NCT04885244

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: International Spine Study Group Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Adult Spinal Deformity
• Scoliosis
• Kyphosis
• Sagittal Imbalance

Interventions

Type	Name	Description
PROCEDURE	Index or spine revision surgery for complex adult spinal deformity	Surgical interventions will be patient specified by treating surgeon.

Timeline

• Start date: 2021-07-28
• Primary completion: 2034-12-31
• Completion: 2034-12-31
• First posted: 2021-05-13
• Last updated: 2026-02-17

Locations

12 sites across 1 country: United States