Neurologic Complications in Spinal Deformity Surgery - Extension

Completed

Conditions studied: Adult Spinal Deformity

In brief

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.

Key facts

Study ID

NCT02949245

Run by

AO Foundation, AO Spine

People needed

77

Starts

2017-08-17

Expected to finish

2019-12-28

Last updated by the study team

2020-05-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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