Degenerative Spine DiseaseNCT02057744
MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
An observational study of Degenerative Spine Disease and Spondylolisthesis, run by Mazor Robotics at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Degenerative Spine Disease, Spondylolisthesis, Spondylosis
- How many people
- 600 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2014to Jan 2020
- Phase
- Observational
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive spinal fixation sugery.
Who may be able to join
- Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/MIS spinal fixation surgery.
- May include surgeries involving iliac screws, although these screws will not be included in the data analysis.
- Primary fusion surgery
- Patient capable of complying with study requirements
- Signed informed consent by patient
Who cannot join
- Pregnancy
- Revision surgery (prior laminectomy or discectomy is not excluded).
- 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, spina bifida or neurofibroma)
Show all 14Show fewer
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- Paraplegia
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- 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 cannot or will not sign informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
The Rothman Institute
Abington, Pennsylvania, 19001
Florida Hospital Celebration Health
Celebration, Florida, 34747
Atlantic Brain & Spine
Fairfax, Virginia, 22031
Baptist Health
Jacksonville, Florida
Tabor Orthopedics
Memphis, Tennessee, 38116
University of Miami
Miami, Florida, 33136
Central Florida Neurosurgery Institute
Orlando, Florida, 32801
Virginia Spine Institute
Reston, Virginia, 20191
Southeastern Spine Center & Research Institute
Sarasota, Florida, 34232
About this study
Official title: Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
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.
- Conditions
- Degenerative Spine Disease, Spondylolisthesis, Spondylosis
- Keywords
- Robotic-guided surgery, Minimally invasive spinal surgery, Spinal fusion, Pedicle screws
- Medical subject headings
- Spondylolisthesis, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-guided | Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive robotic-guided spinal fixation surgery. | |
| Freehand image-guided | Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive image-guided freehand or navigated spinal fixation surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative exposure to x-ray radiation
Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.
Measured: Day of surgery
Surgical complications
New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse
Measured: Within first year from day of surgery
Revision surgeries
All cause revisions
Measured: 1 year
Secondary outcomes (6)
Pedicle screw instrumentation accuracy
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.
Measured: Within 1 year of surgery, if indicated by surgeon and clinically necessary
Incidence of pseudoarthrosis (malunion)
Failure of the operated spinal segment to fuse.
Measured: Within 1 year from surgery
Length of convalescence
Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work
Measured: Within 1 year of surgery
Times of intra-operative stages
instrumentation time per screw, total surgery time
Measured: Day of surgery
Ratio of executed vs. planned screws
number of screws planned to be robotically inserted and manually inserted instead and cause.
Measured: Day of surgery
Quality of life assessment
Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)
Measured: Each visit up to 1 year1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degenerative Spine DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mazor Robotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doron Dinstein, MD, Study director, Mazor Robotics, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057744
- Sponsor's protocol ID
- CLN110
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2014
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab.
PubMed 21079498Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.
PubMed 21384205Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.
PubMed 22975723
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
- ClinicalTrials.gov ID
- NCT02057744
- Acronym / sponsor ID
- CLN110
- Conditions
- Degenerative Spine Disease, Spondylolisthesis, Spondylosis
- Keywords
- Robotic-guided surgery, Minimally invasive spinal surgery, Spinal fusion, Pedicle screws
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mazor RoboticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 7 Feb 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-guided | – | –Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive robotic-guided spinal fixation surgery. |
| Freehand image-guided | – | –Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive image-guided freehand or navigated spinal fixation surgery. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (21 years or older) undergoing short (4 or less consecutive vertebrae) thoracic, lumbar or lumbosacral percutaneous/minimally invasive spinal fixation sugery.
Key inclusion criteria (5 listed)
- Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/MIS spinal fixation surgery.
- May include surgeries involving iliac screws, although these screws will not be included in the data analysis.
- Primary fusion surgery
- Patient capable of complying with study requirements
- Signed informed consent by patient
Key exclusion criteria (14 listed)
- Pregnancy
- Revision surgery (prior laminectomy or discectomy is not excluded).
- Infection or malignancy
- Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- Primary muscle diseases, such as muscular dystrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intra-operative exposure to x-ray radiation
Time frame: 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
Time frame: 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
Revision surgeries
Time frame: 1 year
All cause revisions
6 secondary outcomes
Pedicle screw instrumentation accuracy
Time frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary
Incidence of pseudoarthrosis (malunion)
Time frame: Within 1 year from surgery
Length of convalescence
Time frame: Within 1 year of surgery
Times of intra-operative stages
Time frame: Day of surgery
Ratio of executed vs. planned screws
Time frame: Day of surgery
Quality of life assessment
Time frame: Each visit up to 1 year1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 21079498Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab.
- Background: PubMed 21384205Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.
- Background: PubMed 22975723Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.
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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.
Doron Dinstein, MD study director
Mazor Robotics, Ltd
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Spine Disease and Spondylolisthesis, run by Mazor Robotics at 9 sites in United States.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Results are not available in the source record.
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?
Intra-operative exposure to x-ray radiation (time frame: Day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02057744, which also lists 3 linked publications.
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 20 Aug 2019.