Clinical trial NCT01367860: Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy
Official title: Comparison of Percutaneous Diskectomy SpineJet x Open Microdiscectomy for Treatment of Lumbar Radiculopathy in Contained Disc Herniation: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy
Herniated Disk
Keywords: spine surgery
low back pain
herniated disk
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* single disc herniation, posterolateral, at any lumbar level, with a size of up to 1 / 3 of the spinal canal sagittal diameter, with radicular pain correlated with findings at MRI
* Failure of nonoperative treatment with at least one anti-inflammatory medication and at least two weeks of physical therapy within a period of 6 months
* acceptance of completion of informed consent

Exclusion Criteria:

* Force \<4 / 5 in a muscle group in the lower limb
* Herniated Disc extrusa large (\> 1 / 3 of the sagittal canal diameter) or sequestered herniation
* moderate to grade stenosis of the central canal, lateral recess or foramen
* Surgery in the previous level involved
* Herniated disc at another level in the affected side
* Loss of disc height significantly (\> 60%) compared with the adjacent higher level
* Infection at the insertion of the device
* Pregnancy
* Any illness or medications that contraindicate surgical treatment

Primary outcomes:
measure: VAS for Lumbar Pain in 3 Months
timeFrame: VAS for Lumbar Pain at 3 Months
measure: Oswestry Disability Index (ODI) - 3th Month
timeFrame: 3th month
Secondary outcomes:
measure: Clinical Evaluation
timeFrame: 6th month
measure: VAS for Lumbar - 1st Week
timeFrame: 1st week from surgery
measure: VAS for Lumbar 1st Month
timeFrame: 1st month from surgery
measure: VAS for Lumbar Pain - 3rd Month
timeFrame: 3rd month from surgery
measure: VAS for Lumbar Pain - 6th Month
timeFrame: 6th month from surgery
measure: VAS for Lumbar Pain - 12th Month
timeFrame: 12th month from surgery
measure: Oswestry Disability Index (ODI) - 1st Week
timeFrame: 1st week minus baseline
measure: Oswestry Disability Index (ODI) - 1st Month
timeFrame: 1st month from baseline
measure: Oswestry Disability Index (ODI) - 6th Month
timeFrame: 6th month from surgery
measure: Oswestry Disability Index (ODI) - 12th Month
timeFrame: 12th month from surgery
measure: VAS for Leg Pain - 1st Week
timeFrame: 1st week from surgery
measure: VAS for Leg Pain - 1st Month
timeFrame: 1st month from surgery
measure: VAS for Leg Pain - 3rd Month
timeFrame: 3rd month from surgery
measure: VAS for Leg Pain - 6rd Month
timeFrame: 6th month from surgery
measure: VAS for Leg Pain - 12th Month
timeFrame: 12th month from surgery
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Institute of Orthopedics and Traumatology of the USP
Study officials:
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