Spondylolisthesis Clinical Trial
Official title:
Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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