ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity

Withdrawn

• Conditions: Spondylosis; Spinal Deformity; Kyphoscoliosis; Scoliosis; Kyphosis

• Registration Number: NCT02058238
• Lead Sponsor: Mazor Robotics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-10
• Study Start: 2014-10-03
• Primary Completion: 2015-03-01
• Study Completion: 2015-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraoperative radiation exposure	Day of operation	as measured by the C-arm, normalized per screw
Revision surgeries	2 years	All cause revisions, including medical and surgical complications.
Incidence of surgical complications	1 year	New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss

Secondary Outcome Measures

Name	Time	Method
Deformity correction as measured on plain radiographs	Within 2 years from surgery	Parameters of sagittal and coronal balance
Ratio of executed vs. planned screws	Day of surgery	Number of screws planned to be robotically inserted but manually inserted instead, and cause.
Times of intra-operative stages	Day of surgery	Instrumentation time per screw, total surgery time
Fusion rate/pseudoarthrosis	Within one year post-surgery	Fusion/pseudoarthrosis as measured within one year of surgery
Clinical outcome measures assessed using health-related quality of life questionnaires	up to 10 years post-operative	Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L)
Implant Failure	Within 1 year post-surgery	The implant failure rate as measured within one year post-surgery
Neuromonitoring events	Day of surgery	The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw.
Number of Abandoned Screws	Day of surgery	Number of screws intended to be instrumented with the robot and abandoned for cause.
Pedicle screw instrumentation accuracy	Within 1 year of surgery	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.
Length of convalescence	Within 2 years of surgery	Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work
Number of screws instrumented freehand	Day of surgery	Number of screws planned to be instrumented robotically and instrumented freehand instead.
Clinical performance of instrumentation technique	Day of surgery	Implant instrumentation time, length of surgery

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States