Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy

• Registration Number: NCT05033457
• Lead Sponsor: Shaanxi Provincial People's Hospital

Brief Summary

OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD.

METHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.

Detailed Description

It was performed as a retrospective analysis of prospectively collected data on patients received spinal endoscopic decompression between July 2020 to December 2020 was conducted. All patients underwent lumbar MRI examination with the result of L5-S1 disc herniation，accompanied by claudication or lower extremity radiation pain and other nerve compression symptoms. The symptoms have not improved with conservative treatments including physical therapy, medication, and epidural injection procedures for a minimum of 12 weeks. Patients who hadprevious spine surgery, infection, trauma, tumors or spondylolisthesis were excluded. The surgery was performed by the same experienced spinal surgeon and the surgical patient were closely followed for 3 months after surgery.

The investigators performed two kinds of endoscopic lumbar discectomy：unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD).

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2021-01
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-27
• Last Update Submitted: 2021-08-27
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Single-segment lumbar disc herniation/lumbar spinal stenosis

Exclusion Criteria

• Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes

Inclusion Criteria:

Inclusion Criteria:

Single-segment lumbar disc herniation Symptoms of nerve compression

Exclusion Criteria:

foraminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
unilateral biportal endoscopy technique group	unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy	Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group
percutaneous endoscopic transforaminal discectomy group	unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy	Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group

Primary Outcome Measures

Name	Time	Method
Cross-sectional area of the preoperative lumbar intervertebral disc	preoperative	The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
Cross-sectional area of the preoperative spinal canal	preoperative	The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the spinal canal of the diseased segment.
Cross-sectional area of the postoperative lumbar intervertebral disc	3 months after surgery	The postoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
preoperative ODI	preoperative	According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.
preoperative VAS back pain score	preoperative	According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.
preoperative VAS leg pain score	preoperative	According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.
VAS back pain score on 3 months after operation	3 months after operation	According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on 3 months after operation.
VAS leg pain score on 3 months after operation	3 months after operation	According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on 3 months after operation.
VAS back pain score at the final follow-up	Final follow-up	According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants at the final follow-up.
VAS leg pain score at the final follow-up	Final follow-up	According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants at the final follow-up.
ODI on 3 months after operation	3 months after surgery	According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.
ODI at the final follow-up	Final follow-up	According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.
VAS back pain score on postoperative day 1	1 day after operation	According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on postoperative day 1.
VAS leg pain score on postoperative day 1	1 day after operation	According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on postoperative day 1.

Secondary Outcome Measures

Name	Time	Method
operation time	intraoperative	Collect the operation time of participants during the operation.
incision size	intraoperative	Collect the incision size of participants during the operation.

Trial Locations

Locations (1)

Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China