Single Position Spine Surgery Registry

Last updated: November 1, 2024
Sponsor: Spine and Scoliosis Research Associates
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Spinal Stenosis

Treatment

N/A

Clinical Study ID

NCT04839783
20201713
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 withcomprehensive participation in this study

  5. Subjects with psychiatric pathology which may impair judgement or the ability togive informed consent.

Study Design

Total Participants: 1000
Study Start date:
July 07, 2020
Estimated Completion Date:
July 07, 2032

Study 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.

Connect with a study center

  • Melbourne Orthopedic Group

    Windsor, Victoria 3181
    Australia

    Active - Recruiting

  • New England Baptist Hospital

    Boston, Massachusetts 02120
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Completed

  • Atlantic Neurosurgical and Spine Specialists

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • The Spine Clinic of Oklahoma City

    Oklahoma City, Oklahoma 73114
    United States

    Completed

  • Austin Spine

    Austin, Texas 78626
    United States

    Completed

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