MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

Study Overview
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Brief Summary
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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.

Official Title
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Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries

Conditions
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Degenerative Spine Disease, Spondylolisthesis, Spondylosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnancy 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 Paraplegia 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic-guided<br>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. | |
| Freehand image-guided<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative exposure to x-ray radiation | Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room. | Day of surgery | 
| Surgical complications | New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse | Within first year from day of surgery | 
| Revision surgeries | All cause revisions | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pedicle screw instrumentation accuracy | 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. | Within 1 year of surgery, if indicated by surgeon and clinically necessary | 
| Incidence of pseudoarthrosis (malunion) | Failure of the operated spinal segment to fuse. | Within 1 year from surgery | 
| Length of convalescence | Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work | Within 1 year of surgery | 
| Times of intra-operative stages | instrumentation time per screw, total surgery time | Day of surgery | 
| Ratio of executed vs. planned screws | number of screws planned to be robotically inserted and manually inserted instead and cause. | Day of surgery | 
| Quality of life assessment | Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L) | Each visit up to 1 year1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic-guided surgery, Minimally invasive spinal surgery, Spinal fusion, Pedicle screws