spine revision surgery for complex adult spinal deformity

Detailed Description

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 (Estimated): 500

Contacts and Locations

• Study Contact: Name: Christine Baldus, MS; Phone Number: 6184444130; Email: baldusc@wustl.edu
• Study Contact Backup: Name: Ray Pinteric; Email: ray.pinteric@outlook.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • Barrow Neurological Institute
      • Principal Investigator: Juan Uribe, MD
      • Sub-Investigator: Jay Turner, MD
      • Contact: Luke O'Neill; Email: luke.o'neill@commonspirit.org
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Shiley Center for Orthopaedic Research and Education at Scripps Clinic
      • Contact: Tina Iannacone, MPH; Phone Number: 858-554-7124; Email: iannacone.tina@scrippshealth.org
      • Principal Investigator: Gregory Mundis, MD
      • Sub-Investigator: Robert Eastlack, MD
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Babak Khanderoo; Email: babakk70@gmail.com
      • Principal Investigator: Neel Anand, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California - San Francisco Medical Center
      • Contact: Alysha Jamieson; Email: Alysha.Jamieson@ucsf.edu
      • Principal Investigator: Praveen Mummaneni, MD
  • Florida
    • Miami, Florida, United States, 33125
      • Recruiting
      • University of Miami
      • Principal Investigator: Micahael Wang, MD
      • Contact: Adriana Saravia; Email: axf1724@med.miami.edu
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University, Department of Neurosurgery
      • Principal Investigator: Richard Fessler, MD
      • Contact: Reehan Malhance; Email: Reehan_T_Malhance@rush.edu
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Recruiting
      • Louisiana Spine Institute
      • Principal Investigator: Pierce Nunley, MD
      • Contact: Brandi Casey; Email: bcasey@louisianaspine.org
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Completed
      • University of Michigan, Department of Neurosurgery
  • New York
    • New York, New York, United States, 10034
      • Recruiting
      • Columbia University - New York-Presbyterian Och Spine Hospital
      • Principal Investigator: Dean Chou, MD
      • Contact: Vivian Le; Email: vl2518@cumc.columbia.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Health System
      • Principal Investigator: Khoi Than, MD
      • Contact: Ronald Pegues; Email: ronald.pegues@duke.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Jan Alicandro; Email: alicandroja@upmc.edu
      • Sub-Investigator: Kojo Hamilton, MD
      • Principal Investigator: David Okonkwo, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Semmes-Murphey
      • Principal Investigator: Paul Park, MD
      • Contact: Olivia House; Email: ohouse@semmes-murphey.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients

Description

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:

1. Deformity due to acute trauma
2. Active spine tumor or infection
3. Patient is unwilling or unable to complete questionnaires
4. Women who are pregnant
5. Prisoners -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Operative; 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; Surgical interventions will be patient specified by treating surgeon.

What is the study measuring?

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
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
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
Oswestry Disability Index (ODI)	Spine specific 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
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
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]

Collaborators and Investigators

• Sponsor: International Spine Study Group Foundation
• Collaborators: NuVasive
• Investigators: Principal Investigator: Praveen Mummaneni, MD, University of San Francisco; Principal Investigator: Paul Park, MD, University of Michigan; Principal Investigator: Gregory Mundis, MD, Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA; Principal Investigator: Juan Uribe, MD, Barrow Neurological Institute, Phoenix, AZ

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Scoliosis; Spinal Deformity; Kyphosis; Sagittal Imbalance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Congenital Abnormalities; Scoliosis; Kyphosis
• Other Study ID Numbers: 2138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No