Trial Outcomes & Findings for Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy (NCT NCT01367860)

Last Updated: 2014-06-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

VAS for Lumbar Pain at 3 Months

Results posted on

2014-06-04

Participant Flow

Patients referred to our tertiary hospital for lumbar back pain were recruited. They were included in the study if they had disc protrusion or small herniation in only one level, with magnetic resonance imaging findings compatible with symptoms, without neurological deficits, and with no resolution after six weeks of conservative treatment.

Exclusion criteria were: neurological changes during conservative treatment, pregnancy, clinical status not adequate for surgical procedures, non-adherence to informed consent form. After inclusion in the study, patients were evaluated for pain and function and then randomly allocated in two groups

Participant milestones

Participant milestones
Measure	OMicro This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	41.2 years STANDARD_DEVIATION 9.3 • n=5 Participants	44.9 years STANDARD_DEVIATION 9.4 • n=7 Participants	43 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Schooling >=8 years	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Schooling <8 years	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Married Yes	18 participants n=5 Participants	13 participants n=7 Participants	31 participants n=5 Participants
Married No	2 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants
Manual labor yes	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants
Manual labor no	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Opioid use yes	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants
Opioid use no	7 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants
Working currently yes	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Working currently no	14 participants n=5 Participants	10 participants n=7 Participants	24 participants n=5 Participants
Receiving government benefit yes	13 participants n=5 Participants	10 participants n=7 Participants	23 participants n=5 Participants
Receiving government benefit no	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants
Months away from work	4.65 Months STANDARD_DEVIATION 6.52 • n=5 Participants	8.67 Months STANDARD_DEVIATION 14.4 • n=7 Participants	5.8 Months STANDARD_DEVIATION 9.14 • n=5 Participants
Months feeling pain	16.25 Months STANDARD_DEVIATION 20.2 • n=5 Participants	33.5 Months STANDARD_DEVIATION 47.3 • n=7 Participants	24.87 Months STANDARD_DEVIATION 36.96 • n=5 Participants
VAS for lumbar pain preoperatively	77.2 units on a scale STANDARD_DEVIATION 27 • n=5 Participants	63 units on a scale STANDARD_DEVIATION 30 • n=7 Participants	69.2 units on a scale STANDARD_DEVIATION 29 • n=5 Participants
VAS for leg pain preoperatively	84.2 units on a scale STANDARD_DEVIATION 23 • n=5 Participants	73.6 units on a scale STANDARD_DEVIATION 22 • n=7 Participants	78.9 units on a scale STANDARD_DEVIATION 22 • n=5 Participants
ODI preoperatively	33.65 units on a scale STANDARD_DEVIATION 9.33 • n=5 Participants	26.35 units on a scale STANDARD_DEVIATION 6.6 • n=7 Participants	30 units on a scale STANDARD_DEVIATION 8.8 • n=5 Participants

PRIMARY outcome

Timeframe: VAS for Lumbar Pain at 3 Months

Population: intention to treat

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Lumbar Pain in 3 Months	2.63 units on a scale Standard Deviation 2.9	4.53 units on a scale Standard Deviation 3.47

PRIMARY outcome

Timeframe: 3th month

Population: Intention to treat

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
Oswestry Disability Index (ODI) - 3th Month	17.05 units on a scale Standard Deviation 10.9	16.85 units on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: 6th month

Population: Infection

Will be measured dichotomously: (present or absent) Variables: Infection; residual pain; herniation recurrency

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
Clinical Evaluation Infection	1 participants	1 participants
Clinical Evaluation residual pain	3 participants	4 participants
Clinical Evaluation herniation recurrency	2 participants	1 participants

SECONDARY outcome

Timeframe: 1st week from surgery

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Lumbar - 1st Week	3.71 units on a scale Standard Deviation 2.76	4.1 units on a scale Standard Deviation 2.93

SECONDARY outcome

Timeframe: 1st month from surgery

Population: intention to treat

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Lumbar 1st Month	3.34 units on a scale Standard Error 2.92	4.06 units on a scale Standard Error 3.31

SECONDARY outcome

Timeframe: 3rd month from surgery

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Lumbar Pain - 3rd Month	2.63 units on a scale Standard Deviation 2.9	4.53 units on a scale Standard Deviation 3.47

SECONDARY outcome

Timeframe: 6th month from surgery

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Lumbar Pain - 6th Month	3.5 units on a scale Standard Deviation 3.54	3.79 units on a scale Standard Deviation 3.34

SECONDARY outcome

Timeframe: 12th month from surgery

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Lumbar Pain - 12th Month	4.06 units on a scale Standard Deviation 3.54	3.03 units on a scale Standard Deviation 3.32

SECONDARY outcome

Timeframe: 1st week minus baseline

Population: Intention to treat

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
Oswestry Disability Index (ODI) - 1st Week	23.25 units on a scale Standard Deviation 9.37	20 units on a scale Standard Deviation 8.13

SECONDARY outcome

Timeframe: 1st month from baseline

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
Oswestry Disability Index (ODI) - 1st Month	19.25 units on a scale Standard Deviation 10.23	10.78 units on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: 6th month from surgery

Population: Intention to treat

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
Oswestry Disability Index (ODI) - 6th Month	15.37 units on a scale Standard Deviation 11.45	15.1 units on a scale Standard Deviation 11.37

SECONDARY outcome

Timeframe: 12th month from surgery

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
Oswestry Disability Index (ODI) - 12th Month	11 units on a scale Standard Deviation 6.82	12.7 units on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 1st week from surgery

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Leg Pain - 1st Week	4.3 units on a scale Standard Deviation 2.92	2.61 units on a scale Standard Deviation 2.67

SECONDARY outcome

Timeframe: 1st month from surgery

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Leg Pain - 1st Month	2.96 units on a scale Standard Deviation 3.4	2.76 units on a scale Standard Deviation 3.41

SECONDARY outcome

Timeframe: 3rd month from surgery

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Leg Pain - 3rd Month	17.05 units on a scale Standard Deviation 10.9	16.85 units on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: 6th month from surgery

Population: Intention to treat

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.

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Leg Pain - 6rd Month	2.84 units on a scale Standard Deviation 3.82	2.88 units on a scale Standard Deviation 3.14

SECONDARY outcome

Timeframe: 12th month from surgery

pain scale - VAS for leg pain - 12th month

Outcome measures

Outcome measures
Measure	OMicro n=20 Participants This group will be formed by randomization, which gets out surgery to open microdiscectomy 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.	SJet n=20 Participants This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet 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.
VAS for Leg Pain - 12th Month	3.37 units on a scale Standard Deviation 3.8	2.67 units on a scale Standard Deviation 3.3

Adverse Events

OMicro

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SJet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexandre Cristante Fogaça

IOT/HC University of SãoPaulo

Phone: +55 11 2661-6951

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place