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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02949245
Enrollment
77
Registered
2016-10-31
Start date
2017-08-17
Completion date
2019-12-28
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Spinal Deformity

Keywords

Spine, Surgery, Prospective Studies, Deformity, Neurologic deficit

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

Interventions

PROCEDUREInterventions

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

Sponsors

Scoliosis Research Society
CollaboratorOTHER
AO Foundation, AO Spine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of neurologic complication5 years postoperativeRate 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 LEMSbetween baseline and 5 years postoperative

Secondary

MeasureTime frameDescription
ASIA Sensory ScoreChange between baseline and 5 years postoperativeSensory status as measured by the ASIA Sensory Score
ASIA Impairment ScaleChange between baseline and 5 years postoperativeNeurological status as measured by the ASIA Impairment Scale
SRS-22RChange between baseline and 5 years postoperativeFunction, pain and self-image as measured by the SRS-22R
ODI v2.1aChange between baseline and 5 years postoperativeFunctional impairment as measured by the ODI v2.1a score
SF-36 v2.0Change between baseline and 5 years postoperativeQuality of life as measured by the SF-36 v2.0
Radiographic measuresChange between baseline and 5 years postoperativemajor coronal curve, coronal balance, sagital alignment, T2-T12 sagital cobb, T12-S1 sagital cobb, major sagital curve

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026