Clinical Trial of Minimally Invasive Robotic Spine Surgery

Study Overview
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Brief Summary
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The purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a matching cohort of control patients performed using conventional freehand technique.

Official Title
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Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries

Conditions
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Degenerative Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel
* Procedure: free hand technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age from 40 years to 85 years), undergoing short (below 3 consecutive vertebrae) lumbar or lumbosacral fixation surgery. Primary surgery and revision surgery Patient capable of complying with study requirements Signed informed consent of patient or legal guardian Exclusion Criteria: 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, neurofibroma) Spinal cord abnormalities with any neurologic symptoms or signs Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia Paraplegia 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 (or legal guardian, when applicable) cannot or will not sign informed consent

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot assisted pedicle screw fixation<br>posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel) | Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel<br>* Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot<br>* Other names: (Renaissance, Mazor Robotics Ltd, Caesare, Israel);|
| Active Comparator: Free hand technique<br>using Free hand technique, posterior lumbar interbody fusion (No specific device) | Procedure: free hand technique<br>* No specific device is necessary in the free hand technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pedicle screw instrumentation accuracy | The location of pedicle screw is evaluated by postoperative CTs in a subset of patients | within 7 days after operation | 
| Oswestry Disability Index | Health status | up to 5 year after operation, every year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rates | This is assessed by postoperative computed tomography at 1 year after surgery | up to 5 year after operation | 
| Operation duration | Intraoperative time | After operation | 
| intraoperative blood loss | intraoperative blood loss | after operation | 
| postoperative drainage | Total drainage after surgery | within 3 days after operation | 
| amount of transfusion | Total transfusion during and after surgery | within 7 days after operation | 
| time to ambulation | immediate postop to ambulation start | within 3 days after operation | 
| Change of Oswestry Disability Index | Health status | up to 5 year after surgery, every year | 
| Visual Analog Pain Scale | Pain status | up to 5 year after operation, every year | 
| SF-36 | Health status | up to 5 year after operation, every year | 
| Radiographic adjacent level degeneration | Radiographic changes according to UCLA, vertebral body translation, motion change, segmental kyphosis or lordosis, disc height changes | up to 5 year after operation, every year |