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

Scoliosis Clinical Trial

— MIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885244
• Other study ID #: 2138
• Status: Recruiting
• Start date: July 28, 2021
• Est. completion date: December 31, 2034

Study information

• Verified date: March 2024
• Source: International Spine Study Group Foundation
• Contact: Christine Baldus, MS
• Phone: 6184444130
• Email: baldusc[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Adult Spinal Deformity
• Congenital Abnormalities
• Kyphosis
• Sagittal Imbalance
• Scoliosis

Intervention

Procedure:
• Index or spine revision surgery for complex adult spinal deformity
Surgical interventions will be patient specified by treating surgeon.

Locations

Country	Name	City	State
United States	University of Michigan, Department of Neurosurgery	Ann Arbor	Michigan
United States	Rush University, Department of Neurosurgery	Chicago	Illinois
United States	Duke University Health System	Durham	North Carolina
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	Semmes-Murphey	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Columbia University - New York-Presbyterian Och Spine Hospital	New York	New York
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California - San Francisco Medical Center	San Francisco	California
United States	Louisiana Spine Institute	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
International Spine Study Group Foundation	NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoliosis Research Society (SRS) 22r	Scoliosis specific patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Oswestry Disability Index (ODI)	Spine specific patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Radiographic Evaluation	Cobb angles, Coronal & Sagittal balance, spinopelvic measures	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	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
Primary	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	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]
Secondary	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]
Secondary	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]