ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity (NCT02058238) | Clinical Trial Compass
WithdrawnNot Applicable
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Stopped: Sponsor Decision
United States0Started 2014-10-03
Plain-language summary
To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
✓. Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
✓. Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
✓. Patient capable of complying with study requirements
✓. Signed informed consent by patient
Exclusion criteria
✕. Infection or malignancy
✕. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
✕. Primary muscle diseases, such as muscular dystrophy