Prospective Evaluation of Elderly Deformity Surgery

Completed

Conditions studied: Adult Spinal Deformity

In brief

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.

Key facts

Study ID

NCT02035280

Run by

AO Foundation, AO Spine

People needed

233

Starts

2013-12-01

Expected to finish

2022-12-01

Last updated by the study team

2023-07-28

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

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

Full record on ClinicalTrials.gov

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