NCT02949245

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
6 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2.4 years

First QC Date

October 24, 2016

Last Update Submit

May 18, 2020

Conditions

Adult Spinal Deformity

Keywords

SpineSurgeryProspective StudiesDeformityNeurologic deficit

Outcome Measures

Primary Outcomes (2)

  • 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

  • Absolute change in motor status as measured by the ASIA LEMS

    between baseline and 5 years postoperative

Secondary Outcomes (6)

  • ASIA Sensory Score

    Change between baseline and 5 years postoperative

  • ASIA Impairment Scale

    Change between baseline and 5 years postoperative

  • SRS-22R

    Change between baseline and 5 years postoperative

  • ODI v2.1a

    Change between baseline and 5 years postoperative

  • SF-36 v2.0

    Change between baseline and 5 years postoperative

  • +1 more secondary outcomes

Study Arms (1)

Groups/Cohorts

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

Procedure: Interventions

Interventions

InterventionsPROCEDURE

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

Groups/Cohorts

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Participant completed Scoli-RISK-1 study (no withdraws or drop-outs)
  • Signed informed consent for extended study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California

San Francisco, California, 94118, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Department of Orthopaedic Surgery, Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

NYU School of Medicine

New York, New York, 10023, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

University of Toronto Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

University of Hong Kong

Hong Kong, 102, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Hamamatsu University School of Medicine

Hamamatsu, 3192, Japan

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

University Hospital Nottingham, NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Congenital AbnormalitiesNeurologic Manifestations

Interventions

Methods

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Lawrence Lenke, MD

    Scoliosis Research Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 31, 2016

Study Start

August 17, 2017

Primary Completion

December 28, 2019

Study Completion

December 28, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

ES(1)US(5)JP(1)GB(1)CA(1)CN(2)