Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
PRIMARY OBJECTIVES:
I. Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III.
Complication rate. IV. Neurological preservation.
SECONDARY OBJECTIVES:
I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function.
III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo posterior spinal tumor resection on day 0.
ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.
After completion of study treatment, patients are followed up for 6 months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimated blood loss (EBL); in milliliters (ml)
Will be comparing means with the Wilcoxon test.
Day 0
No
Rahul Jandial, MD
Principal Investigator
City of Hope Medical Center
United States: Institutional Review Board
10115
NCT01308489
May 2012
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |