Patient Specific Template Guided Pedicle Instrumentation Versus Free Hand Technique

NCT03318692 | Completed DMC

• 1 other identifier: MySpine clinical
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• duration

  during surgery

• Radiation exposure

  during surgery

• blood loss

  during surgery

• complications

  during surgery until end of follow up (24 months after surgery)

• reoperations

  until end of follow up (24 months after surgery)

Study Arms (2)

MySpine System

EXPERIMENTAL

pedicle screw implantation (spondylodesis) using the MySpine System. post surgery CT.

Procedure: spondylodesis; Procedure: CT

free-hand

ACTIVE COMPARATOR

Freehand (fluoroscopically controlled) implantation of pedicle screw (spondylodesis). Post surgery CT

Procedure: spondylodesis; Procedure: CT

Interventions

spondylodesis PROCEDURE

Dorsal instrumentation with transpedicular screws (spondylodesis)

MySpine System; free-hand

CT PROCEDURE

CT of operated area is performed within 7 days of surgery

MySpine System; free-hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Diseases

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Arthrodesis; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Mazda Farshad, Prof. Dr.med.

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient is masked to the surgery procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, partially blinded

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: October 24, 2017
• Study Start: June 23, 2017
• Primary Completion: March 30, 2024
• Study Completion: March 31, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)