Spine FusionSPSG RegistryNCT04839783
Single Position Spine Surgery Registry
An observational study of Spine Fusion and Spinal Stenosis, run by Spine and Scoliosis Research Associates at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spine Fusion, Spinal Stenosis, Degenerative Disc Disease
- How many people
- 234 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Jul 2020to 7 Jul 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from spinal conditions for which a spine surgeon has recommended an anterior posterior fusion, who meet all inclusion and no exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Austin Spine
Austin, Texas, 78626
New England Baptist Hospital
Boston, Massachusetts, 02120
NYU Langone Health
New York, New York, 10016
The Spine Clinic of Oklahoma City
Oklahoma City, Oklahoma, 73114
Atlantic Neurosurgical and Spine Specialists
Wilmington, North Carolina, 28401
About this study
Official title: Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
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.
Read the 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.
- Conditions
- Spine Fusion, Spinal Stenosis, Degenerative Disc Disease
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Interference.
Measured: 10 years
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Intensity
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Pain Intensity.
Measured: 10 years
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Depression
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Depression.
Measured: 10 years
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Anxiety
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates more Anxiety.
Measured: 10 years
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Physical Function Scores
Assess the difference between pre-op and post-op scores. Scores range from 0-100. A higher number indicates less Physical Function.
Measured: 10 years
Difference in Radiographic Measurements-Cobb Angles
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.
Measured: 10 years
Difference in Radiographic Measurements-Fractional Curve Cobb Angles
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.
Measured: 10 years
Difference in Radiographic Measurements-C7 Sagittal Vertical Alignment (SVA)
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.
Measured: 10 years
Difference in Radiographic Measurements-Coronal Sagittal Vertical Alignment (SVA)
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.
Measured: 10 years
Difference in Radiographic Measurements-Pelvic Incidence (PI)
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.
Measured: 10 years
Difference in Radiographic Measurements-Pelvic Tilt (PT)
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.
Measured: 10 years
Difference in Radiographic Measurements-Lumbar Lordosis (LL)
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.
Measured: 10 years
Difference in Radiographic Measurements-T1 Pelvic Angle (TPA)
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.
Measured: 10 years
Revision Incidence
Determine the incidence of spine surgery revisions after the initial surgery.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start7 Jul 2020
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Why it stopped: Previously allocated resources had to be redirected, at multiples sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Spine and Scoliosis Research Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839783
- Sponsor's protocol ID
- 20201713
- Acronym
- SPSG Registry
- Status last verified
- Oct 2025
- First submitted
- 10 Mar 2021
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Single Position, Spine Surgery Outcomes Registry
- ClinicalTrials.gov ID
- NCT04839783
- Acronym / sponsor ID
- SPSG Registry / 20201713
- Conditions
- Spine Fusion, Spinal Stenosis, Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Previously allocated resources had to be redirected, at multiples sites.
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Spine and Scoliosis Research AssociatesUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from spinal conditions for which a spine surgeon has recommended an anterior posterior fusion, who meet all inclusion and no exclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Revision Incidence
Time frame: 10 years
Determine the incidence of spine surgery revisions after the initial surgery.
Results and safety
The study was stopped early (reason given: Previously allocated resources had to be redirected, at multiples sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fusion and Spinal Stenosis, run by Spine and Scoliosis Research Associates at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Previously allocated resources had to be redirected, at multiples sites.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Patient-Reported Outcomes Measurement Information System (PROMIS) Domain-Pain Interference (time frame: 10 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.