Pedicle Screw Positioning With MySpine vs Free Hand Technique

NCT ID: NCT03369158

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-13
• Study Completion Date: 2017-02-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MySpine

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

Group Type: EXPERIMENTAL

patient specific pedicle screw positioning guide

Intervention Type: PROCEDURE

MUST pedicle screw

Intervention Type: DEVICE

Free hand technique

Patients operated for spinal stabilization through standard free hand technique

Group Type: ACTIVE_COMPARATOR

Free hand technique pedicle screw positioning

Intervention Type: PROCEDURE

MUST pedicle screw

Intervention Type: DEVICE

Interventions

patient specific pedicle screw positioning guide

Intervention Type: PROCEDURE

Free hand technique pedicle screw positioning

Intervention Type: PROCEDURE

MUST pedicle screw

Intervention Type: DEVICE

Other Intervention Names

MySpine

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medacta International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05.005.01

Identifier Type: -

Identifier Source: org_study_id