Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis
Primary Purpose
Lumbar Spinal Stenosis, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Two different treatment
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis
Eligibility Criteria
Inclusion Criteria:
- Patients with symptomatic lumbar canal stenosis(including central canal, lateral recess, foraminal and extraforaminal) despite more than 6 weeks of conservative treatment; Pathology was confirmed by both computed tomography and magnetic resonance imaging The operative level≤2
Exclusion Criteria:
- Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection
Sites / Locations
- Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Percutaneous endoscopic surgery group
Open decompression and fusion surgery group
Arm Description
Outcomes
Primary Outcome Measures
Modified MacNab criteria
Visual Analog Scale (VAS)
VAS of leg and back
Oswestry Disability Index(ODI)
Secondary Outcome Measures
Range of motion(ROM)
ROM of operated level
Adjacent Segment Disease
Measured on CT and MRI
Full Information
NCT ID
NCT04254757
First Posted
January 15, 2020
Last Updated
January 31, 2020
Sponsor
Peking University Third Hospital
Collaborators
Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Beijing Changping Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04254757
Brief Title
Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis
Official Title
Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital
Collaborators
Beijing Shijitan Hospital, Capital Medical University, Xuanwu Hospital, Beijing, Beijing Changping Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Lumbar spinal stenosis (LSS) is the most common spinal degenerative disease. For conservative treatment failure, open lumbar decompression and fusion surgery is the main surgical treatment. After decades of development, open lumbar decompression and fusion surgery has been the standard treatment. However, there are still people and conditions that cannot be covered, such as elderly people who intolerable surgery, severe osteoporosis, and re-stenosis at adjacent segments after fusion. Percutaneous spinal endoscopic lumbar spinal decompression technique could be performed under local anesthesia, soft tissue damage is minimized, and effective spinal decompression can be achieved. There are still some controversial points of LSS decompression under percutaneous endoscope surgery, such as the range of decompression, choice of approach, postoperative spinal stability, learning curve, surgical safety, long-term effects of endoscopic treatment of restenosis at adjacent segments after fusion surgery. The purpose of this study was to solve these controversial points. A multi-center, prospective registration study based on the real world is planned. The total sample size is about 600 cases (300 cases in endoscopic surgery group, 300 cases in open decompression and fusion group). The mid- to long-term clinical efficacy and safety were evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous endoscopic surgery group
Arm Type
Other
Arm Title
Open decompression and fusion surgery group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Two different treatment
Intervention Description
One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery
Primary Outcome Measure Information:
Title
Modified MacNab criteria
Time Frame
1 years after surgery
Title
Visual Analog Scale (VAS)
Description
VAS of leg and back
Time Frame
at 1 years after surgery
Title
Oswestry Disability Index(ODI)
Time Frame
at 1 years after surgery
Secondary Outcome Measure Information:
Title
Range of motion(ROM)
Description
ROM of operated level
Time Frame
at 1 years after surgery
Title
Adjacent Segment Disease
Description
Measured on CT and MRI
Time Frame
at 1 years after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with symptomatic lumbar canal stenosis(including central canal, lateral recess, foraminal and extraforaminal) despite more than 6 weeks of conservative treatment; Pathology was confirmed by both computed tomography and magnetic resonance imaging The operative level≤2
Exclusion Criteria:
Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Zhu, M.D
Phone
15201278112
Email
liuxgspine@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoguang Liu, M.D.,Ph.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Zhu, M.D.
Phone
15201278112
Email
liuxgspine@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35624443
Citation
Zhai S, Zhao W, Zhu B, Huang X, Liang C, Hai B, Ding L, Zhu H, Wang X, Wei F, Chu H, Liu X. The effectiveness of percutaneous endoscopic decompression compared with open decompression and fusion for lumbar spinal stenosis: protocol for a multicenter, prospective, cohort study. BMC Musculoskelet Disord. 2022 May 27;23(1):502. doi: 10.1186/s12891-022-05440-4.
Results Reference
derived
Learn more about this trial
Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis
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