Neurologic Complications in Spinal Deformity Surgery - Extension

• ClinicalTrials.gov Identifier: NCT02949245
• Recruitment Status: Completed
• First Posted: October 31, 2016
• Last Update Posted: May 19, 2020
• Sponsor: AO Foundation, AO Spine
• Collaborator: Scoliosis Research Society
• Information provided by (Responsible Party): AO Foundation, AO Spine

Study Description

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.

Condition or disease	Intervention/treatment
Adult Spinal Deformity	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 Design

• Study Type: Observational
• Actual Enrollment: 77 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: August 17, 2017
• Actual Primary Completion Date: December 28, 2019
• Actual Study Completion Date: December 28, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. ASIA Sensory Score [ Time Frame: Change between baseline and 5 years postoperative ]
   Sensory status as measured by the ASIA Sensory Score
2. ASIA Impairment Scale [ Time Frame: Change between baseline and 5 years postoperative ]
   Neurological status as measured by the ASIA Impairment Scale
3. SRS-22R [ Time Frame: Change between baseline and 5 years postoperative ]
   Function, pain and self-image as measured by the SRS-22R
4. ODI v2.1a [ Time Frame: Change between baseline and 5 years postoperative ]
   Functional impairment as measured by the ODI v2.1a score
5. SF-36 v2.0 [ Time Frame: Change between baseline and 5 years postoperative ]
   Quality of life as measured by the SF-36 v2.0
6. Radiographic measures [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Locations

United States, California

University of California

San Francisco, California, United States, 94118

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205

United States, Missouri

Department of Orthopaedic Surgery, Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, New York

NYU School of Medicine

New York, New York, United States, 10023

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

Canada, Ontario

University of Toronto Hospital

Toronto, Ontario, Canada, M5T 2S8

China

University of Hong Kong

Hong Kong, China, 102

Nanjing Drum Tower Hospital

NanJing, China, 210008

Japan

Hamamatsu University School of Medicine

Hamamatsu, Japan, 3192

Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 08035

United Kingdom

University Hospital Nottingham, NHS Trust

Nottingham, United Kingdom, NG7 2UH

Sponsors and Collaborators

AO Foundation, AO Spine

Scoliosis Research Society

Investigators

• Principal Investigator: Lawrence Lenke, MD; Scoliosis Research Society

More Information

Additional Information:

Related Info 

Related Info 

• Responsible Party: AO Foundation, AO Spine
• ClinicalTrials.gov Identifier: NCT02949245
• Other Study ID Numbers: Scoli-RISK-1 extension
• First Posted: October 31, 2016
• Last Update Posted: May 19, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AO Foundation, AO Spine:

Spine; Surgery; Prospective Studies; Deformity; Neurologic deficit

Additional relevant MeSH terms:

Congenital Abnormalities