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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02058238
Other study ID # CLN105
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 3, 2014
Est. completion date March 1, 2015

Study information

Verified date September 2020
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 (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 1, 2015
Est. primary completion date March 1, 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

1. Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.

2. Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.

3. Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).

4. Patient capable of complying with study requirements

5. Signed informed consent by patient

Exclusion Criteria:

1. Infection or malignancy

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

3. Primary muscle diseases, such as muscular dystrophy

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

5. Spinal cord abnormalities with any neurologic symptoms or signs

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

7. Paraplegia

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

9. 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.

10. Pregnancy

11. Patient cannot follow study protocol, for any reason

12. Patient cannot or will not sign informed consent

Study Design


Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
Mazor Robotics

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of surgical complications New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss 1 year
Primary Intraoperative radiation exposure as measured by the C-arm, normalized per screw Day of operation
Primary Revision surgeries All cause revisions, including medical and surgical complications. 2 years
Secondary Deformity correction as measured on plain radiographs Parameters of sagittal and coronal balance Within 2 years from surgery
Secondary Clinical outcome measures assessed using health-related quality of life questionnaires Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L) up to 10 years post-operative
Secondary Pedicle screw instrumentation accuracy Accuracy will be quantified in millimeters and scored using the Gertzbein Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient. Within 1 year of 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 2 years of surgery
Secondary Ratio of executed vs. planned screws Number of screws planned to be robotically inserted but manually inserted instead, and cause. Day of surgery
Secondary Times of intra-operative stages Instrumentation time per screw, total surgery time Day of surgery
Secondary Implant Failure The implant failure rate as measured within one year post-surgery Within 1 year post-surgery
Secondary Number of Abandoned Screws Number of screws intended to be instrumented with the robot and abandoned for cause. Day of surgery
Secondary Number of screws instrumented freehand Number of screws planned to be instrumented robotically and instrumented freehand instead. Day of surgery
Secondary Clinical performance of instrumentation technique Implant instrumentation time, length of surgery Day of surgery
Secondary Fusion rate/pseudoarthrosis Fusion/pseudoarthrosis as measured within one year of surgery Within one year post-surgery
Secondary Neuromonitoring events The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw. Day of surgery
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