Lumbar Degenerative SpondylolisthesisNCT07289737
Clinical Study on the Therapeutic Efficacy of Biportal Endoscopic Decompression Spine Surgery and Lumbar Decompression Fusion Surgery in the Treatment of Degenerative Lumbar Spondylolisthesis
An observational study of Lumbar Degenerative Spondylolisthesis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study aims to systematically evaluate the therapeutic efficacy of dual-channel endoscopic spinal decompression versus lumbar decompression with fusion for degenerative lumbar spondylolisthesis. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Lumbar Degenerative Spondylolisthesis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 30 Jun 2030
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lumbar degenerative spondylolisthesis
Who may be able to join
- Aged between 50 and 90 years old with a confirmed diagnosis of degenerative lumbar spondylolisthesis;
- Clinical symptoms include chronic pain, nerve compression, or motor dysfunction, confirmed by imaging studies (e.g., MRI or CT);
- No significant improvement after at least 3 months of conservative treatment (e.g., medication, physical therapy), meeting surgical indications;
- Understand and consent to the relevant procedures of this study, and sign the informed consent form.
Who cannot join
- Patients exhibiting acute spinal cord compression symptoms or requiring urgent surgical intervention;
- Patients with a history of spinal surgery or conditions such as spinal deformities, severe osteoporosis, or active infections that may compromise surgical outcomes;
- Patients with severe comorbidities affecting assessment, such as cardiovascular disease, liver or kidney failure, or uncontrolled diabetes;
- Patients with psychiatric disorders or cognitive impairments preventing understanding or cooperation with the study process;
- Patients with allergies to anesthetics or surgical equipment that may increase intraoperative risks.
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
4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, 322000
Shaohua Zhang, MD, +86 0579-89935052, jigoulunli_zy4y@163.com
About this study
This study aims to systematically evaluate the therapeutic efficacy of dual-channel endoscopic spinal decompression versus lumbar decompression with fusion for degenerative lumbar spondylolisthesis. Patients undergoing either procedure will undergo detailed preoperative and postoperative follow-up to compare outcomes between the two techniques, specifically assessing postoperative pain relief, neurological improvement, and the incidence of surgical complications.
Read the detailed description
- Screening and enrollment: This study is a prospective cohort study. Patients were screened based on inclusion and exclusion criteria. They were informed that surgical treatment for degenerative lumbar spondylolisthesis could involve either lumbar fusion surgery or dual-channel endoscopic decompression alone. Specific details of both procedures were explained, allowing patients to independently choose their surgical plan. Informed consent was obtained, and baseline data including symptoms, pain scores, and neurological function scores were collected. 2) Preoperative Assessment: All patients undergo detailed pain and neurological function evaluations prior to surgery. Pain intensity is quantified using the Visual Analogue Scale (VAS), while neurological function is assessed using systems such as the JOA score and ODI score. Imaging evaluations include MRI and CT scans. 3) Data Collection: Prospective data collection was conducted for both dual-channel endoscopic spinal decompression and lumbar decompression with fusion procedures. Surgical protocols were standardized, with documentation of operative images, procedure duration, blood loss, and intraoperative complications. Spinal vertebral and accessory tissue specimens were collected during surgery. 4) Postoperative Follow-up: Patients undergo follow-up at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months postoperatively. Repeat preoperative pain and neurological function assessments, conduct regular imaging reviews, and document postoperative recovery, complication rates, and recurrence. 5) Tissue Analysis: Specimens obtained during surgery undergo histological sectioning, RT-qPCR, or Western Blot testing to analyze differences. 6) Data Analysis: Statistical software analyzes collected data to evaluate changes in pre- and postoperative pain scores, neurological function scores, and imaging outcomes. Significance testing compares the efficacy and safety of the two surgical approaches.
- Conditions
- Lumbar Degenerative Spondylolisthesis
- Keywords
- lumbar, ube, Lumbar Degenerative Spondylolisthesis
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 | Only decompression | |
| Fusion | Lumbar Spine Fusion Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Pain Score
Measured: 36 month
JOA score
Function Score
Measured: 36month
ODI
Function Score
Measured: 36month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289737
- Sponsor's protocol ID
- KY-2025-093
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Therapeutic Efficacy of Biportal Endoscopic Decompression Spine Surgery and Lumbar Decompression Fusion Surgery in the Treatment of Degenerative Lumbar Spondylolisthesis
- ClinicalTrials.gov ID
- NCT07289737
- Acronym / sponsor ID
- KY-2025-093
- Conditions
- Lumbar Degenerative Spondylolisthesis
- Keywords
- lumbar, ube, Lumbar Degenerative Spondylolisthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 17 Dec 2025 (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.
This study aims to systematically evaluate the therapeutic efficacy of dual-channel endoscopic spinal decompression versus lumbar decompression with fusion for degenerative lumbar spondylolisthesis. Patients undergoing either procedure will undergo detailed preoperative and postoperative follow-up to compare outcomes between the two techniques, specifically assessing postoperative pain relief, neurological improvement, and the incidence of surgical complications.
Detailed description
- Screening and enrollment: This study is a prospective cohort study. Patients were screened based on inclusion and exclusion criteria. They were informed that surgical treatment for degenerative lumbar spondylolisthesis could involve either lumbar fusion surgery or dual-channel endoscopic decompression alone. Specific details of both procedures were explained, allowing patients to independently choose their surgical plan. Informed consent was obtained, and baseline data including symptoms, pain scores, and neurological function scores were collected. 2) Preoperative Assessment: All patients undergo detailed pain and neurological function evaluations prior to surgery. Pain intensity is quantified using the Visual Analogue Scale (VAS), while neurological function is assessed using systems such as the JOA score and ODI score. Imaging evaluations include MRI and CT scans. 3) Data Collection: Prospective data collection was conducted for both dual-channel endoscopic spinal decompression and lumbar decompression with fusion procedures. Surgical protocols were standardized, with documentation of operative images, procedure duration, blood loss, and intraoperative complications. Spinal vertebral and accessory tissue specimens were collected during surgery. 4) Postoperative Follow-up: Patients undergo follow-up at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months postoperatively. Repeat preoperative pain and neurological function assessments, conduct regular imaging reviews, and document postoperative recovery, complication rates, and recurrence. 5) Tissue Analysis: Specimens obtained during surgery undergo histological sectioning, RT-qPCR, or Western Blot testing to analyze differences. 6) Data Analysis: Statistical software analyzes collected data to evaluate changes in pre- and postoperative pain scores, neurological function scores, and imaging outcomes. Significance testing compares the efficacy and safety of the two surgical approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBE | – | –Only decompression |
| Fusion | – | –Lumbar Spine Fusion Surgery |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lumbar degenerative spondylolisthesis
Key inclusion criteria (4 listed)
- Aged between 50 and 90 years old with a confirmed diagnosis of degenerative lumbar spondylolisthesis;
- Clinical symptoms include chronic pain, nerve compression, or motor dysfunction, confirmed by imaging studies (e.g., MRI or CT);
- No significant improvement after at least 3 months of conservative treatment (e.g., medication, physical therapy), meeting surgical indications;
- Understand and consent to the relevant procedures of this study, and sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients exhibiting acute spinal cord compression symptoms or requiring urgent surgical intervention;
- Patients with a history of spinal surgery or conditions such as spinal deformities, severe osteoporosis, or active infections that may compromise surgical outcomes;
- Patients with severe comorbidities affecting assessment, such as cardiovascular disease, liver or kidney failure, or uncontrolled diabetes;
- Patients with psychiatric disorders or cognitive impairments preventing understanding or cooperation with the study process;
- Patients with allergies to anesthetics or surgical equipment that may increase intraoperative risks.
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
VAS
Time frame: 36 month
Pain Score
JOA score
Time frame: 36month
Function Score
ODI
Time frame: 36month
Function Score
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 17 Dec 2025.
- 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 Lumbar Degenerative Spondylolisthesis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 4 inclusion and 5 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 17 Dec 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 xue, MD (+86 057989935990, xuexiang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 36 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.