Status:
COMPLETED
Pedicle Screw Positioning With MySpine vs Free Hand Technique
Lead Sponsor:
Medacta International SA
Conditions:
Spinal Deformity
Eligibility:
All Genders
12+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2017
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03369158
Start Date
January 13 2015
End Date
February 13 2017
Last Update
September 2 2020
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