Single Position Spine Surgery Registry (SPSG Registry)

November 21, 2023 updated by: Spine and Scoliosis Research Associates

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.

Study Overview

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

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Windsor, Victoria, Australia, 3181
        • Recruiting
        • Melbourne Orthopedic Group
        • Principal Investigator:
          • Aaron Buckland, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Not yet recruiting
        • New England Baptist Hospital
        • Contact:
        • Principal Investigator:
          • Brian Kwon, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Sub-Investigator:
          • Themistocles Protopsaltis, MD
        • Principal Investigator:
          • Aaron Buckland, MD
        • Contact:
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Atlantic Neurosurgical and Spine Specialists
        • Contact:
        • Principal Investigator:
          • Alex Thomas, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73114
        • Recruiting
        • The Spine Clinic of Oklahoma City
        • Contact:
        • Principal Investigator:
          • Brett Braly, MD
    • Texas
      • Austin, Texas, United States, 78626
        • Not yet recruiting
        • Austin Spine
        • Contact:
        • Principal Investigator:
          • Ivan Cheng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2020

Primary Completion (Estimated)

July 7, 2030

Study Completion (Estimated)

July 7, 2032

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20201713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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