Neurologic Complications in Spinal Deformity Surgery - Extension

Evaluation of Neurologic Complications Associated With Surgical Correction of Adult Spinal Deformity (Scoli-RISK-1): A Prospective, Observational, Multi-center Study 5 Year Follow-up Extension

272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurological complications in the form of new motor and sensory deficits were monitored prospectively in all patients at hospital discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the surgery. The relationship to the surgical intervention was assessed in all new deficits.

Regression analyses were used to evaluate the association between patient demographics, co-morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery.

All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year FU visit.

Study Overview

• Status: Completed
• Conditions: Adult Spinal Deformity
• Intervention / Treatment: Procedure: Interventions

Detailed Description

Although the incidence of complications in patients undergoing correction of their spinal deformity has been reported extensively, the majority of these studies were retrospective. There were only five studies, three from a single institution, with prospectively collected data that specifically identified complications. The largest series was from Buchowski et al who reported on 108 patients with fixed sagittal deformity undergoing Pedicle Subtraction Osteotomy (PSO) with a 14% over-all complication rate with motor weakness in 11 patients and neurogenic bladder in one patient, of which 3 were permanent. Yang reported on 35 patients undergoing PSOs with a 46% over-all complication rate and one transient nerve root motor deficit. As in 2002 reported on 83 patients undergoing various osteotomies for sagittal imbalance and reported a 34% over-all complication rate with 3 permanent and 3 transient nerve root deficits.

Given this lack of information, there is a need to determine the true incidence of complications using a prospective multi-center design. There is a need to identify neurologic deficits in a more systematic fashion to include spinal cord, cauda equina and nerve root deficits as well as radiculopathies. The risk factors associated with the occurrence of a complication, especially a neurologic complication, also needs to be more fully elucidated. This is increasingly relevant, as newer surgical techniques allow for more aggressive correction of the spinal deformity that may put the spinal cord and nerve roots at increased risk. Valid data on the incidence and types of neurologic deficits is also needed in order to study newer drugs that are available that may mitigate this risk.

The primary objectives of this study are: (i) to establish the incidence of neurologic deficit in "high risk" adult patients undergoing correction of their spinal deformity of adult spinal deformity and (ii) to identify characteristics associated with increased risk of neurologic complications. Secondary objectives include (i) to determine the incidence of all complications related to surgical correction of "high risk" adult spinal deformity; (ii) to determine the short-term clinical outcomes in patients undergoing correction of their spinal deformity and (iii).to determine amount of radiographic and clinical correction of deformity

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • University of Toronto Hospital
• China
  • Hong Kong, China, 102
    • University of Hong Kong
  • NanJing, China, 210008
    • Nanjing Drum Tower Hospital
• Japan
  • Hamamatsu, Japan, 3192
    • Hamamatsu University School of Medicine
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • University Hospital Nottingham, NHS Trust
• United States
  • California
    • San Francisco, California, United States, 94118
      • University of California
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Department of Orthopaedic Surgery, Washington University School of Medicine
  • New York
    • New York, New York, United States, 10023
      • NYU School of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participant completed Scoli-RISK-1 study are potential subjects for this observational study.

Description

Inclusion Criteria:

• Participant completed Scoli-RISK-1 study (no withdraws or drop-outs)
• Signed informed consent for extended study

Exclusion Criteria:

• Subjects enrolled in Scoli-RISK-1 which are unlikely to comply with the FU
• Subjects which by law are not eligible to participate any longer in clinical trials

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Groups/Cohorts; Surgical treatment This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity.	Procedure: Interventions; Procedure/Surgery: Routinely performed surgical correction of spinal deformity Routinely performed surgical correction of spinal deformity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of neurologic complication	Rate of treatment-related neurological complications determined by the Clinical Endpoint Committee (CEC) whether complications are of neurological nature or not.	5 years postoperative
Absolute change in motor status as measured by the ASIA LEMS		between baseline and 5 years postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASIA Sensory Score	Sensory status as measured by the ASIA Sensory Score	Change between baseline and 5 years postoperative
ASIA Impairment Scale	Neurological status as measured by the ASIA Impairment Scale	Change between baseline and 5 years postoperative
SRS-22R	Function, pain and self-image as measured by the SRS-22R	Change between baseline and 5 years postoperative
ODI v2.1a	Functional impairment as measured by the ODI v2.1a score	Change between baseline and 5 years postoperative
SF-36 v2.0	Quality of life as measured by the SF-36 v2.0	Change between baseline and 5 years postoperative
Radiographic measures	major coronal curve, coronal balance, sagital alignment, T2-T12 sagital cobb, T12-S1 sagital cobb, major sagital curve	Change between baseline and 5 years postoperative

Collaborators and Investigators

• Sponsor: AO Foundation, AO Spine
• Collaborators: Scoliosis Research Society
• Investigators: Principal Investigator: Lawrence Lenke, MD, Scoliosis Research Society

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Actual): December 28, 2019
• Study Completion (Actual): December 28, 2019

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Prospective Studies; Spine; Deformity; Neurologic deficit
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Scoli-RISK-1 extension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No