Spinal DeformityNCT03369158
Pedicle Screw Positioning With MySpine vs Free Hand Technique
A study testing patient specific pedicle screw positioning guide, Free hand technique pedicle screw positioning and MUST pedicle screw in people with Spinal Deformity, run by Medacta International SA.
Trial summary
Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- patient specific pedicle screw positioning guide, Free hand technique pedicle screw positioning and MUST pedicle screw
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2015to 13 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 12 years
- patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement
- Patients suitable to undergo spinal stabilization (according to the label indication/contraindications)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.
Who cannot join
- Patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block)
- Patients with a previous fusion of the spine in the region where screws will be inserted
- Patients with any allergy to the device implanted
- Patients who will be not able to provide their written consent to the study participation
- Patients who are incapable of understanding and wanting
About this study
Official title: A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique
Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique.
Read the detailed description
The proposed study seeks to assess the intraoperative accuracy of the Medacta patient-specific MySpine® pedicle screws placement guides in comparison to free-hand technique.
A pre-operative CT scan of the spine is obtained to create a 3-dimensional model of the patient's spine for the MySpine patient group. This model is then used to preoperatively plan the patient's surgery implantation itself, with the same goals of both free-hand and computer assisted techniques. The theoretical advantage of this technique is accurate implant placement without the added surgical time and complexity of the procedure, with lower radiation exposure thanks to less steps of fluoroscopy checks.
The hypothesis for the present study is that the MySpine® technique can place pedicle screws more accurately in comparison to free-hand technique.
The accuracy of the final implant position with respect to the pre-operative planning will be evaluated through CT post-op analysis.
- Conditions
- Spinal Deformity
- Being tested
- patient specific pedicle screw positioning guide, Free hand technique pedicle screw positioning, MUST pedicle screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient specific pedicle screw positioning guideProcedure or surgery
Also called MySpine
Free hand technique pedicle screw positioningProcedure or surgery
MUST pedicle screwDevice
| Study group | Role | What they receive |
|---|---|---|
| MySpine | Experimental | Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine" Receives: Procedure: patient specific pedicle screw positioning guide; Device: MUST pedicle screw |
| Free hand technique | Active comparator | Patients operated for spinal stabilization through standard free hand technique Receives: Procedure: Free hand technique pedicle screw positioning; Device: MUST pedicle screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Pedicle Screw Positioning
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
Measured: 1 week after surgery
Secondary outcomes (3)
Radiological Evaluation of Pedicle Screw Malposition
A CT will be performed before discharge to evaluate the severity of pedicle screws malposition according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as "safe area.". Level 0 (perfect corrected positioning of the screw), level A (0-2 mm of violation), level B (2-4 mm of violation), level C (˃4mm of violation). The better outcomes correspond to level 0 and the worst to level C.
Measured: 1 weeks after surgery
Occurrence of Malposition Side
Evaluation of malposition on the medial or lateral side
Measured: 1 weeks after surgery
Incidence of Adverse Event
Occurrence of intra-operative complications reporting
Measured: intraoperatively, up to 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start13 Jan 2015
- Primary completion11 Oct 2016
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal DeformityStudies 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
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369158
- Sponsor's protocol ID
- P05.005.01
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique
- ClinicalTrials.gov ID
- NCT03369158
- Acronym / sponsor ID
- P05.005.01
- Conditions
- Spinal Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2015 (actual)
- Primary completion
- 11 Oct 2016 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique.
Detailed description
The proposed study seeks to assess the intraoperative accuracy of the Medacta patient-specific MySpine® pedicle screws placement guides in comparison to free-hand technique.
A pre-operative CT scan of the spine is obtained to create a 3-dimensional model of the patient's spine for the MySpine patient group. This model is then used to preoperatively plan the patient's surgery implantation itself, with the same goals of both free-hand and computer assisted techniques. The theoretical advantage of this technique is accurate implant placement without the added surgical time and complexity of the procedure, with lower radiation exposure thanks to less steps of fluoroscopy checks.
The hypothesis for the present study is that the MySpine® technique can place pedicle screws more accurately in comparison to free-hand technique.
The accuracy of the final implant position with respect to the pre-operative planning will be evaluated through CT post-op analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MySpine | Experimental | Procedure: patient specific pedicle screw positioning guide, Device: MUST pedicle screwPatients operated for spinal stabilization through patient specific pedicle screw guide "MySpine" |
| Free hand technique | Active comparator | Procedure: Free hand technique pedicle screw positioning, Device: MUST pedicle screwPatients operated for spinal stabilization through standard free hand technique |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 12 years
- patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement
- Patients suitable to undergo spinal stabilization (according to the label indication/contraindications)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.
Key exclusion criteria (5 listed)
- Patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block)
- Patients with a previous fusion of the spine in the region where screws will be inserted
- Patients with any allergy to the device implanted
- Patients who will be not able to provide their written consent to the study participation
- Patients who are incapable of understanding and wanting
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 |
|---|---|---|
| patient specific pedicle screw positioning guideAlso: MySpine | Procedure or surgery | MySpine |
| Free hand technique pedicle screw positioning | Procedure or surgery | Free hand technique |
| MUST pedicle screw | Device | Free hand technique, MySpine |
Primary outcome
Accuracy of Pedicle Screw Positioning
Time frame: 1 week after surgery
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
3 secondary outcomes
Radiological Evaluation of Pedicle Screw Malposition
Time frame: 1 weeks after surgery
Occurrence of Malposition Side
Time frame: 1 weeks after surgery
Incidence of Adverse Event
Time frame: intraoperatively, up to 1 week after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing patient specific pedicle screw positioning guide, Free hand technique pedicle screw positioning and MUST pedicle screw in people with Spinal Deformity, run by Medacta International SA.
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 5 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Pedicle Screw Positioning (time frame: 1 week after 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 2 Sep 2020.