Neurologic Complications in Spinal Deformity Surgery - Extension

Completed

• Conditions: Adult Spinal Deformity
• Interventions: Procedure: Interventions

• Registration Number: NCT02949245
• Lead Sponsor: AO Foundation, AO Spine

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Study Start: 2017-08-17
• Primary Completion: 2019-12-28
• Study Completion: 2019-12-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Groups/Cohorts	Interventions	Surgical treatment This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (11)

University of California; 🇺🇸 San Francisco, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Department of Orthopaedic Surgery, Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

NYU School of Medicine; 🇺🇸 New York, New York, United States

University of Toronto Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Hong Kong; 🇨🇳 Hong Kong, China

Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Japan

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

University Hospital Nottingham, NHS Trust; 🇬🇧 Nottingham, United Kingdom

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Nanjing Drum Tower Hospital; 🇨🇳 NanJing, China