Lumbar Spinal StenosisNCT04946487
Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery
An observational study of Lumbar Spinal Stenosis, run by Peking University Third Hospital.
Trial summary
To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF) Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- total laminectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 30 Dec 2022
- 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 25 to 75 years
- All sexes
- Adult, Older adult
Study population: From January 2010 to December 2014
Who may be able to join
- typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to ≥6 months of strict conservative treatment; and L5/S1 single-level PLIF with pedicle screw instrumentation.
Who cannot join
- previous spine surgery, acute spinal fracture, infection, and tumor.
Trial locations and contacts
No sites are listed yet.
About this study
To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)
Read the detailed description
Purpose: To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF).
Methods: This retrospective study was performed in patients who received L5/S1 PLIF with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. They were divided into the total laminectomy group, which had destruction of the PLC of the adjacent segment, or partial laminectomy group, which did not. Vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (LF) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (MRI). Disc degeneration and spinal stenosis on MRI scans were categorized. The incidence of ASD and clinical outcome were compared between the groups.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- total laminectomy
- Keywords
- Adjacent Segment Degeneration, lumbar posterior ligamentous complex, posterior lumbar interbody fusion
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total laminectomyProcedure or surgery
Total laminectomy removes the posterior ligamentous complex (PLC) at the fusion and superior levels.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | patients in this group destructed the posterior ligamentous complex of the adjacent segment Receives: Procedure: total laminectomy | |
| group 2 | patients in this group did not destruct the of the posterior ligamentous complex of the adjacent segment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Incidences of adjacent segment degeneration
the Incidences of adjacent segment degeneration
Measured: From the end of treatment to more than 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weishi Li, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946487
- Sponsor's protocol ID
- M2019232
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Posterior Ligamentous Complex on the Adjacent Segments Degeneration After Lumbar Surgery
- ClinicalTrials.gov ID
- NCT04946487
- Acronym / sponsor ID
- M2019232
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Adjacent Segment Degeneration, lumbar posterior ligamentous complex, posterior lumbar interbody fusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 30 Jun 2021 (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.
To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF)
Detailed description
Purpose: To investigate whether destroying the adjacent posterior ligamentous complex (PLC) has an effect on adjacent segment degeneration (ASD) after L5/S1 posterior lumbar interbody fusion (PLIF).
Methods: This retrospective study was performed in patients who received L5/S1 PLIF with pedicle screw instrumentation for lumbar spinal stenosis with or without isthmic spondylolisthesis. They were divided into the total laminectomy group, which had destruction of the PLC of the adjacent segment, or partial laminectomy group, which did not. Vertebral slip, osteophytes, disk height, and range of motion were examined by plain radiography, and thickness of the ligamentum flavum (LF) and anteroposterior diameters of the lumbar vertebral body and spinal canal were assessed by magnetic resonance imaging (MRI). Disc degeneration and spinal stenosis on MRI scans were categorized. The incidence of ASD and clinical outcome were compared between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: total laminectomypatients in this group destructed the posterior ligamentous complex of the adjacent segment |
| group 2 | – | –patients in this group did not destruct the of the posterior ligamentous complex of the adjacent segment |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- From January 2010 to December 2014
Key inclusion criteria (1 listed)
- typical clinical symptoms such as disabling low back or leg pain with or without neurological symptoms, intermittent claudication, with refractory to ≥6 months of strict conservative treatment; and L5/S1 single-level PLIF with pedicle screw instrumentation.
Key exclusion criteria (1 listed)
- previous spine surgery, acute spinal fracture, infection, and tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total laminectomyTotal laminectomy removes the posterior ligamentous complex (PLC) at the fusion and superior levels. | Procedure or surgery | group 1 |
Primary outcome
the Incidences of adjacent segment degeneration
Time frame: From the end of treatment to more than 8 years
the Incidences of adjacent segment degeneration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- 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.
Weishi Li principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Peking University Third Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuofu Li (15620610715, 840764209@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Incidences of adjacent segment degeneration (time frame: From the end of treatment to more than 8 years). 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 30 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.