ScoliosisNCT02058238
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
An observational study of Scoliosis and Kyphosis, run by Mazor Robotics at 1 site in United States.
Trial summary
To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Scoliosis, Kyphosis, Kyphoscoliosis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2014to 1 Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age over 21 years) undergoing long (5 or more consecutive vertebrae) open or minimally invasive instrumentation, correction and fusion sugery in the thoracic, lumbar or sacral spine who have been found to have kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
Who may be able to join
- Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
- Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
- Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
- Patient capable of complying with study requirements
- Signed informed consent by patient
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, spina bifida, or neurofibroma)
- Spinal cord abnormalities with any neurologic symptoms or signs
- Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
Show all 12Show fewer
- Paraplegia
- Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
- 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.
- Pregnancy
- Patient cannot follow study protocol, for any reason
- Patient cannot or will not sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity
To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.
- Conditions
- Scoliosis, Kyphosis, Kyphoscoliosis, Spinal Deformity, Spondylosis
- Keywords
- Robotic-guided spinal fusions, Scoliosis, Kyphoscoliosis, Spinal deformity, Spondylosis
- Medical subject headings
- Scoliosis, Kyphosis, 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 |
|---|---|---|
| Arm 1: Robotic-guided, Open approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. | |
| Arm 2: control-arm - non-robotic, open approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. | |
| Arm 3: robotic-guided, MIS approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. | |
| Arm 4: control-arm - freehand, MIS approach | Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical complications
New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss
Measured: 1 year
Intraoperative radiation exposure
as measured by the C-arm, normalized per screw
Measured: Day of operation
Revision surgeries
All cause revisions, including medical and surgical complications.
Measured: 2 years
Secondary outcomes (12)
Deformity correction as measured on plain radiographs
Parameters of sagittal and coronal balance
Measured: Within 2 years from surgery
Clinical outcome measures assessed using health-related quality of life questionnaires
Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L)
Measured: up to 10 years post-operative
Pedicle screw instrumentation accuracy
Accuracy will be quantified in millimeters and scored using the Gertzbein Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient.
Measured: Within 1 year of 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 2 years of surgery
Ratio of executed vs. planned screws
Number of screws planned to be robotically inserted but manually inserted instead, and cause.
Measured: Day of surgery
Times of intra-operative stages
Instrumentation time per screw, total surgery time
Measured: Day of surgery
Implant Failure
The implant failure rate as measured within one year post-surgery
Measured: Within 1 year post-surgery
Number of Abandoned Screws
Number of screws intended to be instrumented with the robot and abandoned for cause.
Measured: Day of surgery
Number of screws instrumented freehand
Number of screws planned to be instrumented robotically and instrumented freehand instead.
Measured: Day of surgery
Clinical performance of instrumentation technique
Implant instrumentation time, length of surgery
Measured: Day of surgery
Fusion rate/pseudoarthrosis
Fusion/pseudoarthrosis as measured within one year of surgery
Measured: Within one year post-surgery
Neuromonitoring events
The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study start3 Oct 2014
- Primary completion1 Mar 2015
- Study completion1 Mar 2015
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazor Robotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doron Dinstein, MD, Study director, Mazor Robotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058238
- Sponsor's protocol ID
- CLN105
- Status last verified
- Sep 2020
- First submitted
- 6 Feb 2014
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu X, Ohnmeiss DD, Lieberman IH. Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16.
PubMed 23584231Devito 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 21079498
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADDRESS - Multicenter, Partially-randomized Controlled Trial of Adult Deformity Robotic vs. Freehand Surgery to Correct Adult Spine Deformity
- ClinicalTrials.gov ID
- NCT02058238
- Acronym / sponsor ID
- CLN105
- Conditions
- Scoliosis, Kyphosis, Kyphoscoliosis, Spinal Deformity, Spondylosis
- Keywords
- Robotic-guided spinal fusions, Scoliosis, Kyphoscoliosis, Spinal deformity, Spondylosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mazor RoboticsIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2014 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 10 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 (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Robotic-guided, Open approach | – | –Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. |
| Arm 2: control-arm - non-robotic, open approach | – | –Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. |
| Arm 3: robotic-guided, MIS approach | – | –Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. |
| Arm 4: control-arm - freehand, MIS approach | – | –Adult patients (age> 21 years) undergoing long (>4 consecutive vertebrae) open instrumentation, correction and fusion surgery in the thoracic, lumbar or sacral spine for a kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age over 21 years) undergoing long (5 or more consecutive vertebrae) open or minimally invasive instrumentation, correction and fusion sugery in the thoracic, lumbar or sacral spine who have been found to have kypho/scoliotic curve, sagittal or coronal imbalance or a combination of these.
Key inclusion criteria (5 listed)
- Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum.
- Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis.
- Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty).
- Patient capable of complying with study requirements
- Signed informed consent by patient
Key exclusion criteria (12 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, spina bifida, or 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.
Primary outcome
Incidence of surgical complications
Time frame: 1 year
New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss
Intraoperative radiation exposure
Time frame: Day of operation
as measured by the C-arm, normalized per screw
Revision surgeries
Time frame: 2 years
All cause revisions, including medical and surgical complications.
12 secondary outcomes
Deformity correction as measured on plain radiographs
Time frame: Within 2 years from surgery
Clinical outcome measures assessed using health-related quality of life questionnaires
Time frame: up to 10 years post-operative
Pedicle screw instrumentation accuracy
Time frame: Within 1 year of surgery
Length of convalescence
Time frame: Within 2 years of surgery
Ratio of executed vs. planned screws
Time frame: Day of surgery
Times of intra-operative stages
Time frame: Day of surgery
Implant Failure
Time frame: Within 1 year post-surgery
Number of Abandoned Screws
Time frame: Day of surgery
Number of screws instrumented freehand
Time frame: Day of surgery
Clinical performance of instrumentation technique
Time frame: Day of surgery
Fusion rate/pseudoarthrosis
Time frame: Within one year post-surgery
Neuromonitoring events
Time frame: Day of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Background: PubMed 23584231Hu X, Ohnmeiss DD, Lieberman IH. Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients. Eur Spine J. 2013 Dec;22(12):2845-9. doi: 10.1007/s00586-013-2780-y. Epub 2013 Apr 16.
- 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Kyphosis, run by Mazor Robotics at 1 site 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 12 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: withdrawn, as of the sponsor's last update on 5 Oct 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of surgical complications (time frame: 1 year). 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 NCT02058238, which also lists 2 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 5 Oct 2020.