Clinical trial NCT04885244: Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
Official title: Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)
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: NuVasive
First posted: 2021-05-13
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 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: 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.

Eligibility criteria: 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 -

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: 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 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 Role Satisfaction
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: 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 3 months and 1, 2, 5 & 10 year follow-up]
measure: Canadian Study of Health and Aging (CSHA)
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
measure: Adverse Events
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up]
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: La Jolla
country: United States
facility: Shiley Center for Orthopaedic Research and Education at Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco Medical Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Rush University, Department of Neurosurgery
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Spine Institute
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan, Department of Neurosurgery
state: Michigan
city: New York
country: United States
facility: Columbia University - New York-Presbyterian Och Spine Hospital
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes-Murphey
state: Tennessee
Study officials:
affiliation: University of San Francisco
name: Praveen Mummaneni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Paul Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA
name: Gregory Mundis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barrow Neurological Institute, Phoenix, AZ
name: Juan Uribe, MD
role: PRINCIPAL_INVESTIGATOR
References: