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

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.

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