Pedicle Screw Positioning With MySpine vs Free Hand Technique

Medacta

Status: Completed

Conditions: Spinal Deformity

Treatments: Device: MUST pedicle screw; Procedure: Free hand technique pedicle screw positioning; Procedure: patient specific pedicle screw positioning guide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03369158

P05.005.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

MySpine

Experimental group

Description:

Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"

Treatment:

Device: MUST pedicle screw

Procedure: patient specific pedicle screw positioning guide

Free hand technique

Active Comparator group

Description:

Patients operated for spinal stabilization through standard free hand technique

Treatment:

Device: MUST pedicle screw

Procedure: Free hand technique pedicle screw positioning