MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

Status unconfirmed

Conditions studied: Degenerative Spine Disease, Spondylolisthesis, Spondylosis

In brief

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.

Key facts

Study ID

NCT02057744

Run by

Mazor Robotics

People needed

600

Starts

2014-10-01

Expected to finish

2020-01-01

Last updated by the study team

2019-08-20

Who can join

Age: 21 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Florida Hospital Celebration Health — Celebration, Florida, United States
• Baptist Health — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Central Florida Neurosurgery Institute — Orlando, Florida, United States
• Southeastern Spine Center & Research Institute — Sarasota, Florida, United States
• The Rothman Institute — Abington, Pennsylvania, United States
• Tabor Orthopedics — Memphis, Tennessee, United States
• Atlantic Brain & Spine — Fairfax, Virginia, United States
• Virginia Spine Institute — Reston, Virginia, United States

Full record on ClinicalTrials.gov

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