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N/A N=40 Randomized Single-blind Treatment

Percutaneous Diskectomy SpineJet x Open Microdiskectomy in Treatment of Lumbar Radiculopathy

Radiculopathy · Herniated Disk

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: VAS for Lumbar Pain in 3 Months — 2.63; 4.53 units on a scale — p=0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Open microdiscectomy (Procedure); Percutaneous Diskectomy SpineJet (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Sao Paulo
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
VAS for Lumbar Pain in 3 Months
2.63; 4.53 0.05
PRIMARY
Oswestry Disability Index (ODI) - 3th Month
17.05; 16.85 <0.05 sig
SECONDARY
Clinical Evaluation
1; 1; 3; 4; 2; 1 <0.05 sig
SECONDARY
VAS for Lumbar - 1st Week
3.71; 4.1 <0.05 sig
SECONDARY
VAS for Lumbar 1st Month
3.34; 4.06 <0.05 sig
SECONDARY
VAS for Lumbar Pain - 3rd Month
2.63; 4.53
SECONDARY
VAS for Lumbar Pain - 6th Month
3.5; 3.79 <0.05 sig
SECONDARY
VAS for Lumbar Pain - 12th Month
4.06; 3.03 <0.05 sig
SECONDARY
Oswestry Disability Index (ODI) - 1st Week
23.25; 20 <0.05 sig
SECONDARY
Oswestry Disability Index (ODI) - 1st Month
19.25; 10.78 <0.05 sig
SECONDARY
Oswestry Disability Index (ODI) - 6th Month
15.37; 15.1 <0.05 sig
SECONDARY
Oswestry Disability Index (ODI) - 12th Month
11; 12.7 <0.05 sig
SECONDARY
VAS for Leg Pain - 1st Week
4.3; 2.61 <0.05 sig
SECONDARY
VAS for Leg Pain - 1st Month
2.96; 2.76 <0.05 sig
SECONDARY
VAS for Leg Pain - 3rd Month
17.05; 16.85 <0.05 sig
SECONDARY
VAS for Leg Pain - 6rd Month
2.84; 2.88 <0.05 sig
SECONDARY
VAS for Leg Pain - 12th Month
3.37; 2.67 <0.05 sig

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.

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01367860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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