Lumbar Spinal StenosisNCT06365229
Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol
An observational study of Lumbar Spinal Stenosis, run by Beijing Friendship Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective, Non-randomized Cohort Trial 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).
- Conditions
- Lumbar Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| UBE Group | Patients with LSS undergoing UBE | |
| UE Group | Patients with LSS undergoing UE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
0-100%, the higher the score, the more severe the lumbar spine dysfunction
Measured: From enrollment to the end of follow-up at 1 year
Secondary outcomes (24)
Magnetic resonance imaging (MRI)
Enlargement ratio of the dural sac
Measured: From enrollment to the follow-up at 2 weeks
Computed tomography (CT) scans
bony decompression range; preservation rate of the facet joint
Measured: From enrollment to the end of follow-up at 2 weeks
Creatine kinase (CK)
Measured: From enrollment to the end of follow-up at 2 weeks
Erythrocyte sedimentation rate (ESR)
Measured: From enrollment to the follow-up at 2 weeks
Surgical complication
Adverse events will be recorded to assess the safety of decompression using UBE or UE for LSS.
Measured: From enrollment to the end of follow-up at 1 year
VAS (visual analogue scale) for leg pain
0-10, the higher the score, the more severe the pain
Measured: From enrollment to the end of follow-up at 1 year
VAS (visual analogue scale) for lower back pain
0-10, the higher the score, the more severe the pain
Measured: From enrollment to the end of follow-up at 1 year
Japanese Orthopaedic Association (JOA) score
0-29, the higher the score, the better the lumbar spine function
Measured: From enrollment to the end of follow-up at 1 year
Modified MacNab criteria
According to satisfaction, it is divided into four levels: excellent, good, acceptable, and poorexcellent, good, fair, and poor
Measured: From enrollment to the end of follow-up at 1 year
Operation time
Measured: Immediately after the surgery
Blood loss
Measured: Immediately after the surgery
Postoperative hospital stays
Measured: Immediately after the discharge
Age
Measured: Baseline, pre-surgery
Gender
Measured: Baseline, pre-surgery
Body mass index (BMI)
Measured: Baseline, pre-surgery
Medical comorbidity
Measured: Baseline, pre-surgery
Smoking status
Measured: Baseline, pre-surgery
Alcohol status
Measured: Baseline, pre-surgery
Symptoms duration
Measured: Baseline, pre-surgery
Physical examination finding
Measured: Baseline, pre-surgery
Previous spinal surgery
Measured: Baseline, pre-surgery
Affected level
Measured: Baseline, pre-surgery
Stenosis grade
Measured: Baseline, pre-surgery
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
Measured: From enrollment to the end of follow-up at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365229
- Sponsor's protocol ID
- 2022-P2-336-02
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective, Non-randomized Cohort Trial Protocol
- ClinicalTrials.gov ID
- NCT06365229
- Acronym / sponsor ID
- 2022-P2-336-02
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBE Group | – | –Patients with LSS undergoing UBE |
| UE Group | – | –Patients with LSS undergoing UE |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
24 secondary outcomes
Magnetic resonance imaging (MRI)
Time frame: From enrollment to the follow-up at 2 weeks
Computed tomography (CT) scans
Time frame: From enrollment to the end of follow-up at 2 weeks
Creatine kinase (CK)
Time frame: From enrollment to the end of follow-up at 2 weeks
Erythrocyte sedimentation rate (ESR)
Time frame: From enrollment to the follow-up at 2 weeks
Surgical complication
Time frame: From enrollment to the end of follow-up at 1 year
VAS (visual analogue scale) for leg pain
Time frame: From enrollment to the end of follow-up at 1 year
VAS (visual analogue scale) for lower back pain
Time frame: From enrollment to the end of follow-up at 1 year
Japanese Orthopaedic Association (JOA) score
Time frame: From enrollment to the end of follow-up at 1 year
Modified MacNab criteria
Time frame: From enrollment to the end of follow-up at 1 year
Operation time
Time frame: Immediately after the surgery
Blood loss
Time frame: Immediately after the surgery
Postoperative hospital stays
Time frame: Immediately after the discharge
Age
Time frame: Baseline, pre-surgery
Gender
Time frame: Baseline, pre-surgery
Body mass index (BMI)
Time frame: Baseline, pre-surgery
Medical comorbidity
Time frame: Baseline, pre-surgery
Smoking status
Time frame: Baseline, pre-surgery
Alcohol status
Time frame: Baseline, pre-surgery
Symptoms duration
Time frame: Baseline, pre-surgery
Physical examination finding
Time frame: Baseline, pre-surgery
Previous spinal surgery
Time frame: Baseline, pre-surgery
Affected level
Time frame: Baseline, pre-surgery
Stenosis grade
Time frame: Baseline, pre-surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 40713043Tan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: From enrollment to the end of follow-up at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06365229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.