Degenerative Lumbar Spinal StenosisNCT02121249
Clinical Trial of Minimally Invasive Robotic Spine Surgery
A study testing Renaissance, Mazor Robotics Ltd, Caesare, Israel and free hand technique in people with Degenerative Lumbar Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- Renaissance, Mazor Robotics Ltd, Caesare, Israel and free hand technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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.
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- Renaissance, Mazor Robotics Ltd, Caesare, Israel, free hand technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renaissance, Mazor Robotics Ltd, Caesare, IsraelDevice
Also called (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
free hand techniqueProcedure or surgery
No specific device is necessary in the "free hand technique"
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted pedicle screw fixation | Experimental | posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel) Receives: Device: Renaissance, Mazor Robotics Ltd, Caesare, Israel |
| Free hand technique | Active comparator | using Free hand technique, posterior lumbar interbody fusion (No specific device) Receives: Procedure: free hand technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedicle screw instrumentation accuracy
The location of pedicle screw is evaluated by postoperative CTs in a subset of patients
Measured: within 7 days after operation
Oswestry Disability Index
Health status
Measured: up to 5 year after operation, every year
Secondary outcomes (10)
Fusion rates
This is assessed by postoperative computed tomography at 1 year after surgery
Measured: up to 5 year after operation
Operation duration
Intraoperative time
Measured: After operation
intraoperative blood loss
intraoperative blood loss
Measured: after operation
postoperative drainage
Total drainage after surgery
Measured: within 3 days after operation
amount of transfusion
Total transfusion during and after surgery
Measured: within 7 days after operation
time to ambulation
immediate postop to ambulation start
Measured: within 3 days after operation
Change of Oswestry Disability Index
Health status
Measured: up to 5 year after surgery, every year
Visual Analog Pain Scale
Pain status
Measured: up to 5 year after operation, every year
SF-36
Health status
Measured: 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
Measured: up to 5 year after operation, every year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin S. Yeom, Seoul National University Hospital
- Investigators
- Ho-Joong Kim, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121249
- Sponsor's protocol ID
- Mazor_001
- Status last verified
- Mar 2020
- First submitted
- 15 Apr 2014
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
- ClinicalTrials.gov ID
- NCT02121249
- Acronym / sponsor ID
- Mazor_001
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot assisted pedicle screw fixation | Experimental | Device: Renaissance, Mazor Robotics Ltd, Caesare, Israelposterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel) |
| Free hand technique | Active comparator | Procedure: free hand techniqueusing Free hand technique, posterior lumbar interbody fusion (No specific device) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renaissance, Mazor Robotics Ltd, Caesare, IsraelAlso: (Renaissance, Mazor Robotics Ltd, Caesare, Israel)Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot | Device | Robot assisted pedicle screw fixation |
| free hand techniqueNo specific device is necessary in the "free hand technique" | Procedure or surgery | Free hand technique |
Primary outcome
Pedicle screw instrumentation accuracy
Time frame: within 7 days after operation
The location of pedicle screw is evaluated by postoperative CTs in a subset of patients
Oswestry Disability Index
Time frame: up to 5 year after operation, every year
Health status
10 secondary outcomes
Fusion rates
Time frame: up to 5 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
Change of Oswestry Disability Index
Time frame: up to 5 year after surgery, every year
Visual Analog Pain Scale
Time frame: up to 5 year after operation, every year
SF-36
Time frame: up to 5 year after operation, every year
Radiographic adjacent level degeneration
Time frame: up to 5 year after operation, every year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Joong Kim, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renaissance, Mazor Robotics Ltd, Caesare, Israel and free hand technique in people with Degenerative Lumbar Spinal Stenosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedicle screw instrumentation accuracy (time frame: within 7 days after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.