Pedicle Screw Positioning With MySpine vs Free Hand Technique

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique

Conditions
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Spinal Deformity

Intervention / Treatment
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* Procedure: patient specific pedicle screw positioning guide
* Procedure: Free hand technique pedicle screw positioning
* Device: MUST pedicle screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MySpine<br>Patients operated for spinal stabilization through patient specific pedicle screw guide MySpine | Procedure: patient specific pedicle screw positioning guide<br> <br> * Other names: MySpine;Device: MUST pedicle screw<br> <br> |
| Active Comparator: Free hand technique<br>Patients operated for spinal stabilization through standard free hand technique | Procedure: Free hand technique pedicle screw positioning<br> <br> Device: MUST pedicle screw<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Pedicle Screw Positioning | Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle. | 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 weeks after surgery | 
| Occurrence of Malposition Side | Evaluation of malposition on the medial or lateral side | 1 weeks after surgery | 
| Incidence of Adverse Event | Occurrence of intra-operative complications reporting | intraoperatively, up to 1 week after surgery |