Clinical trial NCT04888104: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Spinal Deformity
Scoliosis
Kyphosis
Keywords: Scoliosis
Kyphosis
Sagittal Imbalance
Lead sponsor: International Spine Study Group Foundation
Sponsor class: OTHER
Collaborators: name: NuVasive
First posted: 2021-05-17
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multicenter, prospective, observational, study evaluating the safety and performance of the VersaTie System by comparing 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

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Scoliosis Research Society (SRS) 22r
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Oswestry
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Patient-Reported Outcome Measurement Information System (PROMIS) - Social Role
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Visual Analog Scale - Back Pain
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Visual Analog Scale - Leg Pain
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
Secondary outcomes:
measure: Edmonton Frail Scale
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Canadian Study of Health and Aging (CSHA)
timeFrame: Change from Preop to 3 months and 1, 2, 5 & 10 year follow-up
measure: Adverse Events
timeFrame: 3 months and 1, 2, 5 & 10 year post treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: La Jolla
country: United States
facility: Shiley Center for Orthopaedic Research and Education at Scripps Clinic
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Denver
country: United States
facility: Presbyterian/St. Luke's Medical Center
state: Colorado
city: Shreveport
country: United States
facility: Louisiana Spine Institute
state: Louisiana
city: Buffalo
country: United States
facility: University at Buffalo, Department of Neurosurgery
state: New York
city: New York
country: United States
facility: New York University, Department of Orthopedic Surgery
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Presbyterian/St Luke's Medical Center
name: Shay Bess, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo, Department of Neurosurgery
name: Jeffrey Mullin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center, Section of Spine Surgery
name: Christopher Shaffrey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Medical Center, Department of Neurosurgery
name: Justin Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: