Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy

Not Applicable

Completed

Conditions: Radiculopathy
Herniated Disk

Interventions: Procedure: Percutaneous Diskectomy SpineJet
Procedure: Open microdiscectomy

Registration Number: NCT01367860

Lead Sponsor: University of Sao Paulo

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SJet	Percutaneous Diskectomy SpineJet	This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
OMicro	Open microdiscectomy	This group will be formed by randomization, which gets out surgery to open microdiscectomy

Primary Outcome Measures

Name	Time	Method
VAS for Lumbar Pain in 3 Months	VAS for Lumbar Pain at 3 Months	Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Oswestry Disability Index (ODI) - 3th Month	3th month	Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.

Secondary Outcome Measures

Name	Time	Method
VAS for Leg Pain - 1st Month	1st month from surgery	Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
VAS for Leg Pain - 12th Month	12th month from surgery	pain scale - VAS for leg pain - 12th month
VAS for Lumbar 1st Month	1st month from surgery	Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
VAS for Lumbar Pain - 3rd Month	3rd month from surgery	Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Clinical Evaluation	6th month	Will be measured dichotomously: (present or absent) Variables: Infection; residual pain; herniation recurrency
VAS for Leg Pain - 1st Week	1st week from surgery	Pain Score for leg pain- Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
VAS for Lumbar - 1st Week	1st week from surgery	Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
VAS for Lumbar Pain - 6th Month	6th month from surgery	Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
VAS for Lumbar Pain - 12th Month	12th month from surgery	Pain Score - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Oswestry Disability Index (ODI) - 1st Month	1st month from baseline	Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
Oswestry Disability Index (ODI) - 6th Month	6th month from surgery	Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
VAS for Leg Pain - 3rd Month	3rd month from surgery	Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
VAS for Leg Pain - 6rd Month	6th month from surgery	Pain Score for leg pain - Visual Analog Scale (VAS) -\> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.
Oswestry Disability Index (ODI) - 1st Week	1st week minus baseline	Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.
Oswestry Disability Index (ODI) - 12th Month	12th month from surgery	Oswestry Disability Index (ODI) -\> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome.