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Trial record 9 of 22 for:    aospine

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 : January 13, 2020
Sponsor:
Collaborator:
AOCID
Information provided by (Responsible Party):
AOSpine International

Tracking Information
First Submitted Date December 19, 2013
First Posted Date January 14, 2014
Last Update Posted Date January 13, 2020
Study Start Date December 2013
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 21, 2018)
  • 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.
  • EuroQoL5 (EQ-5D). [ Time Frame: Baseline, 10 weeks, 12 months, 24 months, 5 years ]
    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.
  • 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 ]
    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.
Original Secondary Outcome Measures
 (submitted: January 13, 2014)
  • Treatment-related adverse events [ Time Frame: Surgery, 10 weeks, 12 months, 24 months ]
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Evaluation of Elderly Deformity Surgery
Official Title Prospective Evaluation of Elderly Deformity Surgery: A Prospective Observational, Multicenter Study
Brief 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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Elderly patients undergoing elective surgery for spinal deformity
Condition Adult Spinal Deformity
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 6, 2017)
233
Original Estimated Enrollment
 (submitted: January 13, 2014)
225
Estimated Study Completion Date December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   China,   Denmark,   Japan,   Netherlands,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02035280
Other Study ID Numbers PEEDS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AOSpine International
Study Sponsor AOSpine International
Collaborators AOCID
Investigators
Principal Investigator: Stephen Lewis, MD University of Toronto
Principal Investigator: Sigurd Berven, MD University of California, San Francisco
PRS Account AOSpine International
Verification Date December 2018