Neurologic Complications in Spinal Deformity Surgery - Extension

NCT ID: NCT02949245

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-17
• Study Completion Date: 2019-12-28

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

Conditions

Adult Spinal Deformity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Groups/Cohorts

Surgical treatment

This observational study is examining the outcomes of standard surgical treatments for adult spinal deformity.

Interventions

Intervention Type: PROCEDURE

Procedure/Surgery: Routinely performed surgical correction of spinal deformity

Routinely performed surgical correction of spinal deformity

Interventions

Interventions

Procedure/Surgery: Routinely performed surgical correction of spinal deformity

Routinely performed surgical correction of spinal deformity

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scoliosis Research Society

OTHER

Sponsor Role: collaborator

AO Foundation, AO Spine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Lenke, MD

Role: PRINCIPAL_INVESTIGATOR

Scoliosis Research Society

Locations

University of California

San Francisco, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Department of Orthopaedic Surgery, Washington University School of Medicine

St Louis, Missouri, United States

NYU School of Medicine

New York, New York, United States

University of Virginia

Charlottesville, Virginia, United States

University of Toronto Hospital

Toronto, Ontario, Canada

University of Hong Kong

Hong Kong, , China

Nanjing Drum Tower Hospital

Nanjing, , China

Hamamatsu University School of Medicine

Hamamatsu, , Japan

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

University Hospital Nottingham, NHS Trust

Nottingham, , United Kingdom

Countries

United States; Canada; China; Japan; Spain; United Kingdom

Related Links

http://www.aospine.org

Related Info

http://www.srs.org/

Related Info

Other Identifiers

Scoli-RISK-1 extension

Identifier Type: -

Identifier Source: org_study_id