MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries



Status:Active, not recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 99
Updated:3/10/2019
Start Date:October 2014
End Date:March 2032

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


Inclusion Criteria:

1. Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae)
lumbar or lumbosacral percutaneous/MIS spinal fixation surgery.

2. May include surgeries involving iliac screws, although these screws will not be
included in the data analysis.

3. Primary fusion surgery

4. Patient capable of complying with study requirements

5. Signed informed consent by patient

Exclusion Criteria:

1. Pregnancy

2. Revision surgery (prior laminectomy or discectomy is not excluded).

3. Infection or malignancy

4. Primary abnormalities of bones (e.g. osteogenesis imperfecta)

5. Primary muscle diseases, such as muscular dystrophy

6. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral
palsy, spina bifida or neurofibroma)

7. Spinal cord abnormalities with any neurologic symptoms or signs

8. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia

9. Paraplegia

10. Patients who have participated in a research study involving an investigational
product in the 12 weeks prior to surgery

11. Patients requiring anterior release or instrumentation

12. 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.

13. Patient cannot follow study protocol, for any reason

14. Patient cannot or will not sign informed consent
We found this trial at
9
sites
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Michael Y Wang, MD
Phone: 305-243-2361
University of Miami A private research university with more than 15,000 students from around the...
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Celebration, Florida 34747
Principal Investigator: Faissal Zahrawi, MD
Phone: 407-566-4411
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Abington, Pennsylvania 19001
Principal Investigator: Victor Hsu, MD
Phone: 215-454-2247
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Fairfax, Virginia 22031
Principal Investigator: Jae Y Lim, MD
Phone: 703-876-4270
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Jacksonville, Florida
Principal Investigator: Andrew F Cannestra, MD, PhD
Phone: 904-202-7998
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Memphis, Tennessee 38116
Principal Investigator: Samuel R Schroerlucke, MD
Phone: 901-767-8662
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801 North Orange Avenue
Orlando, Florida 32801
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Orlando, FL
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Reston, Virginia 20190
Principal Investigator: Christopher R Good, MD
Phone: 703-766-5405
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Sarasota, Florida 34342
Principal Investigator: Thomas M Sweeney, MD
Phone: 901-371-9773
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Sarasota, FL
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