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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Accuracy of Pedicle Screw Positioning
Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.
Time frame: 1 week after surgery
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.
Time frame: 1 weeks after surgery
Occurrence of Malposition Side
Evaluation of malposition on the medial or lateral side
Time frame: 1 weeks after surgery
Incidence of Adverse Event
Occurrence of intra-operative complications reporting
Time frame: intraoperatively, up to 1 week after surgery
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