Clinical Trial of Minimally Invasive Robotic Spine Surgery

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

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.

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