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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05033457
• Other study ID #: sxsrmyyjzwc202101
• Status: Enrolling by invitation
• Start date: January 1, 2018
• Est. completion date: January 1, 2028

Study information

• Verified date: January 2021
• Source: Shaanxi Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Disc Herniation
• Spinal Stenosis

Intervention

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.

Locations

Country	Name	City	State
China	Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shaanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	preoperative ODI	According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.	preoperative
Primary	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
Primary	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
Primary	preoperative VAS back pain score	According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.	preoperative
Primary	preoperative VAS leg pain score	According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.	preoperative
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	operation time	Collect the operation time of participants during the operation.	intraoperative
Secondary	incision size	Collect the incision size of participants during the operation.	intraoperative