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.
≥ 18 years of age at the time surgery
Underwent thoracolumbar spinal fusion with bilateral screws at the UIV
Construct <4 levels ending at the sacrum may be treated with or without pelvic fixation
Constructs ≥4 levels ending at the sacrum must include pelvic fixation
Treated for high grade (grade III, IV, or V) spondylolisthesis
Diagnosed with primary or metastatic tumor involving the spine, history of spinal malignancy, or active cancer at the time of surgery
Adults (≥18 years of age) who previously underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV), with or without pelvic fixation, and who have a minimum of 12 months of postoperative follow-up imaging. Eligible patients will be identified retrospectively from participating U.S. sites and evaluated for UIV screw loosening and related outcomes using existing clinical and radiographic records.
Cohort
Retrospective
Not listed
UIV Screw Loosening Rate
Rate of UIV screw loosening as assessed on x-rays
Adverse Events Associated with UIV Screws
Adverse events reported that were related to the screws at the UIV
Rate of Subsequent Surgical Intervention Involving the UIV
Rate of subsequent surgical intervention including the UIV level
Rate of UIV Screw Removal
Rate of UIV screw removal
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
SI-BONE, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
