Degenerative Disc DiseaseAQrateNCT02558621
New Robotic Assistance System for Spinal Fusion Surgery
A study testing AQrate Robotic Assistance System in people with Degenerative Disc Disease and Spinal Stenosis, run by KB Medical SA at 2 sites in Switzerland.
Trial summary
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- What is being tested?
- AQrate Robotic Assistance System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Sep 2015to May 2016
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age from 18 years to 85 years) scheduled for spinal fusion surgery,
- Primary spinal surgery (It is the first surgery on this patient's spine)
- Patient is capable of complying with study requirements, and
- Patient is willing to provide a signed informed consent.
Who cannot join
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
- Infection or malignancy
- Previous spondylodesis
- Previous spinal surgical procedures
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma)
Show all 13Show fewer
- Spinal cord abnormalities with any neurologic symptoms or signs
- Paraplegia
- 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
- Patients in emergency situation, are not legally competent, cannot understand the situation,
- Pediatric patients
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Clinic Genolier
Genolier, Canton of Vaud, 1272
Hôpital du Valais
Sion, Valais, 1951
About this study
Official title: Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
Read the detailed description
Based on the literature review of similar devices and on the pre-clinical tests performed with the AQrate System on bench and cadavers, the study is build around the following hypothesis:
- The design and principle of operation of the AQrate System permits a correct integration in the surgical procedure flow thus enabling the surgeon to benefit from its advantages while not generating any additional operational difficulties
- The stability and ease of use of the device will permit the surgeon to achieve any planned spinal fusion without requiring additional assistance from the medical staff compared to a conventional spinal fusion surgery.
- A spinal fusion surgery procedure that is performed with the use of the AQrate System is similar to conventional spinal fusion surgery. If correctly used, no additional adverse event should be observed.
- The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle screws placed should be reduced
- The precision of placement of pedicle screw should not be adversely affected by the use of the system compared to conventional spinal surgery.
- Being tested
- AQrate Robotic Assistance System
- Keywords
- Robotic Spinal Fusion Surgery
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQrate Robotic Assistance SystemDevice
Robotic guidance during spinal fusion surgery
| Study group | Role | What they receive |
|---|---|---|
| Device: AQrate Robotic Assistance System | Experimental | Precise positioning of surgical instruments and spinal implants during general spinal surgery. Receives: Device: AQrate Robotic Assistance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical acceptance of the performance of the AQrate Robotic Assistance System.
The acceptance of the performance of the AQrate System will be measured by scale given to total of 8 questions.
Measured: Day of surgery
Secondary outcomes (2)
Intraoperative exposure to radiation
Exposure of radiation in seconds from O-arm or other imaging system used during surgery
Measured: Day of surgery
Accuracy of spinal screws placed
The assessment of the accuracy of pedicle screw will be evaluated post operatively on the CT scan, at discharge with the Gertzbein grading scale and copared to a freehand technique
Measured: Within one month of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- KB Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Denis Patet, MD, Principal investigator, Clinic Genolier, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558621
- Sponsor's protocol ID
- AQrate01/2015
- Acronym
- AQrate
- Status last verified
- May 2016
- First submitted
- 23 Sep 2015
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kostrzewski S, Duff JM, Baur C, Olszewski M. Robotic system for cervical spine surgery. Int J Med Robot. 2012 Jun;8(2):184-90. doi: 10.1002/rcs.446. Epub 2011 Dec 21.
PubMed 22190547
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT02558621
- Acronym / sponsor ID
- AQrate / AQrate01/2015
- Keywords
- Robotic Spinal Fusion Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- KB Medical SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Sep 2015 (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 main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
Detailed description
Based on the literature review of similar devices and on the pre-clinical tests performed with the AQrate System on bench and cadavers, the study is build around the following hypothesis:
- The design and principle of operation of the AQrate System permits a correct integration in the surgical procedure flow thus enabling the surgeon to benefit from its advantages while not generating any additional operational difficulties
- The stability and ease of use of the device will permit the surgeon to achieve any planned spinal fusion without requiring additional assistance from the medical staff compared to a conventional spinal fusion surgery.
- A spinal fusion surgery procedure that is performed with the use of the AQrate System is similar to conventional spinal fusion surgery. If correctly used, no additional adverse event should be observed.
- The exposure to x-ray should decrease as the need of intraoperative recheck of pedicle screws placed should be reduced
- The precision of placement of pedicle screw should not be adversely affected by the use of the system compared to conventional spinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: AQrate Robotic Assistance System | Experimental | Device: AQrate Robotic Assistance SystemPrecise positioning of surgical instruments and spinal implants during general spinal surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age from 18 years to 85 years) scheduled for spinal fusion surgery,
- Primary spinal surgery (It is the first surgery on this patient's spine)
- Patient is capable of complying with study requirements, and
- Patient is willing to provide a signed informed consent.
Key exclusion criteria (13 listed)
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
- Infection or malignancy
- Previous spondylodesis
- Previous spinal surgical procedures
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 |
|---|---|---|
| AQrate Robotic Assistance SystemRobotic guidance during spinal fusion surgery | Device | Device: AQrate Robotic Assistance System |
Primary outcome
clinical acceptance of the performance of the AQrate Robotic Assistance System.
Time frame: Day of surgery
The acceptance of the performance of the AQrate System will be measured by scale given to total of 8 questions.
2 secondary outcomes
Intraoperative exposure to radiation
Time frame: Day of surgery
Accuracy of spinal screws placed
Time frame: Within one month of surgery
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 10 May 2016.
- Background: PubMed 22190547Kostrzewski S, Duff JM, Baur C, Olszewski M. Robotic system for cervical spine surgery. Int J Med Robot. 2012 Jun;8(2):184-90. doi: 10.1002/rcs.446. Epub 2011 Dec 21.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Denis Patet, MD principal investigator
Clinic Genolier, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AQrate Robotic Assistance System in people with Degenerative Disc Disease and Spinal Stenosis, run by KB Medical SA at 2 sites in Switzerland.
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 13 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
clinical acceptance of the performance of the AQrate Robotic Assistance System. (time frame: Day of surgery). 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 NCT02558621, which also lists 1 linked publication.
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 10 May 2016.