Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients

Scoliosis Clinical Trial

Official title:

Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888104
• Other study ID #: 2139
• Status: Recruiting
• Start date: July 9, 2021
• Est. completion date: December 31, 2034

Study information

• Verified date: March 2024
• Source: International Spine Study Group Foundation
• Contact: Christine Baldus, MH
• Phone: 6184444130
• Email: baldusc[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, Multicenter, Case-Control Analysis of the VersaTie Posterior Fixation System to Prevent Proximal Junctional Failure in Long Posterior Spinal Fusion Constructs for Adult Patients

Description:

Specific Aims:

• Evaluate the safety and performance of posterior spinal fusion constructs supplemented with posterior spinolaminar fixation using the VersaTie System compared to posterior fixation constructs without VersaTie System supplementation in adult patients undergoing long posterior spinal fusion by evaluating intraoperative and postoperative complications, clinical and radiographic outcomes, patient-reported outcomes (PROs) and need for revision 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.

• 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 investigate/develop 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 patient's 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, complications, 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 (SNF)/rehabilitation 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 best/worst outcomes, complications, sentinel events, and economic loss for ASD surgery

• Evaluate the prevalence and incidence of sacroiliac pain before/after complex adult spinal deformity surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2034
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. >18 years of age at the time of treatment

2. EOS full body or standing 36" AP & Lateral images of entire spine

3. Posterior spine fusion with pedicle screw fixation construct of 5 or more levels

4. Pedicle screw fixation to be supplemented proximally with NuVasive VersaTie system

5. Upper instrumented vertebra (UIV) terminating at a newly instrumented level

6. Lowest instrumented vertebra (LIV) sacrum/pelvis

7. Surgery scheduled to take place in the next 6 months

Exclusion Criteria:

1. Active spine tumor or infection

2. Deformity due to acute trauma

3. Prisoners

4. Women who are pregnant

5. Patient is unwilling or unable to complete questionnaires

Related Conditions & MeSH terms

• Adult Spinal Deformity
• Kyphosis
• Scoliosis

Intervention

Procedure:
• Index or revision spine surgery for complex adult spinal deformity
Adult patients receiving minimum 5 level posterior spinal fusion with pedicle screw fixation supplemented at the proximal aspect of the construct with the VersaTie System.

Locations

Country	Name	City	State
United States	University at Buffalo, Department of Neurosurgery	Buffalo	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Presbyterian/St. Luke's Medical Center	Denver	Colorado
United States	Duke University Health System	Durham	North Carolina
United States	Shiley Center for Orthopaedic Research and Education at Scripps Clinic	La Jolla	California
United States	New York University, Department of Orthopedic Surgery	New York	New York
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	University of California - San Francisco	San Francisco	California
United States	Louisiana Spine Institute	Shreveport	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
International Spine Study Group Foundation	NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scoliosis Research Society (SRS) 22r	Scoliosis specific patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Oswestry	Spine specific patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Veterans RAND 12 Item Health Survey (VR-12)	Patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety	Patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Depression	Patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference	Patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function	Patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction	Patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role	Patient reported outcome	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Visual Analog Scale - Back Pain	Self-reported back pain on scale of 0 (No pain) to 10 (severe pain)	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Primary	Visual Analog Scale - Leg Pain	Self-reported leg pain on scale of 0 (No pain) to 10 (severe pain)	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Secondary	Edmonton Frail Scale	Evaluate frailty on scale of 0 to 17 where higher scores mean more frail	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Secondary	Canadian Study of Health and Aging (CSHA)	Frailty scale of 1 to 9; higher scores mean more frail	Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Secondary	Adverse Events	Occurrence of Adverse events meeting reporting criteria and their relationship to intervention throughout the study; [Time Frame: 3 months and 1, 2, 5 & 10 year post treatment]	3 months and 1, 2, 5 & 10 year post treatment