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Eligibility
for people ages 60 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

As the population continues to age, the prevalence of spinal deformity surgery for older patients is increasing. Questions regarding the suitability of these patients to undergo large spinal procedures and whether the outcomes merit the risks involved are not well known.

Official Title

Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study

Keywords

Adult Spinal Deformity Spine Deformity Fusion Elderly SRS-22r

Eligibility

You can join if…

Open to people ages 60 years and up

  • Age 60 years or older at the time of surgery
  • Diagnosis of adult spinal deformity either in the coronal or sagittal plane requiring at the minimum a 5-level spinal fusion procedure
  • Ability to understand the content of the patient information / Informed Consent Form
  • Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
  • Signed and dated Institutional Review Board (IRB)/Ethics Committee (EC)-approved written informed consent
  • Reconsent of patients for the 5 year follow-up if required by the IRB/EC

You CAN'T join if...

  • Any previous spinal procedure (except prior decompression of a maximum of 2 levels)
  • Neurodegenerative disease or paralysis
  • Unlikely to comply with follow-up
  • Institutionalized individuals
  • Any not medically managed severe systemic disease
  • Recent history (≤ 3 months) of substance abuse (ie, recreational drugs, alcohol) or psychosocial disturbance that would preclude reliable assessment
  • Prisoner
  • Presence of active malignancy
  • Has active, overt bacterial infection, systemic or local
  • History of recent(≤ 3 months) fracture/malignancy in the spinal region
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Locations

  • University of Minnesota
    Minneapolis, Minnesota, 55454, United States
  • Washington University Orthopedics
    St. Louis, Missouri, 63110, United States
  • Toronto Western Hospital
    Toronto, Ontario, Canada
  • University of Virginia
    Charlottesville, Virginia, 22903, United States
  • New York Presbyterian - Columbia University Medical Center
    New York, New York, 10032, United States
  • Hamamatsu University School of Medicine
    Hamamatsu, Japan
  • Rigshospitalet
    Copenhagen, Denmark
  • St. Maartens Kliniek
    Nijmegen, Netherlands
  • Hospital Vall d'Hebron
    Barcelona, Spain
  • Queen Mary Hospital
    Hong Kong, China
  • Nanjing University Medical School
    Nanjing, China
  • Aciboden Maser Hospital
    Istanbul, Turkey

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AOSpine International
ID
NCT02035280
Lead Scientist
Sigurd Berven
Study Type
Observational
Last Updated
February 1, 2017