Clinical Trials Directory

Trials / Completed

CompletedNCT04314453

Comparisons Therapeutic Effects of Different PELD Procedure on LSS.

Comparisons of TESSYS and "U" Route Procedures of Transforaminal Percutaneous Endoscopic Lumbar Discectomy on Lumbar Spinal Stenosis Treatment

Status
Completed
Phase
Study type
Observational
Enrollment
140 (actual)
Sponsor
Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERpercutaneous endoscopic lumbar discectomyResection of the hypertrophied faceted joints, osteophyte formation and ligamentum flavum (LF) hypertrophy, with or without disc protrusion for degenerative spinal stenosis.

Timeline

Start date
2014-01-01
Primary completion
2017-07-31
Completion
2017-12-31
First posted
2020-03-19
Last updated
2020-03-19

Source: ClinicalTrials.gov record NCT04314453. Inclusion in this directory is not an endorsement.