Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
NCT ID: NCT04885244
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2021-07-28
2034-12-31
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 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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
2. Active spine tumor or infection
3. Patient is unwilling or unable to complete questionnaires
4. Women who are pregnant
5. Prisoners -
18 Years
ALL
No
Sponsors
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NuVasive
INDUSTRY
International Spine Study Group Foundation
OTHER
Responsible Party
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Principal Investigators
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Praveen Mummaneni, MD
Role: PRINCIPAL_INVESTIGATOR
University of San Francisco
Paul Park, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Gregory Mundis, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA
Juan Uribe, MD
Role: PRINCIPAL_INVESTIGATOR
Barrow Neurological Institute, Phoenix, AZ
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California - San Francisco Medical Center
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Rush University, Department of Neurosurgery
Chicago, Illinois, United States
Louisiana Spine Institute
Shreveport, Louisiana, United States
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, United States
Columbia University - New York-Presbyterian Och Spine Hospital
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Semmes-Murphey
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2138
Identifier Type: -
Identifier Source: org_study_id
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