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| Name | Class |
|---|---|
| NuVasive | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Index or spine revision surgery for complex adult spinal deformity | Procedure | Surgical interventions will be patient specified by treating surgeon. |
|
| 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 |
| Oswestry Disability Index (ODI) | Spine 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 |
| 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 |
| 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) |
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Inclusion Criteria:
>18 years of age at the time of treatment
Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity
EOS full body or standing 36" AP & Lateral images of entire spine
Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected)
AND Either:
One of the following Radiographic criteria:
One of the Following Procedural criteria:
Exclusion Criteria:
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Multi-center, prospective, non-randomized analysis of surgically treated complex adult spinal deformity (ASD) patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Baldus, MS | Contact | 6184444130 | baldusc@wustl.edu | |
| Ray Pinteric | Contact | ray.pinteric@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Praveen Mummaneni, MD | University of San Francisco | Principal Investigator |
| Paul Park, MD | Semmes-Murphey Clinic | Principal Investigator |
| Gregory Mundis, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Recruiting | Phoenix | Arizona | 85013 | United States |
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| 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 |
| Radiographic Evaluation | Cobb angles, Coronal & Sagittal balance, spinopelvic measures | 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 |
| 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 |
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] |
| Scripps Clinic, Department of Orthopedic Surgery, La Jolla, CA |
| Principal Investigator |
| Juan Uribe, MD | Barrow Neurological Institute, Phoenix, AZ | Principal Investigator |
| Shiley Center for Orthopaedic Research and Education at Scripps Clinic | Recruiting | La Jolla | California | 92037 | United States |
|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| University of California - San Francisco Medical Center | Recruiting | San Francisco | California | 94143 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33125 | United States |
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| Rush University, Department of Neurosurgery | Recruiting | Chicago | Illinois | 60612 | United States |
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| Louisiana Spine Institute | Recruiting | Shreveport | Louisiana | 71101 | United States |
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| University of Michigan, Department of Neurosurgery | Completed | Ann Arbor | Michigan | 48109 | United States |
| Columbia University - New York-Presbyterian Och Spine Hospital | Recruiting | New York | New York | 10034 | United States |
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| Duke University Health System | Recruiting | Durham | North Carolina | 27710 | United States |
|
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Semmes-Murphey | Recruiting | Memphis | Tennessee | 38120 | United States |
|
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D007738 | Kyphosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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