The REESE study is looking at information from past spine surgeries to learn how often screws placed at the top of a spinal fusion become loose over time. Researchers will review existing medical records and X-rays from adults who have already had thoracolumbar spinal fusion surgery. The study will also look at factors that may increase the risk of screw loosening and whether it leads to additional complications or surgeries. No new procedures, treatments, or patient visits are required because the study uses information that has already been collected during routine medical care.
The REESE (Retrospective Evaluation of Upper Instrumented Vertebrae Screw Loosening Following Spine Surgery) study is a multicenter, retrospective chart review that aims to determine the rate of screw loosening at the upper instrumented vertebra (UIV) following thoracolumbar spinal fusion surgery and identify associated risk factors. Up to 400 patients from up to 10 U.S. sites will be included. Eligible patients must be adults who underwent thoracolumbar fusion with bilateral UIV screws and have at least 12 months of postoperative imaging follow-up.
Study Type
OBSERVATIONAL
Enrollment
400
Indiana University Health
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
The Ohio State University Wexner Medical Center Hospitals
Columbus, Ohio, United States
UIV Screw Loosening Rate
Rate of UIV screw loosening as assessed on x-rays
Time frame: 12-month follow-up
Adverse Events Associated with UIV Screws
Adverse events reported that were related to the screws at the UIV
Time frame: 12-month follow-up
Rate of Subsequent Surgical Intervention Involving the UIV
Rate of subsequent surgical intervention including the UIV level
Time frame: 12-month follow-up
Rate of UIV Screw Removal
Rate of UIV screw removal
Time frame: 12-month follow-up
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