Patient Specific Template Guided Pedicle Instrumentation Versus Free Hand Technique

Patient Specific Template Guided Pedicle Instrumentation Versus the Fluoroscopy Guided Free Hand Technique - a Randomized Prospective Trial

The clinically already tested and approved MySpine system is compared to the free-hand dorsal instrumentation, which is the gold standard in spondylodesis surgery. The aim of this study is to investigate whether or not the pedicle screw can be inserted anatomically more accurately by the MySpine system than by the conventional free-hand method using intraoperative fluoroscopy.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Diseases
• Intervention / Treatment: Procedure: spondylodesis; Procedure: CT

Detailed Description

Patients with an indication for spondylodesis are included according to the inclusion criteria and exclusion criteria. Subsequently, randomization into the MySpine and conventional group is performed. Patients remain blinded to the randomization.

On the basis of a computed tomography, the surgeon plans the entry points, the screw size and length, as well as the angle of the screws in two planes (sagittal and axial) on the computer. In the MySpine group, a three-dimensional, digital reconstruction of the spine is made using Medacta International SA software. On the basis of these planning files, three-dimensional templates with guide channels (guides) are produced for each individual vertebra. These guides can be applied dorsally to the bony anatomy and thus specify the entry points as well as the direction of the screw. Also, replicas of the individual vertebra are produced in the 3D printer.

The patients are operated in a prone position via a dorsal approach. After preparation of the dorsal process, vertebral arches and vertebral joints as well as the transverse process, the screws are implanted with one of the following methods depending on the randomization:

1. Freehand (fluoroscopically controlled)
2. MySpine System

Postoperatively, all patients undergo computed tomography of the operated area. On the basis of this computed tomography the number of pedicle perforations as well as their extent should be determined according to the simplified Laine classification. These results are to be statistically evaluated with the question of whether there are significant differences between the two techniques with respect to the absolute and individual number of pedicle perforations, as well as their extent. It is also to be examined whether these results show a dependence on the level of experience of the surgeon.

In addition to the individual radiation exposure (cumulative irradiation time in seconds and irradiation dose in cGy), the time for the dorsal instrumentation for each of the two systems per surgeon is also to be measured and evaluated.

In the follow-up, the outcome is also recorded by means of pain registration, ODI score and complication detection (infections, pedicle fractures, implant loosening, pseudoarthrosis, re-operations).

The follow-up assessments 6 weeks, 6 months, 1 year and 2 years after surgrey are peformed according to institutional standards.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8008
      • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Indication for spondylodesis independent of the study
• Signed consent
• Male and female patients aged 18 years and over

Exclusion Criteria:

• Polyamide-PA 12 allergy
• Pregnant or lactating women
• Known or suspected non-compliance with the protocol, drug or alcohol abuse
• inability of the patient to follow the trial procedure, e.g. Due to language problems, mental illness, dementia
• Prior participation in the clinical Trial
• Inclusion of the test person, his / her family members, employees or other dependent persons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MySpine System; pedicle screw implantation (spondylodesis) using the MySpine System. post surgery CT.	Procedure: spondylodesis; Dorsal instrumentation with transpedicular screws (spondylodesis); Procedure: CT; CT of operated area is performed within 7 days of surgery
Active Comparator: free-hand; Freehand (fluoroscopically controlled) implantation of pedicle screw (spondylodesis). Post surgery CT	Procedure: spondylodesis; Dorsal instrumentation with transpedicular screws (spondylodesis); Procedure: CT; CT of operated area is performed within 7 days of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy	Anatomical accuracy of pedicle screw implantation (intactness of the pediculate cortex in 3 planes), postoperatively measured via computertomographically existing or nonexisting pedicle perforation and their extent according to the simplified Laine classification: Grade A (<2 mm), Grade B (2-4 mm) and Grade C (> 4 mm)	within 7 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration	Intraoperative time spent on dorsal Instrumentation is documented and compared between the groups	during surgery
Radiation exposure	cummulative Radiation exposure during surgery is measured and compared between the groups	during surgery
blood loss	blood loss during surgery is documented and compared between the groups	during surgery
complications	intraoperative and post-operative complications such as pedicle fractures, implant loosening, infections and pseudo arthrosis are documented and compared between the groups	during surgery until end of follow up (24 months after surgery)
reoperations	reoperations are documented and compared between the groups	until end of follow up (24 months after surgery)

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Mazda Farshad, Prof. Dr.med., Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases
• Other Study ID Numbers: MySpine clinical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD only available to study personnel. statistical Analysis will be done with encoded data only. study results will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No