Spinal Cord DiseasesNCT03318692
Patient Specific Template Guided Pedicle Instrumentation Versus Free Hand Technique
A study testing spondylodesis and CT in people with Spinal Cord Diseases, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The clinically already tested and approved MySpine system is compared to the free-hand dorsal instrumentation, which is the gold standard in spondylodesis surgery. The aim of this study is to investigate whether or not the pedicle screw can be inserted anatomically more accurately by the MySpine system than by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Diseases
- What is being tested?
- spondylodesis and CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jun 2017to 31 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for spondylodesis independent of the study
- Signed consent
- Male and female patients aged 18 years and over
Who cannot join
- Polyamide-PA 12 allergy
- Pregnant or lactating women
- Known or suspected non-compliance with the protocol, drug or alcohol abuse
- inability of the patient to follow the trial procedure, e.g. Due to language problems, mental illness, dementia
- Prior participation in the clinical Trial
- Inclusion of the test person, his / her family members, employees or other dependent persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Patient Specific Template Guided Pedicle Instrumentation Versus the Fluoroscopy Guided Free Hand Technique - a Randomized Prospective Trial
The clinically already tested and approved MySpine system is compared to the free-hand dorsal instrumentation, which is the gold standard in spondylodesis surgery. The aim of this study is to investigate whether or not the pedicle screw can be inserted anatomically more accurately by the MySpine system than by the conventional free-hand method using intraoperative fluoroscopy.
Read the detailed description
Patients with an indication for spondylodesis are included according to the inclusion criteria and exclusion criteria. Subsequently, randomization into the MySpine and conventional group is performed. Patients remain blinded to the randomization.
On the basis of a computed tomography, the surgeon plans the entry points, the screw size and length, as well as the angle of the screws in two planes (sagittal and axial) on the computer. In the MySpine group, a three-dimensional, digital reconstruction of the spine is made using Medacta International SA software. On the basis of these planning files, three-dimensional templates with guide channels (guides) are produced for each individual vertebra. These guides can be applied dorsally to the bony anatomy and thus specify the entry points as well as the direction of the screw. Also, replicas of the individual vertebra are produced in the 3D printer.
The patients are operated in a prone position via a dorsal approach. After preparation of the dorsal process, vertebral arches and vertebral joints as well as the transverse process, the screws are implanted with one of the following methods depending on the randomization:
- Freehand (fluoroscopically controlled)
- MySpine System
Postoperatively, all patients undergo computed tomography of the operated area. On the basis of this computed tomography the number of pedicle perforations as well as their extent should be determined according to the simplified Laine classification. These results are to be statistically evaluated with the question of whether there are significant differences between the two techniques with respect to the absolute and individual number of pedicle perforations, as well as their extent. It is also to be examined whether these results show a dependence on the level of experience of the surgeon.
In addition to the individual radiation exposure (cumulative irradiation time in seconds and irradiation dose in cGy), the time for the dorsal instrumentation for each of the two systems per surgeon is also to be measured and evaluated.
In the follow-up, the outcome is also recorded by means of pain registration, ODI score and complication detection (infections, pedicle fractures, implant loosening, pseudoarthrosis, re-operations).
The follow-up assessments 6 weeks, 6 months, 1 year and 2 years after surgrey are peformed according to institutional standards.
- Conditions
- Spinal Cord Diseases
- Being tested
- spondylodesis, CT
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spondylodesisProcedure or surgery
Dorsal instrumentation with transpedicular screws (spondylodesis)
CTProcedure or surgery
CT of operated area is performed within 7 days of surgery
| Study group | Role | What they receive |
|---|---|---|
| MySpine System | Experimental | pedicle screw implantation (spondylodesis) using the MySpine System. post surgery CT. Receives: Procedure: spondylodesis; Procedure: CT |
| free-hand | Active comparator | Freehand (fluoroscopically controlled) implantation of pedicle screw (spondylodesis). Post surgery CT Receives: Procedure: spondylodesis; Procedure: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
Anatomical accuracy of pedicle screw implantation (intactness of the pediculate cortex in 3 planes), postoperatively measured via computertomographically existing or nonexisting pedicle perforation and their extent according to the simplified Laine classification: Grade A (<2 mm), Grade B (2-4 mm) and Grade C (> 4 mm)
Measured: within 7 days post surgery
Secondary outcomes (5)
duration
Intraoperative time spent on dorsal Instrumentation is documented and compared between the groups
Measured: during surgery
Radiation exposure
cummulative Radiation exposure during surgery is measured and compared between the groups
Measured: during surgery
blood loss
blood loss during surgery is documented and compared between the groups
Measured: during surgery
complications
intraoperative and post-operative complications such as pedicle fractures, implant loosening, infections and pseudo arthrosis are documented and compared between the groups
Measured: during surgery until end of follow up (24 months after surgery)
reoperations
reoperations are documented and compared between the groups
Measured: until end of follow up (24 months after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start23 Jun 2017
- Primary completion30 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, partially blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazda Farshad, Prof. Dr.med., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318692
- Sponsor's protocol ID
- MySpine clinical
- Status last verified
- May 2024
- First submitted
- 29 Jun 2017
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD only available to study personnel. statistical Analysis will be done with encoded data only. study results will be published
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Template Guided Pedicle Instrumentation Versus the Fluoroscopy Guided Free Hand Technique - a Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT03318692
- Acronym / sponsor ID
- MySpine clinical
- Conditions
- Spinal Cord Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 24 Oct 2017 (actual)
- 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 clinically already tested and approved MySpine system is compared to the free-hand dorsal instrumentation, which is the gold standard in spondylodesis surgery. The aim of this study is to investigate whether or not the pedicle screw can be inserted anatomically more accurately by the MySpine system than by the conventional free-hand method using intraoperative fluoroscopy.
Detailed description
Patients with an indication for spondylodesis are included according to the inclusion criteria and exclusion criteria. Subsequently, randomization into the MySpine and conventional group is performed. Patients remain blinded to the randomization.
On the basis of a computed tomography, the surgeon plans the entry points, the screw size and length, as well as the angle of the screws in two planes (sagittal and axial) on the computer. In the MySpine group, a three-dimensional, digital reconstruction of the spine is made using Medacta International SA software. On the basis of these planning files, three-dimensional templates with guide channels (guides) are produced for each individual vertebra. These guides can be applied dorsally to the bony anatomy and thus specify the entry points as well as the direction of the screw. Also, replicas of the individual vertebra are produced in the 3D printer.
The patients are operated in a prone position via a dorsal approach. After preparation of the dorsal process, vertebral arches and vertebral joints as well as the transverse process, the screws are implanted with one of the following methods depending on the randomization:
- Freehand (fluoroscopically controlled)
- MySpine System
Postoperatively, all patients undergo computed tomography of the operated area. On the basis of this computed tomography the number of pedicle perforations as well as their extent should be determined according to the simplified Laine classification. These results are to be statistically evaluated with the question of whether there are significant differences between the two techniques with respect to the absolute and individual number of pedicle perforations, as well as their extent. It is also to be examined whether these results show a dependence on the level of experience of the surgeon.
In addition to the individual radiation exposure (cumulative irradiation time in seconds and irradiation dose in cGy), the time for the dorsal instrumentation for each of the two systems per surgeon is also to be measured and evaluated.
In the follow-up, the outcome is also recorded by means of pain registration, ODI score and complication detection (infections, pedicle fractures, implant loosening, pseudoarthrosis, re-operations).
The follow-up assessments 6 weeks, 6 months, 1 year and 2 years after surgrey are peformed according to institutional standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, randomized, partially blinded
| Arm | Type | Receives |
|---|---|---|
| MySpine System | Experimental | Procedure: spondylodesis, Procedure: CTpedicle screw implantation (spondylodesis) using the MySpine System. post surgery CT. |
| free-hand | Active comparator | Procedure: spondylodesis, Procedure: CTFreehand (fluoroscopically controlled) implantation of pedicle screw (spondylodesis). Post surgery CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for spondylodesis independent of the study
- Signed consent
- Male and female patients aged 18 years and over
Key exclusion criteria (6 listed)
- Polyamide-PA 12 allergy
- Pregnant or lactating women
- Known or suspected non-compliance with the protocol, drug or alcohol abuse
- inability of the patient to follow the trial procedure, e.g. Due to language problems, mental illness, dementia
- Prior participation in the clinical Trial
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 |
|---|---|---|
| spondylodesisDorsal instrumentation with transpedicular screws (spondylodesis) | Procedure or surgery | MySpine System, free-hand |
| CTCT of operated area is performed within 7 days of surgery | Procedure or surgery | MySpine System, free-hand |
Primary outcome
accuracy
Time frame: within 7 days post surgery
Anatomical accuracy of pedicle screw implantation (intactness of the pediculate cortex in 3 planes), postoperatively measured via computertomographically existing or nonexisting pedicle perforation and their extent according to the simplified Laine classification: Grade A (<2 mm), Grade B (2-4 mm) and Grade C (> 4 mm)
5 secondary outcomes
duration
Time frame: during surgery
Radiation exposure
Time frame: during surgery
blood loss
Time frame: during surgery
complications
Time frame: during surgery until end of follow up (24 months after surgery)
reoperations
Time frame: until end of follow up (24 months after 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 31 May 2024.
- Individual participant dataSharing planned: No. IPD only available to study personnel. statistical Analysis will be done with encoded data only. study results will be published
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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.
Mazda Farshad, Prof. Dr.med. principal investigator
Balgrist University 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 spondylodesis and CT in people with Spinal Cord Diseases, run by Balgrist University Hospital at 1 site 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 3 inclusion and 6 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 May 2024. 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 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?
accuracy (time frame: within 7 days post surgery). 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 May 2024.