Comparisons of TESSYS and "U" Route Procedures of Transforaminal Percutaneous Endoscopic Lumbar Discectomy on Lumbar Spinal Stenosis Treatment
Sponsor study identifier
observational
140
0 countries
N/A
Study Start
January 1, 2014
Actual (reported)Primary Completion
July 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Different procedure of percutaneous endoscopic lumbar discectomy (PELD) was with ventral decompression of dural sac on the lumbar spinal stenosis remains unkonwn.The traditional transforaminal endoscopic spine system (TESSYS) of PELD has been used in clnical for many years, but cannot achieve dorsal decompression. A newly developed modified TESSYS procedure, "U" route PELD combining ventral and dorsal decompression was introduced. Nevertheless, the superior between TESSYS and "U" route PELD procedures on treating LSS remains unknown. This study is desinged to recruit degenerative lumbar spinal stenosis patients who underwent TESSYS or "U" rout PELD, recruited from January 2014 to December 2017. These patients will be followed up for 2 years, and assessed the minimum dura sac cross sectional area (mDCSA) by MRI, and visual analogue scale (VAS) and Oswestry Disability Index (ODI) at pre- and post-operation. The global clinical outcomes were evaluated using modified MacNab criteria postoperatively. Thus, comprehensively evaluate the safety and therapeutic effects of the two PELD procedures on LSS treatments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2014
Actual (reported)July 31, 2017
Actual (reported)December 31, 2017
Actual (reported)March 17, 2020
Actual (reported)March 19, 2020
Actual (reported)Pain assessed by Visual Analogue Scale
Visual Analogue Scale (VAS 0 to 10)
Preoperation to postoperative 2 years.
Oswestry Disability Index (ODI)
the disability with ODI (0 to 100)
Preoperation to postoperative 2 years.
minimum Dural sac cross sectional area (mDCSA)
Baseline and postoperative 1-month
The degenerative lumbar spinal stenosis patients accepted the PELD with TESSYS procedure.
The degenerative lumbar spinal stenosis patients accepted the PELD with U route procedure.
Resection of the hypertrophied faceted joints, osteophyte formation and ligamentum flavum (LF) hypertrophy, with or without disc protrusion for degenerative spinal stenosis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The degenerative lumbar spinal stenosis patients who underwent TESSYS or "U" rout PELD, recruited from January 2014 to December 2017.
140 participants (actual enrollment reported by the registry).
First Submitted
March 17, 2020
First Posted
March 19, 2020
Study Start
January 1, 2014
Actual (reported)Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Contact the study team to confirm eligibility.
Primary Completion
July 31, 2017
Actual (reported)Study Completion
December 31, 2017
Actual (reported)Last Updated
March 19, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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