The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.
Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO). Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
All patients receive posterior hybrid instrumentation.
University Hospital Cologne
Cologne, Germany
Changes in the health-related outcome measurement instruments (ODI)
Time frame: 24-48 months
Changes in the health-related outcome measurement instruments (COMI)
Time frame: 24-48 months
Changes in the health-related outcome measurement instruments (SF-36)
Time frame: 24-48 months
Radiological outcomes
Radiological changes within the adjacent segment
Time frame: 24-48 months
Device complication (breakage, loosening, etc.)
Complication regarding the device
Time frame: 24 - 48 months
Patient-related complication
general and surgical complication
Time frame: 24- 48 months
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