Clinical trial NCT04254757: Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis
Official title: Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenosis
Surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Shijitan Hospital, Capital Medical University
name: Xuanwu Hospital, Beijing
name: Beijing Changping Hospital
First posted: 2020-02-05
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Modified MacNab criteria
timeFrame: 1 years after surgery
measure: Visual Analog Scale (VAS)
timeFrame: at 1 years after surgery
measure: Oswestry Disability Index(ODI)
timeFrame: at 1 years after surgery
Secondary outcomes:
measure: Range of motion(ROM)
timeFrame: at 1 years after surgery
measure: Adjacent Segment Disease
timeFrame: at 1 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Xiaoguang Liu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.