Comparisons Therapeutic Effects of Different PELD Procedure on LSS.

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314453
• Other study ID #: SAHoWMU-CR2020-14-206
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degeneration Disc
• Intervertebral Disc Degeneration
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed by Visual Analogue Scale	Visual Analogue Scale (VAS 0 to 10)	Preoperation to postoperative 2 years.
Primary	Oswestry Disability Index (ODI)	the disability with ODI (0 to 100)	Preoperation to postoperative 2 years.
Secondary	minimum Dural sac cross sectional area (mDCSA)	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)	Baseline and postoperative 1-month