- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04839783
Single Position Spine Surgery Registry (SPSG Registry)
Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
Study Overview
Status
Conditions
Detailed Description
The goal of this study is to understand how the difference in positioning of a patient intraoperatively, as part of performing an anterior posterior spine fusion surgery, can affect short term and long term outcomes. This will be accomplished through observational techniques that will not affect the care patients will receive for their spinal conditions.
Patients will be asked to complete health and wellness surveys before and after survey to determine how they are doing before surgery and then what if any changes their respective surgeries have had on their lives. Further spine x-rays that they have taken to plan their surgeries and assess their recovery will be measured, when available. X-rays will not be taken only for research purposes. Additionally aspects of their surgeries will be noted such as where hardware is placed and how long different parts of the surgery took.
Follow-up is planned to be out to 10 years post-operatively with the goal of collecting information about any revision spine surgeries that would happen during those 10 years as well.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Victoria
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Windsor, Victoria, Australia, 3181
- Recruiting
- Melbourne Orthopedic Group
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Principal Investigator:
- Aaron Buckland, MD
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Contact:
- Aaron Buckland, MD
- Phone Number: 03 9529 3333
- Email: aaron.buckland@spineandscoliosis.org
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-
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Massachusetts
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Boston, Massachusetts, United States, 02120
- Not yet recruiting
- New England Baptist Hospital
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Contact:
- Brian Kwon, MD
- Phone Number: 617-754-6586
- Email: bkwon@nebh.org
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Principal Investigator:
- Brian Kwon, MD
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New York
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New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
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Sub-Investigator:
- Themistocles Protopsaltis, MD
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Principal Investigator:
- Aaron Buckland, MD
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Contact:
- Brooke O'Connell, MS
- Phone Number: 646-794-8643
- Email: brooke.oconnell@nyulangone.org
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North Carolina
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Wilmington, North Carolina, United States, 28401
- Recruiting
- Atlantic Neurosurgical and Spine Specialists
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Contact:
- Bridgette Smith CCRC
- Phone Number: 919-259-3449
- Email: bridgette@atlanticneurosurgery.com
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Principal Investigator:
- Alex Thomas, MD
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73114
- Recruiting
- The Spine Clinic of Oklahoma City
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Contact:
- Ashley Mason
- Phone Number: 405-419-5614
- Email: amason@okss.com
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Principal Investigator:
- Brett Braly, MD
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Texas
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Austin, Texas, United States, 78626
- Not yet recruiting
- Austin Spine
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Contact:
- Ivan Cheng, MD
- Phone Number: 650-387-3528
- Email: ivanchengmd@gmail.com
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Principal Investigator:
- Ivan Cheng, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age greater than or equal to 18 years
- Ability to speak and read comfortably in English
- Affliction by a spinal condition warranting evaluation for operative treatment
Exclusion Criteria:
- Current incarceration
- Individuals incapable of consenting and/or objectively responding to surveys, irrespective of reasonable assistance
- Women currently pregnant or expecting to become pregnant in the near future
- Subjects participating in another research study, whose protocol would conflict with comprehensive participation in this study
- Subjects with psychiatric pathology which may impair judgement or the ability to give informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference
Time Frame: 10 years
|
Assess the difference between pre-op and post-op scores.
Scores range from 0-100.
A higher number indicates more Pain Interference.
|
10 years
|
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity
Time Frame: 10 years
|
Assess the difference between pre-op and post-op scores.
Scores range from 0-100.
A higher number indicates more Pain Intensity.
|
10 years
|
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression
Time Frame: 10 years
|
Assess the difference between pre-op and post-op scores.
Scores range from 0-100.
A higher number indicates more Depression.
|
10 years
|
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety
Time Frame: 10 years
|
Assess the difference between pre-op and post-op scores.
Scores range from 0-100.
A higher number indicates more Anxiety.
|
10 years
|
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores
Time Frame: 10 years
|
Assess the difference between pre-op and post-op scores.
Scores range from 0-100.
A higher number indicates less Physical Function.
|
10 years
|
Difference in Radiographic Measurements-Cobb Angles
Time Frame: 10 years
|
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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10 years
|
Difference in Radiographic Measurements-Fractional Curve Cobb Angles
Time Frame: 10 years
|
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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10 years
|
Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA)
Time Frame: 10 years
|
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.
|
10 years
|
Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA)
Time Frame: 10 years
|
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.
|
10 years
|
Difference in Radiographic Measurements-Pelvic Incidence (PI)
Time Frame: 10 years
|
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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10 years
|
Difference in Radiographic Measurements-Pelvic Tilt (PT)
Time Frame: 10 years
|
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.
|
10 years
|
Difference in Radiographic Measurements-Lumbar Lordosis (LL)
Time Frame: 10 years
|
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.
|
10 years
|
Difference in Radiographic Measurements-T1 Pelvic Angle (TPA)
Time Frame: 10 years
|
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.
|
10 years
|
Revision Incidence
Time Frame: 10 years
|
Determine the incidence of spine surgery revisions after the initial surgery.
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10 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20201713
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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