Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy (PDOP_TLR)

University of Sao Paulo

Status: Completed

Conditions: Herniated Disk; Radiculopathy

Treatments: Procedure: Percutaneous Diskectomy SpineJet; Procedure: Open microdiscectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01367860

IOT (Other Identifier)

SpJet2011

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

OMicro

Active Comparator group

Description:

This group will be formed by randomization, which gets out surgery to open microdiscectomy

Treatment:

Procedure: Open microdiscectomy

SJet

Experimental group

Description:

This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet

Treatment:

Procedure: Percutaneous Diskectomy SpineJet