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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05033457
Other study ID # sxsrmyyjzwc202101
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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