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.
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.
Study Type
OBSERVATIONAL
Enrollment
233
UCSF Medical Center
San Francisco, California, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University Orthopedics
St Louis, Missouri, United States
Absolute change in the Scoliosis Research Society-22 r (SRS-22r) total score
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.
Time frame: Baseline, 10 weeks, 12 months, 24 months
Treatment-related adverse events
Time frame: Surgery, 10 weeks, 12 months, 24 months, 5 years
Oswestry Disability Index Version 2.1a (ODI)
The outcome measure is the absolute change between baseline, the 24-month and the 5-year 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.
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
EuroQoL5 (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. 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.
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
Pain (back and pain)
The outcome measure is the absolute change between baseline,the 24-month and 5 year 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).
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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
...and 3 more locations
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
Bone Mineral Density (BMD)
Baseline dual energy x-ray absorptiometry (DXA) scans of patients' BMD will only be performed at clinics where assessed as standard of care.
Time frame: Baseline
Radiological Parameters
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.
Time frame: Baseline, Surgery, 24 months, 5 years
Animal Fluency Test
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.
Time frame: Baseline, 10 weeks, 12 months, 24 months, 5 years
SRS-22r
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.
Time frame: 5 years