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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04839783
Registration number
NCT04839783
Ethics application status
Date submitted
10/03/2021
Date registered
9/04/2021
Date last updated
22/11/2023
Titles & IDs
Public title
Single Position Spine Surgery Registry
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Scientific title
Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
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Secondary ID [1]
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20201713
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Universal Trial Number (UTN)
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Trial acronym
SPSG Registry
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spine Fusion
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Spinal Stenosis
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Degenerative Disc Disease
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference
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Assessment method [1]
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Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Interference.
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Timepoint [1]
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10 years
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Primary outcome [2]
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Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity
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Assessment method [2]
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Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Intensity.
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Timepoint [2]
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10 years
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Primary outcome [3]
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Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression
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Assessment method [3]
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Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Depression.
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Timepoint [3]
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10 years
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Primary outcome [4]
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Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety
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Assessment method [4]
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Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Anxiety.
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Timepoint [4]
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10 years
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Primary outcome [5]
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Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores
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Assessment method [5]
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Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates less Physical Function.
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Timepoint [5]
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10 years
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Primary outcome [6]
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Difference in Radiographic Measurements-Cobb Angles
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Assessment method [6]
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Assess the difference between pre-op and post-op measurements of Cobb Angles using available spinal x-rays for patients whose Cobb Angle was to be changed as part of their surgical plan.
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Timepoint [6]
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10 years
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Primary outcome [7]
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Difference in Radiographic Measurements-Fractional Curve Cobb Angles
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Assessment method [7]
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Assess the difference between pre-op and post-op measurements of Fractional Curve Cobb Angles using available spinal x-rays for patients whose Fractional Curve Cobb Angle was to be changed as part of their surgical plan.
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Timepoint [7]
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10 years
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Primary outcome [8]
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Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA)
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Assessment method [8]
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Assess the difference between pre-op and post-op measurements of C7 SVA using available spinal x-rays for patients whose C7 SVA was to be changed as part of their surgical plan.
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Timepoint [8]
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10 years
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Primary outcome [9]
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Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA)
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Assessment method [9]
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Assess the difference between pre-op and post-op measurements of Coronal SVA using available spinal x-rays for patients whose Coronal SVA was to be changed as part of their surgical plan.
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Timepoint [9]
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10 years
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Primary outcome [10]
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Difference in Radiographic Measurements-Pelvic Incidence (PI)
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Assessment method [10]
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Assess the difference between pre-op and post-op measurements of PI using available spinal x-rays for patients whose PI was to be changed as part of their surgical plan.
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Timepoint [10]
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10 years
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Primary outcome [11]
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Difference in Radiographic Measurements-Pelvic Tilt (PT)
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Assessment method [11]
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Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose PT was to be changed as part of their surgical plan.
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Timepoint [11]
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10 years
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Primary outcome [12]
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Difference in Radiographic Measurements-Lumbar Lordosis (LL)
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Assessment method [12]
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Assess the difference between pre-op and post-op measurements of spinal x-rays for patients whose LL was to be changed as part of their surgical plan.
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Timepoint [12]
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10 years
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Primary outcome [13]
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Difference in Radiographic Measurements-T1 Pelvic Angle (TPA)
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Assessment method [13]
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Assess the difference between pre-op and post-op measurements of spinal x-rays, for patients whose TPA was to be changed as part of their surgical plan.
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Timepoint [13]
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10 years
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Primary outcome [14]
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Revision Incidence
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Assessment method [14]
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Determine the incidence of spine surgery revisions after the initial surgery.
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Timepoint [14]
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10 years
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Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Ability to speak and read comfortably in English
3. Affliction by a spinal condition warranting evaluation for operative treatment
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Current incarceration
2. Individuals incapable of consenting and/or objectively responding to surveys,
irrespective of reasonable assistance
3. Women currently pregnant or expecting to become pregnant in the near future
4. Subjects participating in another research study, whose protocol would conflict with
comprehensive participation in this study
5. Subjects with psychiatric pathology which may impair judgement or the ability to give
informed consent.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/07/2032
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Orthopedic Group - Windsor
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Recruitment postcode(s) [1]
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3181 - Windsor
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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United States of America
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State/province [4]
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Oklahoma
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Country [5]
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United States of America
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State/province [5]
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Texas
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Funding & Sponsors
Primary sponsor type
Other
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Name
Spine and Scoliosis Research Associates
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to systematically, prospectively compare surgical fusion
techniques for thoracolumbar spinal fusion patients and assess long-term patient outcomes and
revision rates following surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04839783
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04839783
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