Clinical trial NCT05033457: Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis
Official title: Comparative Study Between Unilateral Biportal Endoscopy Technique and Percutaneous Endoscopic Transforaminal Discectomy for the Treatment of Lumbar Spinal Canal Stenosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lumbar Disc Herniation
Lead sponsor: Shaanxi Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Cross-sectional area of the preoperative lumbar intervertebral disc
timeFrame: preoperative
measure: Cross-sectional area of the preoperative spinal canal
timeFrame: preoperative
measure: Cross-sectional area of the postoperative lumbar intervertebral disc
timeFrame: 3 months after surgery
measure: preoperative ODI
timeFrame: preoperative
measure: ODI on 3 months after operation
timeFrame: 3 months after surgery
measure: ODI at the final follow-up
timeFrame: Final follow-up
measure: preoperative VAS back pain score
timeFrame: preoperative
measure: preoperative VAS leg pain score
timeFrame: preoperative
measure: VAS back pain score on postoperative day 1
timeFrame: 1 day after operation
measure: VAS leg pain score on postoperative day 1
timeFrame: 1 day after operation
measure: VAS back pain score on 3 months after operation
timeFrame: 3 months after operation
measure: VAS leg pain score on 3 months after operation
timeFrame: 3 months after operation
measure: VAS back pain score at the final follow-up
timeFrame: Final follow-up
measure: VAS leg pain score at the final follow-up
timeFrame: Final follow-up
Secondary outcomes:
measure: operation time
timeFrame: intraoperative
measure: incision size
timeFrame: intraoperative
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Shanxi Medical University
name: Jingpeng Wei
role: STUDY_CHAIR
References: