MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
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|ClinicalTrials.gov Identifier: NCT02057744|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2014
Last Update Posted : August 20, 2019
|Condition or disease|
|Degenerative Spine Disease Spondylolisthesis Spondylosis|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive robotic-guided spinal fixation surgery.
Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive image-guided freehand or navigated spinal fixation surgery.
- Intra-operative exposure to x-ray radiation [ Time Frame: Day of surgery ]Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.
- Surgical complications [ Time Frame: Within first year from day of surgery ]New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse
- Revision surgeries [ Time Frame: 1 year ]All cause revisions
- Pedicle screw instrumentation accuracy [ Time Frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary ]Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on postoperative CTs that are clinically necessary for the management of the patient.
- Incidence of pseudoarthrosis (malunion) [ Time Frame: Within 1 year from surgery ]Failure of the operated spinal segment to fuse.
- Length of convalescence [ Time Frame: Within 1 year of surgery ]Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work
- Times of intra-operative stages [ Time Frame: Day of surgery ]instrumentation time per screw, total surgery time
- Ratio of executed vs. planned screws [ Time Frame: Day of surgery ]number of screws planned to be robotically inserted and manually inserted instead and cause.
- Quality of life assessment [ Time Frame: Each visit up to 1 year1 ]Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057744
|United States, Florida|
|Florida Hospital Celebration Health|
|Celebration, Florida, United States, 34747|
|Jacksonville, Florida, United States|
|University of Miami|
|Miami, Florida, United States, 33136|
|Central Florida Neurosurgery Institute|
|Orlando, Florida, United States, 32801|
|Southeastern Spine Center & Research Institute|
|Sarasota, Florida, United States, 34232|
|United States, Pennsylvania|
|The Rothman Institute|
|Abington, Pennsylvania, United States, 19001|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38116|
|United States, Virginia|
|Atlantic Brain & Spine|
|Fairfax, Virginia, United States, 22031|
|Virginia Spine Institute|
|Reston, Virginia, United States, 20191|
|Study Director:||Doron Dinstein, MD||Mazor Robotics, Ltd|