Degenerative SpondylolisthesisNCT06394089
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol
An observational study of Degenerative Spondylolisthesis and Lumbar Spinal Stenosis, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
A single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for lumbar spinal stenosis Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Degenerative Spondylolisthesis, Lumbar Spinal Stenosis
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 28 Feb 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients with LSS who are scheduled to undergo UBE-based decompression, performed by an experienced spine surgeon at Beijing Friendship Hospital, will be recruited from the outpatient clinic for this study.
Who may be able to join
- Age range: 50-80 years
- Diagnosis of LSS affecting 1-2 vertebral levels
- Predominant manifestation of neurogenic intermittent claudication, with ineffective conservative treatment for at least 3 months
- Presence of lumbar DS of less than grade II and absence of spine instability
- Willingness to participate in the study and complete follow-up assessments.
Who cannot join
- Diagnosis of isthmic lumbar spondylolisthesis or lumbar DS of grade ≥II
- Evidence of instability at the affected vertebral level (intervertebral angle change > 15° and/or vertebral translation ≥ 4.5 mm in standing flexion-extension radiographs of the lumbar spine)
- History of prior surgery at the affected vertebral level
- Presence of scoliosis with a Cobb angle >20º
- Presence of other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
- Medical disorders that preclude surgical tolerance
- Participation in other clinical research projects related to the treatment of lumbar spinal stenosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Yue Li, +86 10 6313 9006, 13661202501@163.com
Xiang Li
About this study
Official title: Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol
A single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for 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 |
|---|---|---|
| DS Group | Patients with degenerative spondylolisthesis Meyerding grade Ⅰ (slippage >3 mm but <25%) will be identified as having lumbar spinal stenosis combined with degenerative spondylolisthesis and will be allocated to the DS group. | |
| Non-DS Group | Patients not with degenerative spondylolisthesis will be identified as having lumbar spinal stenosis only and will be allocated to the Non-DS group. |
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 2 year
Secondary outcomes (21)
X-ray
Progression of lumbar spondylolisthesis, assessed by postoperative lumbar radiography; (2) Measurement of sagittal translation, segmental angulation, and posterior opening based on postoperative standing flexion-extension radiographs
Measured: From enrollment to the end of follow-up at 2 year
Computed tomography (CT) scan
Assessment of bone resection area and preservation rate of the facet joint using postoperative computed tomography (CT) scans
Measured: From enrollment to the end of follow-up at 2 year
Magnetic resonance imaging (MRI)
Calculation of the enlargement ratio of the dural sac based on postoperative magnetic resonance imaging (MRI)
Measured: From enrollment to the end of follow-up at 2 year
Surgical complication
Any adverse events will be recorded to evaluate the safety of decompression using UBE for LSS with or without DS
Measured: From enrollment to the end of follow-up at 2 year
Visual analog scale (VAS) score 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 2 year
Visual analog scale (VAS) score for leg pain
0-10, the higher the score, the more severe the pain
Measured: From enrollment to the end of follow-up at 2 year
Operative time
Time to perform the operation
Measured: Immediately after the surgery
Intraoperative blood loss
B、 Blood loss during the surgery
Measured: Immediately after the surgery
Postoperative hospital stays
Number of days in hospital after operation
Measured: Immediately after the discharge
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 2 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 2 year
Improvement ratio of Visual analog scale (VAS) score for lower back pain
Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms
Measured: From enrollment to the end of follow-up at 2 year
Improvement ratio of Visual analog scale (VAS) score for leg pain
Improvement ratio= (preoperative VAS-postoperative VAS/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of symptoms
Measured: From enrollment to the end of follow-up at 2 year
Improvement ratio of Japanese Orthopaedic Association (JOA) score
Improvement ratio= (postoperative JOA-preoperative JOA/preoperative VAS, ranging from 0-100%, the higher the score, the better the improment of spinal function
Measured: From enrollment to the end of follow-up at 2 year
Improvement ratio of Oswestry Disability Index (ODI)
Improvement ratio= (preoperative ODI-postoperative ODI)/preoperative ODI, ranging from 0-100%, the higher the score, the better the improment of symptoms
Measured: From enrollment to the end of follow-up at 2 year
White blood cell count
White blood cell count of venous blood
Measured: From enrollment to 3 days after surgery
Percentage of neutrophils (N%)
The proportion of neutrophils relative to the total white blood cell count
Measured: From enrollment to 3 days after surgery
C-reactive protein level
The level of C-reactive protein in blood
Measured: From enrollment to 3 days after surgery
Creatine kinase level
The level of creatine kinase in blood
Measured: From enrollment to 3 days after surgery
Lactate dehydrogenase level
The level of Lactate dehydrogenase in blood
Measured: From enrollment to 3 days after surgery
Myoglobin level
The level of myoglobin in blood
Measured: From enrollment to 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Mar 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
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 Degenerative SpondylolisthesisStudies 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
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394089
- Sponsor's protocol ID
- 2023-P2-293-01
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liu Y, Li G, Yu L, Sun H, Zhu B, Fei Q, Lo Y, Yang Y, Tan H, Li X. Degenerative spondylolisthesis and unilateral biportal endoscopic decompression for lumbar spinal stenosis: a single-center, prospective cohort trial protocol. BMC Musculoskelet Disord. 2025 Oct 1;26(1):900. doi: 10.1186/s12891-025-09179-6.
PubMed 41034885
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol
- ClinicalTrials.gov ID
- NCT06394089
- Acronym / sponsor ID
- 2023-P2-293-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 May 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 single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for lumbar spinal stenosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS Group | – | –Patients with degenerative spondylolisthesis Meyerding grade Ⅰ (slippage >3 mm but <25%) will be identified as having lumbar spinal stenosis combined with degenerative spondylolisthesis and will be allocated to the DS group. |
| Non-DS Group | – | –Patients not with degenerative spondylolisthesis will be identified as having lumbar spinal stenosis only and will be allocated to the Non-DS group. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients with LSS who are scheduled to undergo UBE-based decompression, performed by an experienced spine surgeon at Beijing Friendship Hospital, will be recruited from the outpatient clinic for this study.
Key inclusion criteria (5 listed)
- Age range: 50-80 years
- Diagnosis of LSS affecting 1-2 vertebral levels
- Predominant manifestation of neurogenic intermittent claudication, with ineffective conservative treatment for at least 3 months
- Presence of lumbar DS of less than grade II and absence of spine instability
- Willingness to participate in the study and complete follow-up assessments.
Key exclusion criteria (7 listed)
- Diagnosis of isthmic lumbar spondylolisthesis or lumbar DS of grade ≥II
- Evidence of instability at the affected vertebral level (intervertebral angle change > 15° and/or vertebral translation ≥ 4.5 mm in standing flexion-extension radiographs of the lumbar spine)
- History of prior surgery at the affected vertebral level
- Presence of scoliosis with a Cobb angle >20º
- Presence of 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 2 year
0-100%, the higher the score, the more severe the lumbar spine dysfunction
21 secondary outcomes
X-ray
Time frame: From enrollment to the end of follow-up at 2 year
Computed tomography (CT) scan
Time frame: From enrollment to the end of follow-up at 2 year
Magnetic resonance imaging (MRI)
Time frame: From enrollment to the end of follow-up at 2 year
Surgical complication
Time frame: From enrollment to the end of follow-up at 2 year
Visual analog scale (VAS) score for lower back pain
Time frame: From enrollment to the end of follow-up at 2 year
Visual analog scale (VAS) score for leg pain
Time frame: From enrollment to the end of follow-up at 2 year
Operative time
Time frame: Immediately after the surgery
Intraoperative blood loss
Time frame: Immediately after the surgery
Postoperative hospital stays
Time frame: Immediately after the discharge
Japanese Orthopaedic Association (JOA) score
Time frame: From enrollment to the end of follow-up at 2 year
Modified MacNab criteria
Time frame: From enrollment to the end of follow-up at 2 year
Improvement ratio of Visual analog scale (VAS) score for lower back pain
Time frame: From enrollment to the end of follow-up at 2 year
Improvement ratio of Visual analog scale (VAS) score for leg pain
Time frame: From enrollment to the end of follow-up at 2 year
Improvement ratio of Japanese Orthopaedic Association (JOA) score
Time frame: From enrollment to the end of follow-up at 2 year
Improvement ratio of Oswestry Disability Index (ODI)
Time frame: From enrollment to the end of follow-up at 2 year
White blood cell count
Time frame: From enrollment to 3 days after surgery
Percentage of neutrophils (N%)
Time frame: From enrollment to 3 days after surgery
C-reactive protein level
Time frame: From enrollment to 3 days after surgery
Creatine kinase level
Time frame: From enrollment to 3 days after surgery
Lactate dehydrogenase level
Time frame: From enrollment to 3 days after surgery
Myoglobin level
Time frame: From enrollment to 3 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 41034885Liu Y, Li G, Yu L, Sun H, Zhu B, Fei Q, Lo Y, Yang Y, Tan H, Li X. Degenerative spondylolisthesis and unilateral biportal endoscopic decompression for lumbar spinal stenosis: a single-center, prospective cohort trial protocol. BMC Musculoskelet Disord. 2025 Oct 1;26(1):900. doi: 10.1186/s12891-025-09179-6.
- 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.
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 Degenerative Spondylolisthesis and 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 7 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: looking for participants now, as of the sponsor's last update on 6 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Li (+86 10 6313 9155, muzixiangxin2022@163.com), or a site near the patient. 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 2 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 NCT06394089, 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 6 Jun 2025.