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

International Spine Study Group Foundation12 个研究点分布在 1 个国家目标入组 500 人开始时间: 2021年7月28日最近更新: 2026年2月17日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: International Spine Study Group Foundation
入组人数: 500
试验地点: 12
主要终点: Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role Satisfaction

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•>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:
•PI-LL ≥ 25 degrees
•Thoracolumbar/lumbar scoliosis ≥ 20 degrees
•PT > 30 OR
•One of the Following Procedural criteria:
•Surgery to include > 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone interbody. (Levels = vertebra (i.e. percutaneous screws at L2, L3, L4 would be eligible for posterior instrumentation and/or L3-L4, L4-L5 would be eligible as stand-alone for interbodies)
•Posterior UIV and LIV must be placed percutaneously
•Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 &/or pelvis/ilium is not)
•Staged ≥ 3 levels fused with percutaneous pedicle screws
•3 column osteotomy with percutaneous fixation
•ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws

排除标准

•Deformity due to acute trauma
•Active spine tumor or infection
•Patient is unwilling or unable to complete questionnaires
•Women who are pregnant
•Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)

研究组 & 干预措施

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.

干预措施: Index or spine revision surgery for complex adult spinal deformity (Procedure)