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

NCT05033457 | Enrolling By Invitation

• 1 other identifier: sxsrmyyjzwc202101
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (2)

• operation time

  intraoperative

• incision size

  intraoperative

Study Arms (2)

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

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

Interventions

unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy PROCEDURE

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; unilateral biportal endoscopy technique group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Single-segment lumbar disc herniation/lumbar spinal stenosis

You may not qualify if:

• Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes
• Single-segment lumbar disc herniation Symptoms of nerve compression
• 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

Sponsors & Collaborators

• Shaanxi Provincial People's Hospital: lead

Study Sites (1)

Shanxi Medical University

Taiyuan, Shanxi, 030000, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jingpeng Wei

  Shanxi Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 2, 2021
• Study Start: January 1, 2018
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 2, 2021

Record last verified: 2021-01

Locations

CN (1)