Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04885244
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2021-05-10
Brief Title:
Prospective Evaluation of Complex Adult Spinal Deformity CAD Treated With Minimally Invasive Surgery
Sponsor:
International Spine Study Group Foundation
Organization:
International Spine Study Group Foundation
Study Overview
Official Title:
Prospective Evaluation of Complex Adult Spinal Deformity CAD Treated With Minimally Invasive Surgery MIS
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIS
Brief 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 andor 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 SNFrehabilitation 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 beforeafter complex adult spinal deformity surgery
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 andor 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 SNFrehabilitation 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 beforeafter complex adult spinal deformity surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None