MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02057744|
Recruitment Status : Unknown
Verified August 2019 by Mazor Robotics.
Recruitment status was: Active, not recruiting
First Posted : February 7, 2014
Last Update Posted : August 20, 2019
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/MIS spinal fixation surgery.
- May include surgeries involving iliac screws, although these screws will not be included in the data analysis.
- Primary fusion surgery
- Patient capable of complying with study requirements
- Signed informed consent by patient
- Revision surgery (prior laminectomy or discectomy is not excluded).
- Infection or malignancy
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Primary muscle diseases, such as muscular dystrophy
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma)
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- Patients requiring anterior release or instrumentation
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
- Patient cannot follow study protocol, for any reason
- Patient cannot or will not sign informed consent
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|
|Responsible Party:||Mazor Robotics|
|Other Study ID Numbers:||
|First Posted:||February 7, 2014 Key Record Dates|
|Last Update Posted:||August 20, 2019|
|Last Verified:||August 2019|
Minimally invasive spinal surgery