Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05033457

Comparative Study Between UBE and PETD 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanxi Medical University

Taiyuan, Shanxi, 030000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cross-sectional area of the preoperative lumbar intervertebral disc

    Time frame: 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.

  2. Cross-sectional area of the preoperative spinal canal

    Time frame: 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.

  3. Cross-sectional area of the postoperative lumbar intervertebral disc

    Time frame: 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.

  4. preoperative ODI

    Time frame: preoperative

    According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.

  5. ODI on 3 months after operation

    Time frame: 3 months after surgery

    According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.

  6. ODI at the final follow-up

    Time frame: Final follow-up

    According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.

  7. preoperative VAS back pain score

    Time frame: preoperative

    According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.

  8. preoperative VAS leg pain score

    Time frame: preoperative

    According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.

  9. VAS back pain score on postoperative day 1

    Time frame: 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.

  10. VAS leg pain score on postoperative day 1

    Time frame: 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.

  11. VAS back pain score on 3 months after operation

    Time frame: 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.

  12. VAS leg pain score on 3 months after operation

    Time frame: 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.

  13. VAS back pain score at the final follow-up

    Time frame: 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.

  14. VAS leg pain score at the final follow-up

    Time frame: 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.

Secondary outcomes

  1. operation time

    Time frame: intraoperative

    Collect the operation time of participants during the operation.

  2. incision size

    Time frame: intraoperative

    Collect the incision size of participants during the operation.

Sponsors and collaborators

Lead sponsor

Shaanxi Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Sep 2, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.