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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04839783




Registration number
NCT04839783
Ethics application status
Date submitted
10/03/2021
Date registered
9/04/2021
Date last updated
4/11/2024

Titles & IDs
Public title
Single Position Spine Surgery Registry
Scientific title
Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
Secondary ID [1] 0 0
20201713
Universal Trial Number (UTN)
Trial acronym
SPSG Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spine Fusion 0 0
Spinal Stenosis 0 0
Degenerative Disc Disease 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity
Timepoint [2] 0 0
10 years
Primary outcome [3] 0 0
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression
Timepoint [3] 0 0
10 years
Primary outcome [4] 0 0
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety
Timepoint [4] 0 0
10 years
Primary outcome [5] 0 0
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores
Timepoint [5] 0 0
10 years
Primary outcome [6] 0 0
Difference in Radiographic Measurements-Cobb Angles
Timepoint [6] 0 0
10 years
Primary outcome [7] 0 0
Difference in Radiographic Measurements-Fractional Curve Cobb Angles
Timepoint [7] 0 0
10 years
Primary outcome [8] 0 0
Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA)
Timepoint [8] 0 0
10 years
Primary outcome [9] 0 0
Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA)
Timepoint [9] 0 0
10 years
Primary outcome [10] 0 0
Difference in Radiographic Measurements-Pelvic Incidence (PI)
Timepoint [10] 0 0
10 years
Primary outcome [11] 0 0
Difference in Radiographic Measurements-Pelvic Tilt (PT)
Timepoint [11] 0 0
10 years
Primary outcome [12] 0 0
Difference in Radiographic Measurements-Lumbar Lordosis (LL)
Timepoint [12] 0 0
10 years
Primary outcome [13] 0 0
Difference in Radiographic Measurements-T1 Pelvic Angle (TPA)
Timepoint [13] 0 0
10 years
Primary outcome [14] 0 0
Revision Incidence
Timepoint [14] 0 0
10 years

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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/07/2032
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Orthopedic Group - Windsor
Recruitment postcode(s) [1] 0 0
3181 - Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
Spine and Scoliosis Research Associates
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04839783
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04839783