Adjacent Segment DiseaseNCT04970862
Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration
An observational study of Adjacent Segment Disease and Adjacent Segment Degeneration, run by Peking University Third Hospital.
Trial summary
The purpose of this study was to investigate postoperative imaging changes and clinical symptom improvement in patients undergoing revision surgery for adjacent segment degeneration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adjacent Segment Disease, Adjacent Segment Degeneration
- What is being tested?
- reversion surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 30 Dec 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2010 to June 2018, patients with lumbar spine disease hospitalized in orthopedics were screened out to meet the criteria
Who may be able to join
- For patients undergoing revision surgery in adjacent segments due to S-ASD, the revision surgery is at least half a year from the first operation;
- X-ray, CT and MRI examination data of the anterior and lateral extension of the lumbar spine were available within 1 month before surgery and at the last follow-up;
- Follow-up for at least 2 years after revision;
Who cannot join
- Patients with history of congenital spinal deformity, spinal tumor, spinal tuberculosis.
Trial locations and contacts
No sites are listed yet.
Zhuofu Li, M.D. contact
About this study
The purpose of this study was to investigate postoperative imaging changes and clinical symptom improvement in patients undergoing revision surgery for adjacent segment degeneration.
- Being tested
- reversion surgery
- Keywords
- Adjacent Segment Degeneration, reversion surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reversion surgeryProcedure or surgery
reversion surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) scores of low back pain and leg pain
Visual Analog Scale (VAS) scores of low back pain and leg pain
Measured: 2 years after revision surgery
Japanese Orthopedic Association (JOA) score
Japanese Orthopedic Association (JOA) score
Measured: 2 years after revision surgery
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI)
Measured: 2 years after revision surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjacent Segment DiseaseStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weishi Li, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970862
- Sponsor's protocol ID
- M2020288
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Revision Surgery of Lumbar Adjacent Segment Degeneration
- ClinicalTrials.gov ID
- NCT04970862
- Acronym / sponsor ID
- M2020288
- Keywords
- Adjacent Segment Degeneration, reversion surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Jul 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.
The purpose of this study was to investigate postoperative imaging changes and clinical symptom improvement in patients undergoing revision surgery for adjacent segment degeneration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2010 to June 2018, patients with lumbar spine disease hospitalized in orthopedics were screened out to meet the criteria
Key inclusion criteria (3 listed)
- For patients undergoing revision surgery in adjacent segments due to S-ASD, the revision surgery is at least half a year from the first operation;
- X-ray, CT and MRI examination data of the anterior and lateral extension of the lumbar spine were available within 1 month before surgery and at the last follow-up;
- Follow-up for at least 2 years after revision;
Key exclusion criteria (1 listed)
- Patients with history of congenital spinal deformity, spinal tumor, spinal tuberculosis.
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 |
|---|---|---|
| reversion surgeryreversion surgery | Procedure or surgery | – |
Primary outcome
Visual Analog Scale (VAS) scores of low back pain and leg pain
Time frame: 2 years after revision surgery
Visual Analog Scale (VAS) scores of low back pain and leg pain
Japanese Orthopedic Association (JOA) score
Time frame: 2 years after revision surgery
Japanese Orthopedic Association (JOA) score
Oswestry Disability Index (ODI)
Time frame: 2 years after revision surgery
Oswestry Disability Index (ODI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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Adjacent Segment Disease
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.
Zhuofu Li, M.D. contact
Weishi Li, M.D. principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Adjacent Segment Disease and Adjacent Segment Degeneration, 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 3 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 21 Jul 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 Weishi Li, M.D. ((+86010)62017691-7011, puh3liweishi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) scores of low back pain and leg pain (time frame: 2 years after revision surgery). 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 21 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.