Prospective Evaluation of Elderly Deformity Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02035280|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : November 20, 2017
|Condition or disease|
|Adult Spinal Deformity|
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|
|Actual Enrollment :||233 participants|
|Official Title:||Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||September 2022|
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.
- 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.
- 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, 5 years ]
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.
- Quality of life [ Time Frame: Baseline, 10 weeks, 12 months, 24 months, 5 years ]
The outcome measure is the absolute change between baseline, the 24-month and 5-year 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, 5 years ]
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).
- 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, 5 years ]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, 5 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035280
|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|
|Saint 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|
|Toronto Western Hospital|
|Toronto, Ontario, Canada|
|Queen Mary Hospital|
|Hong Kong, China|
|Nanjing University Medical School|
|Hamamatsu University School of Medicine|
|St. Maartens Kliniek|
|Hospital Vall d'Hebron|
|Aciboden Maser Hospital|
|Principal Investigator:||Stephen Lewis, MD||University of Toronto|
|Principal Investigator:||Sigurd Berven, MD||University of California, San Francisco|