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NCT Number: NCT01367860

Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy

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.

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Key information

Conditions

Radiculopathy Back Pain Bone Diseases Hernia Herniated Disk Intervertebral Disc Displacement Low Back Pain Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Orthopedics and Traumatology of the USP

São Paulo, 05403-010, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open microdiscectomy

Procedure

The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.

Percutaneous Diskectomy SpineJet

Procedure

Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy.

Primary outcomes

  1. VAS for Lumbar Pain in 3 Months

    Time frame: 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.

  2. Oswestry Disability Index (ODI) - 3th Month

    Time frame: 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 outcomes

  1. Clinical Evaluation

    Time frame: 6th month

    Will be measured dichotomously: (present or absent)

    Variables:

    Infection; residual pain; herniation recurrency

  2. VAS for Lumbar - 1st Week

    Time frame: 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.

  3. VAS for Lumbar 1st Month

    Time frame: 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.

  4. VAS for Lumbar Pain - 3rd Month

    Time frame: 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.

  5. VAS for Lumbar Pain - 6th Month

    Time frame: 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.

  6. VAS for Lumbar Pain - 12th Month

    Time frame: 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.

  7. Oswestry Disability Index (ODI) - 1st Week

    Time frame: 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.

  8. Oswestry Disability Index (ODI) - 1st Month

    Time frame: 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.

  9. Oswestry Disability Index (ODI) - 6th Month

    Time frame: 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.

  10. Oswestry Disability Index (ODI) - 12th Month

    Time frame: 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.

  11. VAS for Leg Pain - 1st Week

    Time frame: 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.

  12. VAS for Leg Pain - 1st Month

    Time frame: 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.

  13. VAS for Leg Pain - 3rd Month

    Time frame: 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.

  14. VAS for Leg Pain - 6rd Month

    Time frame: 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.

  15. VAS for Leg Pain - 12th Month

    Time frame: 12th month from surgery

    pain scale - VAS for leg pain - 12th month

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Comparison of Percutaneous Diskectomy SpineJet x Open Microdiscectomy for Treatment of Lumbar Radiculopathy in Contained Disc Herniation: Randomized Clinical Trial

Acronym: PDOP_TLR

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 7, 2011
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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