Pedicle Screw Positioning With MySpine vs Free Hand Technique

Not Applicable

Completed

Interventions: Procedure: patient specific pedicle screw positioning guide
Procedure: Free hand technique pedicle screw positioning
Device: MUST pedicle screw

Brief 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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
MySpine	patient specific pedicle screw positioning guide	Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
Free hand technique	Free hand technique pedicle screw positioning	Patients operated for spinal stabilization through standard free hand technique
MySpine	MUST pedicle screw	Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"
Free hand technique	MUST pedicle screw	Patients operated for spinal stabilization through standard free hand technique

Primary Outcome Measures

Name	Time	Method
Accuracy of Pedicle Screw Positioning	1 week after surgery	Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Malposition Side	1 weeks after surgery	Evaluation of malposition on the medial or lateral side
Incidence of Adverse Event	intraoperatively, up to 1 week after surgery	Occurrence of intra-operative complications reporting
Radiological Evaluation of Pedicle Screw Malposition	1 weeks after surgery	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.