Overview

This trial is active, not recruiting.

Condition degenerative lumbar spinal stenosis
Treatments renaissance, mazor robotics ltd, caesare, israel, free hand technique
Sponsor Seoul National University Hospital
Start date December 2013
End date April 2014
Trial size 40 participants
Trial identifier NCT02121249, Mazor_001

Summary

The purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a matching cohort of control patients performed using conventional freehand technique.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
renaissance, mazor robotics ltd, caesare, israel (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
(Active Comparator)
using Free hand technique, posterior lumbar interbody fusion (No specific device)
free hand technique
No specific device is necessary in the "free hand technique"

Primary Outcomes

Measure
Pedicle screw instrumentation accuracy
time frame: within 7 days after operation

Secondary Outcomes

Measure
Fusion rates
time frame: up to 1 year after operation
Operation duration
time frame: After operation
intraoperative blood loss
time frame: after operation
postoperative drainage
time frame: within 3 days after operation
amount of transfusion
time frame: within 7 days after operation
time to ambulation
time frame: within 3 days after operation
Oswestry Disability Index
time frame: up to 1 year after surgery
Visual Analog Pain Scale
time frame: up to 1 year after operation

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

Inclusion Criteria: - Adult patients (age from 40 years to 85 years), undergoing short (below 3 consecutive vertebrae) lumbar or lumbosacral fixation surgery. - Primary surgery and revision surgery - Patient capable of complying with study requirements - Signed informed consent of patient or legal guardian Exclusion Criteria: - Infection or malignancy - Primary abnormalities of bones (e.g. osteogenesis imperfecta) - Primary muscle diseases, such as muscular dystrophy - Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma) - Spinal cord abnormalities with any neurologic symptoms or signs - Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia - Paraplegia - Patients requiring anterior release or instrumentation - 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. - Patient cannot follow study protocol, for any reason - Patient (or legal guardian, when applicable) cannot or will not sign informed consent

Additional Information

Official title Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
Principal investigator Ho-Joong Kim, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.