Comparisons Therapeutic Effects of Different PELD Procedure on LSS.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04314453

Collaborator

(none)

140

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degeneration Disc Lumbar Spinal Stenosis	Other: percutaneous endoscopic lumbar discectomy

Study Design

Study Type:

Observational

Actual Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jul 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
T group The degenerative lumbar spinal stenosis patients accepted the PELD with TESSYS procedure.	Other: percutaneous endoscopic lumbar discectomy Resection of the hypertrophied faceted joints, osteophyte formation and ligamentum flavum (LF) hypertrophy, with or without disc protrusion for degenerative spinal stenosis.
U group The degenerative lumbar spinal stenosis patients accepted the PELD with U route procedure.	Other: percutaneous endoscopic lumbar discectomy Resection of the hypertrophied faceted joints, osteophyte formation and ligamentum flavum (LF) hypertrophy, with or without disc protrusion for degenerative spinal stenosis.

Arm

Intervention/Treatment

T group

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

Other: percutaneous endoscopic lumbar discectomy

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

U group

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

Other: percutaneous endoscopic lumbar discectomy

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

Outcome Measures

Primary Outcome Measures

Pain assessed by Visual Analogue Scale [Preoperation to postoperative 2 years.]
Visual Analogue Scale (VAS 0 to 10)
Oswestry Disability Index (ODI) [Preoperation to postoperative 2 years.]
the disability with ODI (0 to 100)

Secondary Outcome Measures

minimum Dural sac cross sectional area (mDCSA) [Baseline and postoperative 1-month]
the mDCSA at the most constricted lumbar spinal level of surgical intervertebral disc were measured for three times by the software of INFINITT Picture Archiving and Communication System (PACS) (INFINITT Healthcare Co., Seoul Korea)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.