CClinicalTrials.gg
CompletedNCT06365229Updated Jul 2, 2025

Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

An observational study in Lumbar Spinal Stenosis, sponsored by Beijing Friendship Hospital. Completed at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by Beijing Friendship Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
50 Years to 80 Years
Sex
All
01

Study summary

A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS).

02

Conditions studied

  • Lumbar Spinal Stenosis

Browse trials for

03

In context

Spinal Stenosis

459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.

This study's enrollment of 120 is close to the median of 116 across 152 observational studies indexed under Spinal Stenosis.

Browse Spinal Stenosis studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with LSS undergoing UBE or UE decompression performed by two experienced spine surgeons at the same hospital will be recruited for the study.

Inclusion criteria

  • Age range: 50-80 years
  • Diagnosed with LSS of 1-2 response levels
  • The predominant manifestation is neurogenic intermittent claudication, and conservative treatment has been ineffective for at least 3 months
  • Degenerative lumbar spondylolisthesis of less than I degree or without spine instability
  • Patients agree to participate in the study and are willing to complete the follow-up

Exclusion criteria

Exclusion Criteria:

  • Isthmic lumbar spondylolisthesis or degenerative lumbar spondylolisthesis of greater than I degree
  • Instability at the response level
  • Prior surgical history at the response level
  • Scoliosis with Cobb angle \>20 degrees
  • Other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
  • Patients with medical disorders who are unable to tolerate surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • UBE Group

    Patients with LSS undergoing UBE

  • UE Group

    Patients with LSS undergoing UE

06

What researchers measure

Primary outcomes

  1. Oswestry Disability Index (ODI)

    0-100%, the higher the score, the more severe the lumbar spine dysfunction

    Time frame: From enrollment to the end of follow-up at 1 year

Secondary outcomes

  1. Magnetic resonance imaging (MRI)

    Enlargement ratio of the dural sac

    Time frame: From enrollment to the follow-up at 2 weeks

  2. Computed tomography (CT) scans

    bony decompression range; preservation rate of the facet joint

    Time frame: From enrollment to the end of follow-up at 2 weeks

  3. Creatine kinase (CK)

    Time frame: From enrollment to the end of follow-up at 2 weeks

  4. Erythrocyte sedimentation rate (ESR)

    Time frame: From enrollment to the follow-up at 2 weeks

  5. Surgical complication

    Adverse events will be recorded to assess the safety of decompression using UBE or UE for LSS.

    Time frame: From enrollment to the end of follow-up at 1 year

  6. VAS (visual analogue scale) for leg pain

    0-10, the higher the score, the more severe the pain

    Time frame: From enrollment to the end of follow-up at 1 year

  7. VAS (visual analogue scale) for lower back pain

    0-10, the higher the score, the more severe the pain

    Time frame: From enrollment to the end of follow-up at 1 year

  8. Japanese Orthopaedic Association (JOA) score

    0-29, the higher the score, the better the lumbar spine function

    Time frame: From enrollment to the end of follow-up at 1 year

  9. Modified MacNab criteria

    According to satisfaction, it is divided into four levels: excellent, good, acceptable, and poorexcellent, good, fair, and poor

    Time frame: From enrollment to the end of follow-up at 1 year

  10. Operation time

    Time frame: Immediately after the surgery

  11. Blood loss

    Time frame: Immediately after the surgery

  12. Postoperative hospital stays

    Time frame: Immediately after the discharge

  13. Age

    Time frame: Baseline, pre-surgery

  14. Gender

    Time frame: Baseline, pre-surgery

  15. Body mass index (BMI)

    Time frame: Baseline, pre-surgery

  16. Medical comorbidity

    Time frame: Baseline, pre-surgery

  17. Smoking status

    Time frame: Baseline, pre-surgery

  18. Alcohol status

    Time frame: Baseline, pre-surgery

  19. Symptoms duration

    Time frame: Baseline, pre-surgery

  20. Physical examination finding

    Time frame: Baseline, pre-surgery

  21. Previous spinal surgery

    Time frame: Baseline, pre-surgery

  22. Affected level

    Time frame: Baseline, pre-surgery

  23. Stenosis grade

    Time frame: Baseline, pre-surgery

  24. Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

    range, 0-100 points, with higher scores indicating better physical health-related quality of life

    Time frame: From enrollment to the end of follow-up at 1 year

07

Study locations

1 site
  • Beijing Friendship Hospital
    Beijing, Beijing Municipality 100050, China
08

References and documents

Publications

  • Tan H, Liu Y, Li G, Yu L, Yang Y, Lo Y, Bin Z, Li X. Percutaneous unilateral biportal endoscopy versus uniportal endoscopy for lumbar spinal stenosis: a single-centre, prospective, non-randomised cohort trial protocol. BMJ Open. 2025 Jul 25;15(7):e087863. doi: 10.1136/bmjopen-2024-087863. PubMed 40713043 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06365229
Lead sponsor
Beijing Friendship Hospital
Responsible party
Sponsor
First posted
Apr 15, 2024
Start date
Jan 1, 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Jul 2, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion