MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries

• Conditions: Degenerative Spine Disease; Spondylolisthesis; Spondylosis

• Registration Number: NCT02057744
• Lead Sponsor: Mazor Robotics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Study Start: 2014-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Revision surgeries	1 year	All cause revisions
Intra-operative exposure to x-ray radiation	Day of surgery	Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.
Surgical complications	Within first year from day of surgery	New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse

Secondary Outcome Measures

Name	Time	Method
Incidence of pseudoarthrosis (malunion)	Within 1 year from surgery	Failure of the operated spinal segment to fuse.
Length of convalescence	Within 1 year of surgery	Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work
Ratio of executed vs. planned screws	Day of surgery	number of screws planned to be robotically inserted and manually inserted instead and cause.
Quality of life assessment	Each visit up to 1 year1	Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)
Pedicle screw instrumentation accuracy	Within 1 year of surgery, if indicated by surgeon and clinically necessary	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.
Times of intra-operative stages	Day of surgery	instrumentation time per screw, total surgery time

Trial Locations

Locations (9)

Baptist Health; 🇺🇸 Jacksonville, Florida, United States

The Rothman Institute; 🇺🇸 Abington, Pennsylvania, United States

Florida Hospital Celebration Health; 🇺🇸 Celebration, Florida, United States

Tabor Orthopedics; 🇺🇸 Memphis, Tennessee, United States

Atlantic Brain & Spine; 🇺🇸 Fairfax, Virginia, United States

Southeastern Spine Center & Research Institute; 🇺🇸 Sarasota, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Virginia Spine Institute; 🇺🇸 Reston, Virginia, United States

Central Florida Neurosurgery Institute; 🇺🇸 Orlando, Florida, United States