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

Sponsors

Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Source Second Affiliated Hospital of Wenzhou Medical University
Brief 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.

Overall Status Completed
Start Date January 1, 2014
Completion Date December 31, 2017
Primary Completion Date July 31, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Pain assessed by Visual Analogue Scale Preoperation to postoperative 2 years.
Oswestry Disability Index (ODI) Preoperation to postoperative 2 years.
Secondary Outcome
Measure Time Frame
minimum Dural sac cross sectional area (mDCSA) Baseline and postoperative 1-month
Enrollment 140
Condition
Intervention

Intervention Type: Other

Intervention Name: percutaneous endoscopic lumbar discectomy

Description: Resection of the hypertrophied faceted joints, osteophyte formation and ligamentum flavum (LF) hypertrophy, with or without disc protrusion for degenerative spinal stenosis.

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- (1) patients with the diagnosis of degenerative lumbar spinal stenosis (LSS) (central stenosis with or without lateral recess stenosis) on mono or double segments, with the imaging evidence of magnetic resonance images (MRI) and computed tomography (CT); (2) patients presented low back pain, limp and sciatica, and have accepted conservative treatment more than 3 months but failed in symptoms relief; (3) patients agreed to accept TESSYS or the "U" route PELD procedure over other spinal surgeries; (4) patients had lumbar MRI imaging examines in our hospital at pre- and post-operation.

Exclusion Criteria:

- (1) patients with spinal instability, including dynamic instability or more than Grade II spondylolisthesis; (2) patients had spinal surgical history; (3) patients with peripheral nerve disease, systematic infection, bleeding diathesis or high risk of bleeding that cannot tolerate the surgery; (4) patients with mental illness and were uncooperative; (5) patients lost to the follow up.

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Second Affiliated Hospital of Wenzhou Medical University

Investigator Full Name: BINBIN WU

Investigator Title: Attending Doctor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: T group

Description: The degenerative lumbar spinal stenosis patients accepted the PELD with TESSYS procedure.

Label: U group

Description: The degenerative lumbar spinal stenosis patients accepted the PELD with U route procedure.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov