Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy

NCT01367860 | Completed Results DMC

• 2 other identifiers: SpJet2011IOT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy; Herniated Disk

Keywords

spine surgery; low back pain; herniated disk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Clinical Evaluation

  6th month

• VAS for Lumbar - 1st Week

  1st week from surgery

• VAS for Lumbar 1st Month

  1st month from surgery

• VAS for Lumbar Pain - 3rd Month

  3rd month from surgery

• VAS for Lumbar Pain - 6th Month

  6th month from surgery

Study Arms (2)

OMicro

ACTIVE COMPARATOR

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

Procedure: Open microdiscectomy

SJet

EXPERIMENTAL

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

Procedure: Percutaneous Diskectomy SpineJet

Interventions

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.

OMicro

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.

SJet

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Orthopedics and Traumatology of the USP

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (22)

• 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

  BACKGROUND

• 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.

  PMID: 17352640 BACKGROUND

• Davis GW, Onik G. Clinical experience with automated percutaneous lumbar discectomy. Clin Orthop Relat Res. 1989 Jan;(238):98-103.

  PMID: 2521319 BACKGROUND

• 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.

  PMID: 11380118 BACKGROUND

• 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.

  PMID: 10150569 BACKGROUND

• 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.

  PMID: 10101821 BACKGROUND

• 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.

  PMID: 14749191 BACKGROUND

• 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.

  PMID: 9276049 BACKGROUND

• 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.

  PMID: 7713975 BACKGROUND

• 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.

  PMID: 9413969 BACKGROUND

• Krugluger J, Knahr K. Chemonucleolysis and automated percutaneous discectomy--a prospective randomized comparison. Int Orthop. 2000;24(3):167-9. doi: 10.1007/s002640000139.

  PMID: 10990391 BACKGROUND

• 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.

  PMID: 17304141 BACKGROUND

• Dullerud R, Nakstad PH. Side effects and complications of automated percutaneous lumbar nucleotomy. Neuroradiology. 1997 Apr;39(4):282-5. doi: 10.1007/s002340050410.

  PMID: 9144678 BACKGROUND

• 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.

  PMID: 11568690 BACKGROUND

• 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.

  PMID: 9820717 RESULT

• 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.

  PMID: 15752964 RESULT

• 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.

  PMID: 9266296 RESULT

• 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.

  PMID: 8267686 RESULT

• 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.

  PMID: 9152922 RESULT

• 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.

  PMID: 8441936 RESULT

• 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.

  PMID: 27276397 DERIVED

• 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.

  PMID: 25141111 DERIVED

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Displacement; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Alexandre Cristante Fogaça
• Organization: IOT/HC University of SãoPaulo

aacristante@uol.com.br

+55 11 2661-6951

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 7, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 4, 2014
• Results First Posted: June 4, 2014

Record last verified: 2014-05

Locations

BR (1)