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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Deformity
• Intervention / Treatment: Procedure: patient specific pedicle screw positioning guide; Device: MUST pedicle screw; Procedure: Free hand technique pedicle screw positioning

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MySpine; Patients operated for spinal stabilization through patient specific pedicle screw guide "MySpine"	Procedure: patient specific pedicle screw positioning guide; Other Names: MySpine; Device: MUST pedicle screw
ACTIVE_COMPARATOR: Free hand technique; Patients operated for spinal stabilization through standard free hand technique	Device: MUST pedicle screw; Procedure: Free hand technique pedicle screw positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Occurrence of Malposition Side	Evaluation of malposition on the medial or lateral side	1 weeks after surgery
Incidence of Adverse Event	Occurrence of intra-operative complications reporting	intraoperatively, up to 1 week after surgery

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2015
• Primary Completion (ACTUAL): October 11, 2016
• Study Completion (ACTUAL): February 13, 2017

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (ACTUAL): December 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: P05.005.01