Clinical Trial of Minimally Invasive Robotic Spine Surgery

Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel; Procedure: free hand technique

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot assisted pedicle screw fixation; posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)	Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel; Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot; Other Names: (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Active Comparator: Free hand technique; using Free hand technique, posterior lumbar interbody fusion (No specific device)	Procedure: free hand technique; No specific device is necessary in the "free hand technique"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pedicle screw instrumentation accuracy	The location of pedicle screw is evaluated by postoperative CTs in a subset of patients	within 7 days after operation
Oswestry Disability Index	Health status	up to 5 year after operation, every year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion rates	This is assessed by postoperative computed tomography at 1 year after surgery	up to 5 year after operation
Operation duration	Intraoperative time	After operation
intraoperative blood loss	intraoperative blood loss	after operation
postoperative drainage	Total drainage after surgery	within 3 days after operation
amount of transfusion	Total transfusion during and after surgery	within 7 days after operation
time to ambulation	immediate postop to ambulation start	within 3 days after operation
Change of Oswestry Disability Index	Health status	up to 5 year after surgery, every year
Visual Analog Pain Scale	Pain status	up to 5 year after operation, every year
SF-36	Health status	up to 5 year after operation, every year
Radiographic adjacent level degeneration	Radiographic changes according to UCLA, vertebral body translation, motion change, segmental kyphosis or lordosis, disc height changes	up to 5 year after operation, every year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Ho-Joong Kim, MD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 19, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 29, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: Mazor_001