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Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04254757
Enrollment
600
Registered
2020-02-05
Start date
2020-02-01
Completion date
2023-12-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis, Surgery

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.

Interventions

PROCEDURETwo different treatment

One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery

Sponsors

Beijing Shijitan Hospital, Capital Medical University
CollaboratorOTHER
Xuanwu Hospital, Beijing
CollaboratorOTHER
Beijing Changping Hospital
CollaboratorUNKNOWN
Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Modified MacNab criteria1 years after surgery
Visual Analog Scale (VAS)at 1 years after surgeryVAS of leg and back
Oswestry Disability Index(ODI)at 1 years after surgery

Secondary

MeasureTime frameDescription
Range of motion(ROM)at 1 years after surgeryROM of operated level
Adjacent Segment Diseaseat 1 years after surgeryMeasured on CT and MRI

Countries

China

Contacts

Primary ContactBin Zhu, M.D
liuxgspine@126.com15201278112

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026