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

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

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.

Study Overview

• Status: Completed
• Conditions: Radiculopathy; Herniated Disk
• Intervention / Treatment: Procedure: Open microdiscectomy; Procedure: Percutaneous Diskectomy SpineJet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-010
    • Institute of Orthopedics and Traumatology of the USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS for Lumbar Pain in 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.	VAS for Lumbar Pain at 3 Months
Oswestry Disability Index (ODI) - 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.	3th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation	Will be measured dichotomously: (present or absent) Variables: Infection; residual pain; herniation recurrency	6th month
VAS for Lumbar - 1st Week	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.	1st week from surgery
VAS for Lumbar 1st Month	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.	1st month from surgery
VAS for Lumbar Pain - 3rd Month	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.	3rd month from surgery
VAS for Lumbar Pain - 6th Month	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.	6th month from surgery
VAS for Lumbar Pain - 12th Month	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.	12th month from surgery
Oswestry Disability Index (ODI) - 1st Week	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.	1st week minus baseline
Oswestry Disability Index (ODI) - 1st 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.	1st month from baseline
Oswestry Disability Index (ODI) - 6th 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.	6th month from surgery
Oswestry Disability Index (ODI) - 12th 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.	12th month from surgery
VAS for Leg Pain - 1st Week	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.	1st week from surgery
VAS for Leg Pain - 1st Month	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.	1st month from surgery
VAS for Leg Pain - 3rd Month	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.	3rd month from surgery
VAS for Leg Pain - 6rd Month	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.	6th month from surgery
VAS for Leg Pain - 12th Month	pain scale - VAS for leg pain - 12th month	12th month from surgery

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Vigatto R, Alexandre NM, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity. Spine (Phila Pa 1976). 2007 Feb 15;32(4):481-6. doi: 10.1097/01.brs.0000255075.11496.47.
• Pauza KJ, Howell S, Dreyfuss P, Peloza JH, Dawson K, Bogduk N. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004 Jan-Feb;4(1):27-35. doi: 10.1016/j.spinee.2003.07.001.
• 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
• Choy DS, Hellinger J, Tassi GP, Hellinger S. Percutaneous laser disc decompression. Photomed Laser Surg. 2007 Feb;25(1):60. doi: 10.1089/pho.2006.9999. No abstract available.
• Davis GW, Onik G. Clinical experience with automated percutaneous lumbar discectomy. Clin Orthop Relat Res. 1989 Jan;(238):98-103.
• Mochida J, Toh E, Nomura T, Nishimura K. The risks and benefits of percutaneous nucleotomy for lumbar disc herniation. A 10-year longitudinal study. J Bone Joint Surg Br. 2001 May;83(4):501-5. doi: 10.1302/0301-620x.83b4.11508.
• Choy DS. Percutaneous laser disc decompression (PLDD): 352 cases with an 8 1/2-year follow-up. J Clin Laser Med Surg. 1995 Feb;13(1):17-21. doi: 10.1089/clm.1995.13.17.
• Wang JC, Shapiro MS, Hatch JD, Knight J, Dorey FJ, Delamarter RB. The outcome of lumbar discectomy in elite athletes. Spine (Phila Pa 1976). 1999 Mar 15;24(6):570-3. doi: 10.1097/00007632-199903150-00014.
• Casey KF, Chang MK, O'Brien ED, Yuan HA, McCullen GM, Schaffer J, Kambin P. Arthroscopic microdiscectomy: comparison of preoperative and postoperative imaging studies. Arthroscopy. 1997 Aug;13(4):438-45. doi: 10.1016/s0749-8063(97)90121-3.
• Delamarter RB, Howard MW, Goldstein T, Deutsch AL, Mink JH, Dawson EG. Percutaneous lumbar discectomy. Preoperative and postoperative magnetic resonance imaging. J Bone Joint Surg Am. 1995 Apr;77(4):578-84. doi: 10.2106/00004623-199504000-00011.
• Tonami H, Yokota H, Nakagawa T, Higashi K, Okimura T, Yamamoto I, Nishijima Y. Percutaneous laser discectomy: MR findings within the first 24 hours after treatment and their relationship to clinical outcome. Clin Radiol. 1997 Dec;52(12):938-44. doi: 10.1016/s0009-9260(97)80228-0.
• Krugluger J, Knahr K. Chemonucleolysis and automated percutaneous discectomy--a prospective randomized comparison. Int Orthop. 2000;24(3):167-9. doi: 10.1007/s002640000139.
• Dullerud R, Nakstad PH. Side effects and complications of automated percutaneous lumbar nucleotomy. Neuroradiology. 1997 Apr;39(4):282-5. doi: 10.1007/s002340050410.
• Wittenberg RH, Oppel S, Rubenthaler FA, Steffen R. Five-year results from chemonucleolysis with chymopapain or collagenase: a prospective randomized study. Spine (Phila Pa 1976). 2001 Sep 1;26(17):1835-41. doi: 10.1097/00007632-200109010-00002.
• Slotman GJ, Stein SC. Laminectomy compared with laparoscopic diskectomy and outpatient laparoscopic diskectomy for herniated L5-S1 intervertebral disks. J Laparoendosc Adv Surg Tech A. 1998 Oct;8(5):261-7. doi: 10.1089/lap.1998.8.261.
• Amoretti N, Huchot F, Flory P, Brunner P, Chevallier P, Bruneton JN. Percutaneous nucleotomy: preliminary communication on a decompression probe (Dekompressor) in percutaneous discectomy. Ten case reports. Clin Imaging. 2005 Mar-Apr;29(2):98-101. doi: 10.1016/j.clinimag.2004.10.024.
• Matsui H, Aoki M, Kanamori M. Lateral disc herniation following percutaneous lumbar discectomy. A case report. Int Orthop. 1997;21(3):169-71. doi: 10.1007/s002640050143.
• Mayer HM, Brock M. Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy. J Neurosurg. 1993 Feb;78(2):216-25. doi: 10.3171/jns.1993.78.2.0216.
• Teng GJ, Jeffery RF, Guo JH, He SC, Zhu HZ, Wang XH, Wu YZ, Lu JM, Ling XL, Qian Y, Zhang YM, Zhu MJ, Guan L, He XM. Automated percutaneous lumbar discectomy: a prospective multi-institutional study. J Vasc Interv Radiol. 1997 May-Jun;8(3):457-63. doi: 10.1016/s1051-0443(97)70589-x.
• Bernhardt M, Gurganious LR, Bloom DL, White AA 3rd. Magnetic resonance imaging analysis of percutaneous discectomy. A preliminary report. Spine (Phila Pa 1976). 1993 Feb;18(2):211-7.
• Cristante AF, Rocha ID, MartusMarcon R, Filho TE. Randomized clinical trial comparing lumbar percutaneous hydrodiscectomy with lumbar open microdiscectomy for the treatment of lumbar disc protrusions and herniations. Clinics (Sao Paulo). 2016 May;71(5):276-80. doi: 10.6061/clinics/2016(05)06.
• Rocha ID, Cristante AF, Marcon RM, Oliveira RP, Letaif OB, Barros Filho TE. Controlled medial branch anesthetic block in the diagnosis of chronic lumbar facet joint pain: the value of a three-month follow-up. Clinics (Sao Paulo). 2014 Aug;69(8):529-34. doi: 10.6061/clinics/2014(08)05.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: low back pain; spine surgery; herniated disk
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: SpJet2011; IOT (Other Identifier: iot 803 [institutional research committee])