Pedicle Screw Positioning With MySpine vs Free Hand Technique

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369158
• Other study ID #: P05.005.01
• Status: Completed
• Phase: N/A
• Start date: January 13, 2015
• Est. completion date: February 13, 2017

Study information

• Verified date: November 2017
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 13, 2017
• Est. primary completion date: October 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

Intervention

Procedure:
• patient specific pedicle screw positioning guide

• Free hand technique pedicle screw positioning

Device:
• MUST pedicle screw

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Pedicle Screw Positioning	Pedicle screw accuracy is defined as having the entire screw contained within the cortices of each respective pedicle.	1 week after surgery
Secondary	Radiological Evaluation of Pedicle Screw Malposition	A CT will be performed before discharge to evaluate the severity of pedicle screws malposition according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as "safe area.". Level 0 (perfect corrected positioning of the screw), level A (0-2 mm of violation), level B (2-4 mm of violation), level C (?4mm of violation). The better outcomes correspond to level 0 and the worst to level C.	1 weeks after surgery
Secondary	Occurrence of Malposition Side	Evaluation of malposition on the medial or lateral side	1 weeks after surgery
Secondary	Incidence of Adverse Event	Occurrence of intra-operative complications reporting	intraoperatively, up to 1 week after surgery