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Patient Specific Template Guided Pedicle Instrumentation Versus Free Hand Technique

NCT03318692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-05-31

No results posted yet for this study

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

Interventions

PROCEDURE

spondylodesis

Dorsal instrumentation with transpedicular screws (spondylodesis)

PROCEDURE

CT

CT of operated area is performed within 7 days of surgery

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Mazda Farshad, Prof. Dr.med. · Balgrist University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-23
Primary Completion
2024-03-30
Completion
2024-03-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318692 on ClinicalTrials.gov