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

Comparative Study Between Unilateral Biportal Endoscopy Technique and Percutaneous Endoscopic Transforaminal Discectomy for the Treatment of Lumbar Spinal Canal Stenosis

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with lumbar spinal stenosis, with low back pain and neurological urgency.The patient cannot relieve symptoms after 3 months or more of conservative treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
unilateral biportal endoscopy technique group; Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group	Procedure: 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.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group.
percutaneous endoscopic transforaminal discectomy group; Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group	Procedure: 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.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cross-sectional area of the preoperative lumbar intervertebral disc	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.	preoperative
Cross-sectional area of the preoperative spinal canal	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.	preoperative
Cross-sectional area of the postoperative lumbar intervertebral disc	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.	3 months after surgery
preoperative ODI	According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.	preoperative
ODI on 3 months after operation	According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.	3 months after surgery
ODI at the final follow-up	According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.	Final follow-up
preoperative VAS back pain score	According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.	preoperative
preoperative VAS leg pain score	According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.	preoperative
VAS back pain score on postoperative day 1	According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on postoperative day 1.	1 day after operation
VAS leg pain score on postoperative day 1	According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on postoperative day 1.	1 day after operation
VAS back pain score on 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.	3 months after operation
VAS leg pain score on 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.	3 months after operation
VAS back pain score at the 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.	Final follow-up
VAS leg pain score at the 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.	Final follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	Collect the operation time of participants during the operation.	intraoperative
incision size	Collect the incision size of participants during the operation.	intraoperative

Collaborators and Investigators

• Sponsor: Shaanxi Provincial People's Hospital
• Investigators: Study Chair: Jingpeng Wei, Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): January 1, 2028
• Study Completion (Anticipated): January 1, 2028

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Spinal Stenosis
• Other Study ID Numbers: sxsrmyyjzwc202101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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