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Comparisons Therapeutic Effects of Different PELD Procedure on LSS.

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ClinicalTrials.gov Identifier: NCT04314453
Recruitment Status : Completed
First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
BINBIN WU, 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.

Condition or disease Intervention/treatment
Degeneration Disc Lumbar Spinal Stenosis Other: percutaneous endoscopic lumbar discectomy

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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 : January 1, 2014
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Pain assessed by Visual Analogue Scale [ Time Frame: Preoperation to postoperative 2 years. ]
    Visual Analogue Scale (VAS 0 to 10)

  2. Oswestry Disability Index (ODI) [ Time Frame: Preoperation to postoperative 2 years. ]
    the disability with ODI (0 to 100)


Secondary Outcome Measures :
  1. minimum Dural sac cross sectional area (mDCSA) [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
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Responsible Party: BINBIN WU, Attending Doctor, Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04314453    
Other Study ID Numbers: SAHoWMU-CR2020-14-206
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BINBIN WU, Second Affiliated Hospital of Wenzhou Medical University:
percutaneous endoscopic lumbar discectomy
minimally invasive
transforaminal endoscopic spine system
U route
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases