NCT03369158

Pedicle Screw Positioning With MySpine vs Free Hand Technique

A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Deformity

Interventions

Type	Name	Description
PROCEDURE	patient specific pedicle screw positioning guide
PROCEDURE	Free hand technique pedicle screw positioning
DEVICE	MUST pedicle screw

Timeline

• Start date: 2015-01-13
• Primary completion: 2016-10-11
• Completion: 2017-02-13
• First posted: 2017-12-11
• Last updated: 2020-09-02
• Results posted: 2020-09-02