Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy

Radiculopathy Clinical Trial

— PDOP_TLR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367860
• Other study ID #: SpJet2011
• Secondary ID: IOT
• Status: Completed
• Phase: N/A
• First received: May 31, 2011
• Last updated: May 19, 2014
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brasil: Institutional Review Board IOT USP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 76 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herniated Disk
• Radiculopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Institute of Orthopedics and Traumatology of the USP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

Choy DS, Hellinger J, Tassi GP, Hellinger S. Percutaneous laser disc decompression. Photomed Laser Surg. 2007 Feb;25(1):60. — View Citation

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. — View Citation

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

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. — View Citation

Dullerud R, Nakstad PH. Side effects and complications of automated percutaneous lumbar nucleotomy. Neuroradiology. 1997 Apr;39(4):282-5. — View Citation

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

Krugluger J, Knahr K. Chemonucleolysis and automated percutaneous discectomy--a prospective randomized comparison. Int Orthop. 2000;24(3):167-9. — View Citation

Matsui H, Aoki M, Kanamori M. Lateral disc herniation following percutaneous lumbar discectomy. A case report. Int Orthop. 1997;21(3):169-71. — View Citation

Mayer HM, Brock M. Percutaneous endoscopic discectomy: surgical technique and preliminary results compared to microsurgical discectomy. J Neurosurg. 1993 Feb;78(2):216-25. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Clinical Evaluation	Will be measured dichotomously: (present or absent); Variables: Infection; residual pain; herniation recurrency	6th month	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	VAS for Leg Pain - 12th Month	pain scale - VAS for leg pain - 12th month	12th month from surgery	No