Lumbar Degenerative DiseaseNCT06506500
Unilateral Biportal Endoscopy Lumbar Interbody Fusion (ULIF) Versus Posterior Lumbar Interbody Fusion (PLIF) in Management of Single Level Lumbar Degenerative Disease: A Retrospective Study
An observational study of Lumbar Degenerative Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The study aimed to compare the clinical efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion (ULIF) with posterior lumbar interbody fusion (PLIF) in the treatment of single-level lumbar degenerative diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Degenerative Disease
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Patients who have been diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar spondylolisthesis. 2. The patient has clear indications for surgical treatment. 3. The patient is undergoing their initial single-segment ULIF or PLIF surgery at our hospital.
Who may be able to join
- Patients who have been diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar spondylolisthesis based on their medical history, physical signs, and imaging exams such as lumbar anteroposterior and lateral radiographs (including hyperextension and hyperflexion positions), lumbar CT, and lumbar MR. (2) The patient has clear indications for surgical treatment: ① Conservative treatment for more than three months has been ineffective or the symptoms have continued to worsen ② The patient's symptoms are severe and interfere with their daily work and life ③ The patient exhibits signs of cauda equina nerve compression (such as numbness in the perineal area, loss of bowel and bladder control, etc.).
- The patient is undergoing their initial single-segment ULIF or PLIF surgery at our hospital.
Who cannot join
- Patients with lumbar degenerative diseases involving two or more segments
- Pathological changes caused by other diseases, such as spinal infections, spinal trauma, spinal tumors, neurological diseases, etc.
- Patients with lumbar spondylolisthesis exceeding Meyerding Grade II or degenerative scoliosis with a Cobb angle greater than 20 degrees
- History of previous lumbar surgery
- History of previous tumor disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, 512000
About this study
The study aimed to compare the clinical efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion (ULIF) with posterior lumbar interbody fusion (PLIF) in the treatment of single-level lumbar degenerative diseases.
- Conditions
- Lumbar Degenerative Disease
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 |
|---|---|---|
| ULIF | Unilateral Biportal Endoscopy Lumbar Interbody Fusion | |
| PLIF | Posterior Lumbar Interbody Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI
Oswestry Disability Index
Measured: before surgery，1-week，1-month，3-month，6-month and 1-year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Nov 2022
- Primary completion1 Sep 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506500
- Sponsor's protocol ID
- SYSKY-2024-365-01
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Biportal Endoscopy Lumbar Interbody Fusion (ULIF) Versus Posterior Lumbar Interbody Fusion (PLIF) in Management of Single Level Lumbar Degenerative Disease: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06506500
- Acronym / sponsor ID
- SYSKY-2024-365-01
- Conditions
- Lumbar Degenerative Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 17 Jul 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.
The study aimed to compare the clinical efficacy and safety of unilateral biportal endoscopic lumbar interbody fusion (ULIF) with posterior lumbar interbody fusion (PLIF) in the treatment of single-level lumbar degenerative diseases.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ULIF | – | –Unilateral Biportal Endoscopy Lumbar Interbody Fusion |
| PLIF | – | –Posterior Lumbar Interbody Fusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Patients who have been diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar spondylolisthesis. 2. The patient has clear indications for surgical treatment. 3. The patient is undergoing their initial single-segment ULIF or PLIF surgery at our hospital.
Key inclusion criteria (2 listed)
- Patients who have been diagnosed with lumbar disc herniation, lumbar spinal stenosis, or lumbar spondylolisthesis based on their medical history, physical signs, and imaging exams such as lumbar anteroposterior and lateral radiographs (including hyperextension and hyperflexion positions), lumbar CT, and lumbar MR. (2) The patient has clear indications for surgical treatment: ① Conservative treatment for more than three months has been ineffective or the symptoms have continued to worsen ② The patient's symptoms are severe and interfere with their daily work and life ③ The patient exhibits signs of cauda equina nerve compression (such as numbness in the perineal area, loss of bowel and bladder control, etc.).
- The patient is undergoing their initial single-segment ULIF or PLIF surgery at our hospital.
Key exclusion criteria (5 listed)
- Patients with lumbar degenerative diseases involving two or more segments
- Pathological changes caused by other diseases, such as spinal infections, spinal trauma, spinal tumors, neurological diseases, etc.
- Patients with lumbar spondylolisthesis exceeding Meyerding Grade II or degenerative scoliosis with a Cobb angle greater than 20 degrees
- History of previous lumbar surgery
- History of previous tumor disease.
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
ODI
Time frame: before surgery，1-week，1-month，3-month，6-month and 1-year postoperative
Oswestry Disability Index
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 17 Jul 2024.
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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 Degenerative Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 2 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: finished, as of the sponsor's last update on 17 Jul 2024. 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?
ODI (time frame: before surgery，1-week，1-month，3-month，6-month and 1-year postoperative). 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 Jul 2024.