Neurologic Complications in Spinal Deformity Surgery - Extension

Adult Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949245
• Other study ID #: Scoli-RISK-1 extension
• Status: Completed
• Start date: August 17, 2017
• Est. completion date: December 28, 2019

Study information

• Verified date: May 2020
• Source: AO Foundation, AO Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 28, 2019
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Spinal Deformity
• Congenital Abnormalities

Intervention

Procedure:
• Interventions
Procedure/Surgery: Routinely performed surgical correction of spinal deformity Routinely performed surgical correction of spinal deformity

Locations

Country	Name	City	State
Canada	University of Toronto Hospital	Toronto	Ontario
China	University of Hong Kong	Hong Kong
China	Nanjing Drum Tower Hospital	NanJing
Japan	Hamamatsu University School of Medicine	Hamamatsu
Spain	Hospital Universitari Vall D'Hebron	Barcelona
United Kingdom	University Hospital Nottingham, NHS Trust	Nottingham
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	NYU School of Medicine	New York	New York
United States	Department of Orthopaedic Surgery, Washington University School of Medicine	Saint Louis	Missouri
United States	University of California	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
AO Foundation, AO Spine	Scoliosis Research Society

Countries where clinical trial is conducted

United States,  Canada,  China,  Japan,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Absolute change in motor status as measured by the ASIA LEMS		between baseline and 5 years postoperative
Secondary	ASIA Sensory Score	Sensory status as measured by the ASIA Sensory Score	Change between baseline and 5 years postoperative
Secondary	ASIA Impairment Scale	Neurological status as measured by the ASIA Impairment Scale	Change between baseline and 5 years postoperative
Secondary	SRS-22R	Function, pain and self-image as measured by the SRS-22R	Change between baseline and 5 years postoperative
Secondary	ODI v2.1a	Functional impairment as measured by the ODI v2.1a score	Change between baseline and 5 years postoperative
Secondary	SF-36 v2.0	Quality of life as measured by the SF-36 v2.0	Change between baseline and 5 years postoperative
Secondary	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

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