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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexandre F. Cristante, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01367860
First received: May 31, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Radiculopathy
Herniated Disk
Procedure: Open microdiscectomy
Procedure: Percutaneous Diskectomy SpineJet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Percutaneous Diskectomy SpineJet x Open Microdiscectomy for Treatment of Lumbar Radiculopathy in Contained Disc Herniation: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • VAS for Lumbar Pain in 3 Months [ Time Frame: VAS for Lumbar Pain at 3 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3th month ] [ Designated as safety issue: No ]

    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:
  • Clinical Evaluation [ Time Frame: 6th month ] [ Designated as safety issue: Yes ]

    Will be measured dichotomously: (present or absent)

    Variables:

    Infection; residual pain; herniation recurrency


  • VAS for Lumbar - 1st Week [ Time Frame: 1st week from surgery ] [ Designated as safety issue: No ]
    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 1st Month [ Time Frame: 1st month from surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3rd month from surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6th month from surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12th month from surgery ] [ Designated as safety issue: Yes ]
    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 Week [ Time Frame: 1st week minus baseline ] [ Designated as safety issue: No ]

    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) - 1st Month [ Time Frame: 1st month from baseline ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6th month from surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12th month from surgery ] [ Designated as safety issue: No ]

    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 - 1st Week [ Time Frame: 1st week from surgery ] [ Designated as safety issue: No ]
    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 - 1st Month [ Time Frame: 1st month from surgery ] [ Designated as safety issue: No ]
    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 - 3rd Month [ Time Frame: 3rd month from surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6th month from surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12th month from surgery ] [ Designated as safety issue: No ]
    pain scale - VAS for leg pain - 12th month


Enrollment: 40
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OMicro
This group will be formed by randomization, which gets out surgery to open microdiscectomy
Procedure: Open microdiscectomy
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.
Experimental: SJet
This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet
Procedure: Percutaneous Diskectomy SpineJet
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.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367860

Locations
Brazil
Institute of Orthopedics and Traumatology of the USP
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications:
Hijikata S, Yamagishi M, Nakayama T, Oomori K. Percutaneous nucleotomy: a new treatment method for lumbar disk herniation. J Toden Hosp 1976, 6:6-13

Responsible Party: Alexandre F. Cristante, PhD., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01367860     History of Changes
Other Study ID Numbers: SpJet2011, IOT
Study First Received: May 31, 2011
Results First Received: April 1, 2013
Last Updated: May 19, 2014
Health Authority: Brasil: Institutional Review Board IOT USP

Keywords provided by University of Sao Paulo:
spine surgery
low back pain
herniated disk

Additional relevant MeSH terms:
Radiculopathy
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014