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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02057744
Other study ID # CLN110
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2014
Est. completion date January 2020

Study information

Verified date August 2019
Source Mazor Robotics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years to 99 Years
Eligibility 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

Study Design


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Mazor Robotics

Country where clinical trial is conducted

United States, 

References & Publications (3)

Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stüer 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. Erratum in: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D]. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intra-operative exposure to x-ray radiation Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room. Day of surgery
Primary Surgical complications New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse Within first year from day of surgery
Primary Revision surgeries All cause revisions 1 year
Secondary Pedicle screw instrumentation accuracy Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on postoperative CTs that are clinically necessary for the management of the patient. Within 1 year of surgery, if indicated by surgeon and clinically necessary
Secondary Incidence of pseudoarthrosis (malunion) Failure of the operated spinal segment to fuse. Within 1 year from surgery
Secondary Length of convalescence Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work Within 1 year of surgery
Secondary Times of intra-operative stages instrumentation time per screw, total surgery time Day of surgery
Secondary Ratio of executed vs. planned screws number of screws planned to be robotically inserted and manually inserted instead and cause. Day of surgery
Secondary Quality of life assessment Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L) Each visit up to 1 year1
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