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NCT Number: NCT02949245

Neurologic Complications in Spinal Deformity Surgery - Extension

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.

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Key information

Conditions

Adult Spinal Deformity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Toronto Hospital, Toronto, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interventions

Procedure

Procedure/Surgery: Routinely performed surgical correction of spinal deformity

Routinely performed surgical correction of spinal deformity

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AO Foundation, AO Spine

Other

Collaborators

  • Scoliosis Research Society

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2016
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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