Scoliosis Clinical Trial
Official title:
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
| Recruiting |
NCT05944393 -
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
|
N/A | |
| Recruiting |
NCT05888038 -
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
|
N/A | |
| Completed |
NCT02890654 -
Scoliosis and Quality of Life of Adolescents
|
||
| Completed |
NCT02413788 -
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
|
N/A | |
| Completed |
NCT02558985 -
Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
|
||
| Completed |
NCT02531945 -
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
|
N/A | |
| Terminated |
NCT02134704 -
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
|
N/A | |
| Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
| Completed |
NCT02285621 -
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
|
N/A | |
| Withdrawn |
NCT00768313 -
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
|
Phase 4 | |
| Completed |
NCT00155545 -
Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients
|
Phase 1 | |
| Completed |
NCT00154505 -
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
|
Phase 1 | |
| Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
| Completed |
NCT00273598 -
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
|
Phase 2 | |
| Completed |
NCT03135665 -
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
|
N/A | |
| Recruiting |
NCT04423146 -
Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
|
||
| Completed |
NCT03814239 -
Blood and Fluid Management During Scoliosis Surgery
|
||
| Withdrawn |
NCT02058238 -
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
|
||
| Completed |
NCT02904421 -
6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation
|