Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?
Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS). Key secondary endpoint(s): 1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 2. Individual dimensions of the Oswestry Disability Index (ODI) 3. Time until radiological adjacent instability and comparison to the clinical outcome 4. Capacity of work at the time of surgery and after surgery, time until return to work Assessment of safety: 1. Treatment complication in control and intervention groups (SAE-management) 2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
University of Cologne, Department of Orthopedics& traumasurgery
Cologne, Germany
SF36
Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).
Time frame: 6 Month
1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36
1\. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Time frame: 6 weeks
Safety
Assessment of safety: 1. Treatment complication in control and intervention groups (SAE-management) 2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias
Time frame: all time
Individual dimensions of the Oswestry Disability Index (ODI)
Individual dimensions of the Oswestry Disability Index (ODI) follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Time frame: 6weeks
Time until radiological adjacent instability and comparison to the clinical outcome
Time until radiological adjacent instability and comparison to the clinical outcome follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Time frame: 6 weeks
Capacity of work at the time of surgery and after surgery, time until return to work
Capacity of work at the time of surgery and after surgery, time until return to work follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
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Time frame: 6 weeks