Single Position Spine Surgery Registry

NCT ID: NCT04839783

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2025-07-07

Brief Summary

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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

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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

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Spine Fusion Spinal Stenosis Degenerative Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spine and Scoliosis Research Associates

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New England Baptist Hospital

Boston, Massachusetts, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Atlantic Neurosurgical and Spine Specialists

Wilmington, North Carolina, United States

Site Status

The Spine Clinic of Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Austin Spine

Austin, Texas, United States

Site Status

Melbourne Orthopedic Group

Windsor, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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20201713

Identifier Type: -

Identifier Source: org_study_id

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