Status:
COMPLETED
Patient Specific Template Guided Pedicle Instrumentation Versus Free Hand Technique
Lead Sponsor:
Balgrist University Hospital
Conditions:
Spinal Cord Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 investig...
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....
Eligibility Criteria
Inclusion
- Indication for spondylodesis independent of the study
- Signed consent
- Male and female patients aged 18 years and over
Exclusion
- 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
Key Trial Info
Start Date :
June 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03318692
Start Date
June 23 2017
End Date
March 31 2024
Last Update
May 31 2024
Active Locations (1)
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1
Balgrist University Hospital
Zurich, Canton of Zurich, Switzerland, 8008