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Clinical Trial of Minimally Invasive Robotic Spine Surgery

Primary Purpose

Degenerative Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Renaissance, Mazor Robotics Ltd, Caesare, Israel
free hand technique
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot assisted pedicle screw fixation

Free hand technique

Arm Description

posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)

using Free hand technique, posterior lumbar interbody fusion (No specific device)

Outcomes

Primary Outcome Measures

Pedicle screw instrumentation accuracy
The location of pedicle screw is evaluated by postoperative CTs in a subset of patients
Oswestry Disability Index
Health status

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2014
Last Updated
March 29, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02121249
Brief Title
Clinical Trial of Minimally Invasive Robotic Spine Surgery
Official Title
Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot assisted pedicle screw fixation
Arm Type
Experimental
Arm Description
posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Arm Title
Free hand technique
Arm Type
Active Comparator
Arm Description
using Free hand technique, posterior lumbar interbody fusion (No specific device)
Intervention Type
Device
Intervention Name(s)
Renaissance, Mazor Robotics Ltd, Caesare, Israel
Other Intervention Name(s)
(Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Intervention Description
Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
Intervention Type
Procedure
Intervention Name(s)
free hand technique
Intervention Description
No specific device is necessary in the "free hand technique"
Primary Outcome Measure Information:
Title
Pedicle screw instrumentation accuracy
Description
The location of pedicle screw is evaluated by postoperative CTs in a subset of patients
Time Frame
within 7 days after operation
Title
Oswestry Disability Index
Description
Health status
Time Frame
up to 5 year after operation, every year
Secondary Outcome Measure Information:
Title
Fusion rates
Description
This is assessed by postoperative computed tomography at 1 year after surgery
Time Frame
up to 5 year after operation
Title
Operation duration
Description
Intraoperative time
Time Frame
After operation
Title
intraoperative blood loss
Description
intraoperative blood loss
Time Frame
after operation
Title
postoperative drainage
Description
Total drainage after surgery
Time Frame
within 3 days after operation
Title
amount of transfusion
Description
Total transfusion during and after surgery
Time Frame
within 7 days after operation
Title
time to ambulation
Description
immediate postop to ambulation start
Time Frame
within 3 days after operation
Title
Change of Oswestry Disability Index
Description
Health status
Time Frame
up to 5 year after surgery, every year
Title
Visual Analog Pain Scale
Description
Pain status
Time Frame
up to 5 year after operation, every year
Title
SF-36
Description
Health status
Time Frame
up to 5 year after operation, every year
Title
Radiographic adjacent level degeneration
Description
Radiographic changes according to UCLA, vertebral body translation, motion change, segmental kyphosis or lordosis, disc height changes
Time Frame
up to 5 year after operation, every year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Joong Kim, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Clinical Trial of Minimally Invasive Robotic Spine Surgery

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