Pedicle Screw Positioning With MySpine vs Free Hand Technique (NCT03369158) | Clinical Trial Compass
CompletedNot Applicable
Pedicle Screw Positioning With MySpine vs Free Hand Technique
29 participantsStarted 2015-01-13
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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