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Completed

NCT Number: NCT06365229

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

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).

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Who can participate

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

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

  • 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

Treatment and study plan

Primary outcomes

  1. Oswestry Disability Index (ODI)

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

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

Secondary outcomes

  1. Magnetic resonance imaging (MRI)

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

    Enlargement ratio of the dural sac

  2. Computed tomography (CT) scans

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

    bony decompression range; preservation rate of the facet joint

  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

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

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

  6. VAS (visual analogue scale) for leg pain

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

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

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

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

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

  8. Japanese Orthopaedic Association (JOA) score

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

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

  9. Modified MacNab criteria

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

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

  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)

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

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

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective, Non-randomized Cohort Trial Protocol

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Jul 2, 2025

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.

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