Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: Two different treatment

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bin Zhu, M.D; Phone Number: 15201278112; Email: liuxgspine@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Peking University Third Hospital
      • Contact: Bin Zhu, M.D.; Phone Number: 15201278112; Email: liuxgspine@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Percutaneous endoscopic surgery group	Procedure: Two different treatment; One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery
OTHER: Open decompression and fusion surgery group	Procedure: Two different treatment; One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion(ROM)	ROM of operated level	at 1 years after surgery
Adjacent Segment Disease	Measured on CT and MRI	at 1 years after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Xuanwu Hospital, Beijing; Beijing Shijitan Hospital, Capital Medical University; Beijing Changping Hospital
• Investigators: Principal Investigator: Xiaoguang Liu, M.D.,Ph.D., Peking University Third Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: BYSYZD2019001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No