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Prospective Evaluation of Elderly Deformity Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AOSpine International
ClinicalTrials.gov Identifier:
NCT02035280
First received: December 19, 2013
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
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.

Condition
Adult Spinal Deformity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study

Further study details as provided by AOSpine International:

Primary Outcome Measures:
  • Absolute change in the Scoliosis Research Society-22 r (SRS-22r) total score [ Time Frame: Baseline, 10 weeks, 12 months, 24 months ]

    The primary outcome is the absolute change in the SRS-22r total score between baseline and 24-months follow-up (FU) values in patients at age 60 or older treated with major spinal reconstruction.

    The SRS-22r is a patient-reported outcome instrument and has a range from 1 (worst) to 5 (best). It contains 22 questions covering five domains: function, pain, self-image, mental health (each with 5 items), and satisfaction with treatment (2 items) and each item is scored from 1 to 5.



Secondary Outcome Measures:
  • Treatment-related adverse events [ Time Frame: Surgery, 10 weeks, 12 months, 24 months, 5 years ]
  • Oswestry Disability Index Version 2.1a (ODI) [ Time Frame: Baseline, 10 weeks, 12 months, 24 months ]

    The outcome measure is the absolute change between baseline and the 24-months FU values.

    The ODI is a patient-reported outcome measure used most commonly in patients with low back pain. It consists of 10 questions and each of the items can be scored from 0 (no disability) to 5 (maximal disability), leading to a maximum score of 50.


  • Quality of life [ Time Frame: Baseline, 10 weeks, 12 months, 24 months ]

    The outcome measure is the absolute change between baseline and the 24-months FU values as measured by the European Quality of Life 5 Dimensions (EQ-5D).

    The EQ-5D is a standardized instrument designed for self-completion to assess quality of life. It has 5 items with a three-point categorical response scale. A unique EQ-5D health state is defined by combining one level from each of the five dimensions.


  • Pain (back and pain) [ Time Frame: Baseline, 10 weeks, 12 months, 24 months ]

    The outcome measure is the absolute change between baseline and the 24-months FU values.

    Lower back and leg pain will be assessed on a visual analogue scale (NRS) which ranges from 0 (no pain) to 100 (severe pain).


  • Bone Mineral Density (BMD) [ Time Frame: Baseline ]
    Baseline dual energy x-ray absorptiometry (DXA) scans of patients' BMD will only be performed at clinics where assessed as standard of care.

  • Radiological Parameters [ Time Frame: Baseline, Surgery, 24 months ]
    Radiological paramaters (lumbar lordosis, thoracic kyphosis, sagittal vertical axis, Cobb angle) will be measured at one pre- and two post-OP timepoints from sagittal standing and coronal standing x-rays.

  • Animal Fluency Test [ Time Frame: Baseline, 10 weeks, 12 months, 24 months ]
    The animal fluency test is a diagnostic tool that is recommended for use in clinical practice for quick assessment of cognitive impairment. The patient names as many animals as possible within a 60-second time period. Fifteen or fewer animals may indicate development of cognitive impairment.

  • SRS-22r [ Time Frame: 5 years ]
    SRS-22r total score 5 years after surgery


Enrollment: 233
Study Start Date: December 2013
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elderly suffering of spine deformity
Spinal deformity patients over the age of 60 years undergoing elective surgery and requiring fusion of at least 5 levels.

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly patients undergoing elective surgery for spinal deformity
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035280

Locations
United States, California
UCSF Medical Center
San Francisco, California, United States, 94118
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Washington University Orthopedics
St. Louis, Missouri, United States, 63110
United States, New York
New York Presbyterian - Columbia University Medical Center
New York, New York, United States, 10032
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada
China
Queen Mary Hospital
Hong Kong, China
Nanjing University Medical School
Nanjing, China
Denmark
Rigshospitalet
Copenhagen, Denmark
Japan
Hamamatsu University School of Medicine
Hamamatsu, Japan
Netherlands
St. Maartens Kliniek
Nijmegen, Netherlands
Spain
Hospital Vall d'Hebron
Barcelona, Spain
Turkey
Aciboden Maser Hospital
Istanbul, Turkey
Sponsors and Collaborators
AOSpine International
Investigators
Principal Investigator: Stephen Lewis, MD University of Toronto
Principal Investigator: Sigurd Berven, MD University of California, San Francisco
  More Information

Responsible Party: AOSpine International
ClinicalTrials.gov Identifier: NCT02035280     History of Changes
Other Study ID Numbers: PEEDS 
Study First Received: December 19, 2013
Last Updated: February 6, 2017

Keywords provided by AOSpine International:
Spine
Deformity
Fusion
Elderly
SRS-22r

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 20, 2017