Radiculopathy Clinical Trial
Official title:
Comparison of Percutaneous Diskectomy SpineJet x Open Microdiscectomy for Treatment of Lumbar Radiculopathy in Contained Disc Herniation: Randomized Clinical Trial
Approximately 300,000 patients undergo open surgical procedures to treat symptoms caused by
disc herniation.
Among the various surgical techniques practiced the percutaneous discectomy occupies its
space since the first description of the technique by Hijikata, 1975. Throughout, many
techniques have been described. Studies indicate that the treatment was successful for pain
and disability resulting from herniated disc associated with radiculopathy small.
However, some methods remove very small amounts of tissue with little change in volume of
the disc. Thus, studies on the cadaver with Percutaneous Diskectomy by SpineJet ® showed
more macroscopic changes of the disc with a predictable amount of removal and significant
disc material.
The Percutaneous Diskectomy by SpineJet ® is a new technique of percutaneous diskectomy
which creates a suction effect in tissues adjacent to the exit point of the fluid and the
opening point of the collector. However, no studies have examined the effect of the
Percutaneous Diskectomy by SpineJet ® in humans about the disk size after treatment or
measures of disc degeneration by imaging methods or how these characteristics might
correlate with clinical outcomes.
Thus, the study will compare outcomes of patients with contained or extruded disc
herniation, with complaints of radiculopathy, concordant with the imaging findings. With
treatment by surgical technique or the traditional by SpineJet ®, in order to determine
whether percutaneous discectomy with SpineJet ® will produce results comparable to open
microdiskectomy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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