Comparisons Therapeutic Effects of Different PELD Procedure on LSS.

NCT ID: NCT04314453

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2017-12-31

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.

Conditions

Degeneration Disc; Lumbar Spinal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

T group

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

percutaneous endoscopic lumbar discectomy

Intervention Type: OTHER

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.

percutaneous endoscopic lumbar discectomy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

BINBIN WU

Attending Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SAHoWMU-CR2020-14-206

Identifier Type: -

Identifier Source: org_study_id