NCT04254757

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

January 15, 2020

Last Update Submit

January 31, 2020

Conditions

Lumbar Spinal StenosisSurgery

Outcome Measures

Primary Outcomes (3)

  • Modified MacNab criteria

    1 years after surgery

  • Visual Analog Scale (VAS)

    VAS of leg and back

    at 1 years after surgery

  • Oswestry Disability Index(ODI)

    at 1 years after surgery

Secondary Outcomes (2)

  • Range of motion(ROM)

    at 1 years after surgery

  • Adjacent Segment Disease

    at 1 years after surgery

Study Arms (2)

Percutaneous endoscopic surgery group

OTHER
Procedure: Two different treatment

Open decompression and fusion surgery group

OTHER
Procedure: Two different treatment

Interventions

Two different treatmentPROCEDURE

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

Open decompression and fusion surgery groupPercutaneous endoscopic surgery group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35624443DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Xiaoguang Liu, M.D.,Ph.D.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Zhu, M.D

CONTACT

15201278112liuxgspine@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PH.D.,M.D.,Professor

Study Record Dates

First Submitted

January 15, 2020

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2023

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)