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N/A Completed N=29 Randomized Treatment

Pedicle Screw Positioning With MySpine vs Free Hand Technique

Spinal deformity
Source: ClinicalTrials.gov NCT03369158 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Accuracy of Pedicle Screw Positioning — 90.24; 83.13 percentage of screw

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Accuracy of Pedicle Screw Positioning		 90.24; 83.13 —
SECONDARY
Radiological Evaluation of Pedicle Screw Malposition		 224; 160; 44; 42; 16; 19 —
SECONDARY
Occurrence of Malposition Side		 19; 31; 46; 54 —
SECONDARY
Incidence of Adverse Event		 0; 0 —

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03369158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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