RadiculopathyPDOP_TLRNCT01367860
Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy
A study testing Open microdiscectomy and Percutaneous Diskectomy SpineJet in people with Radiculopathy and Herniated Disk, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Radiculopathy, Herniated Disk
- What is being tested?
- Open microdiscectomy and Percutaneous Diskectomy SpineJet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Infection at the insertion of the device
- Pregnancy
- Any illness or medications that contraindicate surgical treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Orthopedics and Traumatology of the USP
São Paulo, São Paulo, 05403-010
About this study
Official title: 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.
Read more
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
- Being tested
- Open microdiscectomy, Percutaneous Diskectomy SpineJet
- Keywords
- spine surgery, low back pain, herniated disk
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open microdiscectomyProcedure or surgery
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 SpineJetProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| OMicro | Active comparator | This group will be formed by randomization, which gets out surgery to open microdiscectomy Receives: 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 Receives: Procedure: Percutaneous Diskectomy SpineJet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3th month
Secondary outcomes (15)
Clinical Evaluation
Will be measured dichotomously: (present or absent)
Variables:
Infection; residual pain; herniation recurrency
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6th month from surgery
VAS for Leg Pain - 12th Month
pain scale - VAS for leg pain - 12th month
Measured: 12th month from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre F. Cristante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367860
- Sponsor's protocol ID
- SpJet2011
- Other IDs
- IOT
- Acronym
- PDOP_TLR
- Status last verified
- May 2014
- First submitted
- 31 May 2011
- Last updated
- 4 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
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.
PubMed 17352640Davis GW, Onik G. Clinical experience with automated percutaneous lumbar discectomy. Clin Orthop Relat Res. 1989 Jan;(238):98-103.
PubMed 2521319Mochida 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.
PubMed 11380118Choy 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.
PubMed 10150569Wang 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.
PubMed 10101821Pauza 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.
PubMed 14749191Casey 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.
PubMed 9276049Delamarter 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.
PubMed 7713975Tonami 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.
PubMed 9413969Krugluger J, Knahr K. Chemonucleolysis and automated percutaneous discectomy--a prospective randomized comparison. Int Orthop. 2000;24(3):167-9. doi: 10.1007/s002640000139.
PubMed 10990391Vigatto 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.
PubMed 17304141Dullerud R, Nakstad PH. Side effects and complications of automated percutaneous lumbar nucleotomy. Neuroradiology. 1997 Apr;39(4):282-5. doi: 10.1007/s002340050410.
PubMed 9144678Wittenberg 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.
PubMed 11568690Slotman 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.
PubMed 9820717
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Percutaneous Diskectomy SpineJet x Open Microdiscectomy for Treatment of Lumbar Radiculopathy in Contained Disc Herniation: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01367860
- Acronym / sponsor ID
- PDOP_TLR / SpJet2011
- Conditions
- Radiculopathy, Herniated Disk
- Keywords
- spine surgery, low back pain, herniated disk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMicro | Active comparator | Procedure: Open microdiscectomyThis group will be formed by randomization, which gets out surgery to open microdiscectomy |
| SJet | Experimental | Procedure: Percutaneous Diskectomy SpineJetThis group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open microdiscectomyThe 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. | Procedure or surgery | OMicro |
| Percutaneous Diskectomy SpineJetPercutaneous 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. | Procedure or surgery | SJet |
Primary outcome
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.
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.
15 secondary outcomes
Clinical Evaluation
Time frame: 6th month
VAS for Lumbar - 1st Week
Time frame: 1st week from surgery
VAS for Lumbar 1st Month
Time frame: 1st month from surgery
VAS for Lumbar Pain - 3rd Month
Time frame: 3rd month from surgery
VAS for Lumbar Pain - 6th Month
Time frame: 6th month from surgery
VAS for Lumbar Pain - 12th Month
Time frame: 12th month from surgery
Oswestry Disability Index (ODI) - 1st Week
Time frame: 1st week minus baseline
Oswestry Disability Index (ODI) - 1st Month
Time frame: 1st month from baseline
Oswestry Disability Index (ODI) - 6th Month
Time frame: 6th month from surgery
Oswestry Disability Index (ODI) - 12th Month
Time frame: 12th month from surgery
VAS for Leg Pain - 1st Week
Time frame: 1st week from surgery
VAS for Leg Pain - 1st Month
Time frame: 1st month from surgery
VAS for Leg Pain - 3rd Month
Time frame: 3rd month from surgery
VAS for Leg Pain - 6rd Month
Time frame: 6th month from surgery
VAS for Leg Pain - 12th Month
Time frame: 12th month from surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundHijikata 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: PubMed 17352640Choy 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.
- Background: PubMed 2521319Davis GW, Onik G. Clinical experience with automated percutaneous lumbar discectomy. Clin Orthop Relat Res. 1989 Jan;(238):98-103.
- Background: PubMed 11380118Mochida 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.
- Background: PubMed 10150569Choy 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.
- Background: PubMed 10101821Wang 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.
- Background: PubMed 14749191Pauza 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.
- Background: PubMed 9276049Casey 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.
- Background: PubMed 7713975Delamarter 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.
- Background: PubMed 9413969Tonami 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.
- Background: PubMed 10990391Krugluger J, Knahr K. Chemonucleolysis and automated percutaneous discectomy--a prospective randomized comparison. Int Orthop. 2000;24(3):167-9. doi: 10.1007/s002640000139.
- Background: PubMed 17304141Vigatto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open microdiscectomy and Percutaneous Diskectomy SpineJet in people with Radiculopathy and Herniated Disk, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS for Lumbar Pain in 3 Months (time frame: VAS for Lumbar Pain at 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01367860, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.