Skip to main content

Summary

for people ages 60 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

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

Details

225 subjects greater than or equal 60 years of age with moderate and severe adult spinal deformity requiring surgical correction will be enrolled in a prospective multicenter international study. Spinal deformity will be defined as any coronal or sagittal plane spinal deformity in patients who have not undergone any previous spinal surgery (with the exception of prior decompression of a maximum of 2 levels) necessitating at a minimum a 5-level spinal fusion procedure. Standard radiographs and cross sectional imaging will be performed preoperatively, postoperatively, at 24 months and 5 years after surgery. Preoperative disease specific and general health questionnaires will be completed by all patients (EQ-5D, ODI, SRS-22r, NRS for back and leg pain). Follow up visits with questionnaires will be performed at 10 weeks (± 6 weeks), 12 months (± 2 months), 24 months (± 2 months) and 5 years (±6 months) post-operatively. All treatment-related AEs will be documented.

Regression analyses will be used to evaluate the association between patient demographics, comorbidities, treatment history, spinal deformity characteristics, surgical characteristics, treatment-related AEs and pre-surgical status to self-reported and radiographic outcomes after surgery.

Keywords

Adult Spinal Deformity Spine Deformity Fusion Elderly SRS-22r Congenital Abnormalities

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

  • UCSF Medical Center
    San Francisco, California, 94118, United States
  • University of Minnesota
    Minneapolis, Minnesota, 55454, United States
  • Washington University Orthopedics
    Saint 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
November 17, 2017