Comparisons Therapeutic Effects of Different PELD Procedure on LSS.

NCT04314453 | Completed

• 1 other identifier: SAHoWMU-CR2020-14-206
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Keywords

percutaneous endoscopic lumbar discectomy; minimally invasive; transforaminal endoscopic spine system; U route

Outcome Measures

Primary Outcomes (2)

• Pain assessed by Visual Analogue Scale

  Visual Analogue Scale (VAS 0 to 10)

  Preoperation to postoperative 2 years.

• Oswestry Disability Index (ODI)

  the disability with ODI (0 to 100)

  Preoperation to postoperative 2 years.

Secondary Outcomes (1)

• minimum Dural sac cross sectional area (mDCSA)

  Baseline and postoperative 1-month

Study Arms (2)

T group

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

Other: percutaneous endoscopic lumbar discectomy

U group

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

Other: percutaneous endoscopic lumbar discectomy

Interventions

percutaneous endoscopic lumbar discectomy OTHER

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

T group; U group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The degenerative lumbar spinal stenosis patients who underwent TESSYS or "U" rout PELD, recruited from January 2014 to December 2017.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: January 1, 2014
• Primary Completion: July 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share