Clinical trial NCT02057744: MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
Official title: Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Spine Disease
Spondylolisthesis
Spondylosis
Keywords: Robotic-guided surgery
Minimally invasive spinal surgery
Spinal fusion
Pedicle screws
Lead sponsor: Mazor Robotics
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive spinal fixation sugery.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intra-operative exposure to x-ray radiation
timeFrame: Day of surgery
measure: Surgical complications
timeFrame: Within first year from day of surgery
measure: Revision surgeries
timeFrame: 1 year
Secondary outcomes:
measure: Pedicle screw instrumentation accuracy
timeFrame: Within 1 year of surgery, if indicated by surgeon and clinically necessary
measure: Incidence of pseudoarthrosis (malunion)
timeFrame: Within 1 year from surgery
measure: Length of convalescence
timeFrame: Within 1 year of surgery
measure: Times of intra-operative stages
timeFrame: Day of surgery
measure: Ratio of executed vs. planned screws
timeFrame: Day of surgery
measure: Quality of life assessment
timeFrame: Each visit up to 1 year1
Other outcomes:
Locations:
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Central Florida Neurosurgery Institute
state: Florida
city: Sarasota
country: United States
facility: Southeastern Spine Center & Research Institute
state: Florida
city: Abington
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Memphis
country: United States
facility: Tabor Orthopedics
state: Tennessee
city: Fairfax
country: United States
facility: Atlantic Brain & Spine
state: Virginia
city: Reston
country: United States
facility: Virginia Spine Institute
state: Virginia
Study officials:
affiliation: Mazor Robotics, Ltd
name: Doron Dinstein, MD
role: STUDY_DIRECTOR
References:
citation: Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab.
citation: Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.
citation: Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.