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A Prospective Multicenter Study Evaluating the Clinical and Radiographic Outcomes of Thoracolumbar Spine Surgery When Comprehensive Sagittal Alignment Surgical Planning is Used

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:
IRB-17-6923
Gregory Mundis
A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied. This study aims to assess the value of such planning through clinical and radiographic outcomes.

Inclusion Criteria: 1. Male and female patients who are at least 18 years of age; 2. Patients with planned thoracolumbar (any number of levels between T1 and the pelvis) spine fusion surgery and available preoperative standing lateral radiographs, inclusive of the femoral head axis; 3. Able to undergo surgery based on physical exam, medical history and surgeon judgment; 4. Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the evaluation. Exclusion Criteria: 1. Patient has a mental or physical condition that would limit the ability to comply with study requirements; 2. Patient is a prisoner; 3. Patient is participating in another clinical study that would confound study data.

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

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How can I find trials that are accepting new participants?

For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.