Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04194138
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2019-11-25
Brief Title:
Complex Adult Deformity Surgery CADS
Sponsor:
International Spine Study Group Foundation
Organization:
International Spine Study Group Foundation
Study Overview
Official Title:
Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery
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:
CADS
Brief Summary:
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity ASD patients 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 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 identified in an analysis of the existing ISSG ASD database i Magnitude of coronal andor sagittal spinal deformity 75th percentile of patients in the ISSG database
ii Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery andor patients that had hospital length of stay 9 days
iii Procedures involving 3 column osteotomies andor anterior column reconstruction ACR of the spine
Develop and validate a standardized universal complications classification system for spine surgery
Evaluate perioperative blood management approaches transfusion requirements including variance in thresholds for blood transfusion and associated complications for adult spinal deformity surgery
Assess impact of opioid use and pain management on patient cost complications and outcomes
Evaluate optimal opioid and analgesic usage and protocols for standard work development
Evaluate clinical outcomes utilizing legacy patient reported outcome measures PROMs including modified Oswestry Disability Index mODI Scoliosis Research Society Questionnaire 22r SRS-22r Veterans RAND-12 VR-12 and numeric pain rating scale NRS and compare the results of these legacy PROMs to outcomes scores as measured by the NIH Patient Reported Outcomes Measurement Information System PROMIS - PROMIS Anxiety Depression Pain Interference Physical Function and Social Satisfaction Secondary aims for PROM research for this study include
1 Validation of the PROMIS tool for ASD
2 Establish a core set of PROMs for best practice guidelines for ASD
3 Evaluate patient reported outcome variance for ASD according to SRS-Schwab spine deformity type including variance in baseline PROM domains impacted and variance in improvement in PROM domains
4 Evaluate ASD outcomes compared to population norms and investigatedevelop appropriate measures of clinically significant improvement
Evaluate clinical outcomes stratifying by patient chronological and physiological age
Evaluate measures to quantify patient physiological age including patient frailty for ASD and validate a frailty measurement system for ASD
Evaluate the role of functional tests in patients baseline frailty assessment including hand manometer and Edmonton Frail Scale See appendix pages 17 18 for details
Evaluate the contribution of patient frailty to patient outcomes cost of care disability and complications
Evaluate if patient frailty is a static measure or if frailty is a dynamic measure that can be improved through pre-habilitation and if the according associations with reductions in frailty correlate with reductions of cost complications and improvement in outcomes
Evaluate cost variance for ASD surgery according to patient institution and geographical region and evaluate the cost effectiveness of surgical intervention for ASD
Evaluate incidence of and risk factors for mental health MH compromise among ASD patients and establish best practice guidelines for assessing MH for ASD patients
Evaluate the association of MH with surgical complications outcomes hospital length of stay and cost for ASD surgery
Evaluate the association of social health surgical complications outcomes hospital length of stay and cost for ASD surgery and risk factors for routine home discharge vs skilled nursing facility SNFrehabilitation facility
Broaden the evaluation of the 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 surgical treatment of ASD
Develop predictive analytic algorithms to risk stratify for bestworst outcomes complications sentinel events and economic loss for ASD surgery
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity ASD patients 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 identified in an analysis of the existing ISSG ASD database i Magnitude of coronal andor sagittal spinal deformity 75th percentile of patients in the ISSG database
ii Clinical or Radiographic parameters that corresponded to patients in the ISSG database that had complications requiring revision spine surgery andor patients that had hospital length of stay 9 days
iii Procedures involving 3 column osteotomies andor anterior column reconstruction ACR of the spine
Develop and validate a standardized universal complications classification system for spine surgery
Evaluate perioperative blood management approaches transfusion requirements including variance in thresholds for blood transfusion and associated complications for adult spinal deformity surgery
Assess impact of opioid use and pain management on patient cost complications and outcomes
Evaluate optimal opioid and analgesic usage and protocols for standard work development
Evaluate clinical outcomes utilizing legacy patient reported outcome measures PROMs including modified Oswestry Disability Index mODI Scoliosis Research Society Questionnaire 22r SRS-22r Veterans RAND-12 VR-12 and numeric pain rating scale NRS and compare the results of these legacy PROMs to outcomes scores as measured by the NIH Patient Reported Outcomes Measurement Information System PROMIS - PROMIS Anxiety Depression Pain Interference Physical Function and Social Satisfaction Secondary aims for PROM research for this study include
1 Validation of the PROMIS tool for ASD
2 Establish a core set of PROMs for best practice guidelines for ASD
3 Evaluate patient reported outcome variance for ASD according to SRS-Schwab spine deformity type including variance in baseline PROM domains impacted and variance in improvement in PROM domains
4 Evaluate ASD outcomes compared to population norms and investigatedevelop appropriate measures of clinically significant improvement
Evaluate clinical outcomes stratifying by patient chronological and physiological age
Evaluate measures to quantify patient physiological age including patient frailty for ASD and validate a frailty measurement system for ASD
Evaluate the role of functional tests in patients baseline frailty assessment including hand manometer and Edmonton Frail Scale See appendix pages 17 18 for details
Evaluate the contribution of patient frailty to patient outcomes cost of care disability and complications
Evaluate if patient frailty is a static measure or if frailty is a dynamic measure that can be improved through pre-habilitation and if the according associations with reductions in frailty correlate with reductions of cost complications and improvement in outcomes
Evaluate cost variance for ASD surgery according to patient institution and geographical region and evaluate the cost effectiveness of surgical intervention for ASD
Evaluate incidence of and risk factors for mental health MH compromise among ASD patients and establish best practice guidelines for assessing MH for ASD patients
Evaluate the association of MH with surgical complications outcomes hospital length of stay and cost for ASD surgery
Evaluate the association of social health surgical complications outcomes hospital length of stay and cost for ASD surgery and risk factors for routine home discharge vs skilled nursing facility SNFrehabilitation facility
Broaden the evaluation of the 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 surgical treatment of ASD
Develop predictive analytic algorithms to risk stratify for bestworst outcomes complications sentinel events and economic loss for ASD 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