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.
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
234
New England Baptist Hospital
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
Atlantic Neurosurgical and Spine Specialists
Wilmington, North Carolina, United States
The Spine Clinic of Oklahoma City
Oklahoma City, Oklahoma, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 years
Difference in Radiographic Measurements-Fractional Curve Cobb Angles
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Austin Spine
Austin, Texas, United States
Melbourne Orthopedic Group
Windsor, Victoria, Australia
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 years
Revision Incidence
Determine the incidence of spine surgery revisions after the initial surgery.
Time frame: 10 years