MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
|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)
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|