IS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.
Degenerative Disc Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries|
- Intra-operative exposure to x-ray radiation [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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: 2 years ] [ Designated as safety issue: No ]All cause revisions
- Pedicle screw instrumentation accuracy [ Time Frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary ] [ Designated as safety issue: No ]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 10 years from surgery ] [ Designated as safety issue: No ]Failure of the operated spinal segment to fuse.
- Length of convalescence [ Time Frame: Within 2 years of surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]instrumentation time per screw, total surgery time
- Ratio of executed vs. planned screws [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]number of screws planned to be robotically inserted and manually inserted instead and cause.
- Quality of life assessment [ Time Frame: Each visit up to 10 years ] [ Designated as safety issue: No ]Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||January 2027|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02057744
|Contact: Doron Dinstein, MD||(800) 80 - MAZORfirstname.lastname@example.org|
|United States, Florida|
|Florida Hospital Celebration Health||Not yet recruiting|
|Celebration, Florida, United States|
|Contact: Faissal Zahrawi, MD 407-764-4270 SPINESRG@AOL.COM|
|Principal Investigator: Faissal Zahrawi, MD|
|Baptist Health||Not yet recruiting|
|Jacksonville, Florida, United States|
|Contact: Barbara P Hurlbert 904-388-6518 email@example.com|
|Principal Investigator: Andrew F Cannestra, MD, PhD|
|United States, Virginia|
|Virginia Spine Institute||Not yet recruiting|
|Reston, Virginia, United States|
|Contact: Anne Copay, PhD 703-709-1114 ext 144 firstname.lastname@example.org|
|Principal Investigator: Christopher R Good, MD|
|Apollo Hospitals||Not yet recruiting|
|Chennai, Tamil Nadu, India|
|Contact: Vamsi K Varma, MD +91 44 2829 0200 email@example.com|
|Principal Investigator: Sajan K Hegde, MD|
|Study Director:||Doron Dinstein, MD||Mazor Robotics, Ltd|