Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy
NCT ID: NCT02025283
Last Updated: 2014-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
73 participants
OBSERVATIONAL
2010-01-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group Decompression
Group Decompression: Patients assigned to Group Decompression. After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc. Then site verification was done again with water soluble contrast material under floroscopy guidance. Then flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) were advanced inside the trochar needle towards the disc and decompression was performed. After being sure of achieving sufficient decompression inside the disc, the decompression device were removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours.
Group Decompression or Group Nucleoplasty
Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM \[ArthroCare Spine, Sunnyvale, CA\]
Group Nucleoplasty
Group Nucleoplasty : Patients assigned to Group Nucleoplasty. After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc. Then site verification was done again with water soluble contrast material under floroscopy guidance. Then radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM \[ArthroCare Spine, Sunnyvale, CA\] were advanced inside the trochar needle towards the disc and nucleoplasty was performed. After being sure of achieving sufficient decompression inside the disc, the nucleoplasty probe was removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours.
Group Decompression or Group Nucleoplasty
Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM \[ArthroCare Spine, Sunnyvale, CA\]
Interventions
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Group Decompression or Group Nucleoplasty
Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith \& Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM \[ArthroCare Spine, Sunnyvale, CA\]
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
35 Years
60 Years
ALL
No
Sponsors
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Ankara University
OTHER
Responsible Party
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Barıs Adaklı
Specialist
Principal Investigators
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Barış Adaklı, Specialist
Role: PRINCIPAL_INVESTIGATOR
Ankara University
Locations
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Ankara University Medical School Algology Department
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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10-402-13
Identifier Type: -
Identifier Source: org_study_id
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