Degenerative ScoliosisNCT04960423
Clinical Study of Imaging and Endoplant-related Mechanical Complications After Long Segment Fixation and Fusion of Degenerative Lumbar Scoliosis (DLS)
An observational study of Degenerative Scoliosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
There is a high probability of mechanical complications in patients with degenerative lumbar scoliosis after long segment fixation and fusion, and there are few studies on distal borderline kyphosis deformity/failure. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Degenerative Scoliosis
- What is being tested?
- Long Segment Fixation and Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2025
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: From April 2009 to May 2019, patients with degenerative lumbar scoliosis (DLS) underwent posterior selective decompression and long segment fixation and fusion surgery in the Department of Orthopaedic Lumbar Surgery of our hospital
Who may be able to join
- Age ≥45 years old;
- The number of fixed vertebral bodies ≥5, and the upper instrumented vertebra (UIV) is located in the thoracolumbar segment;
- Third generation total pedicle screw internal fixation system;
- Follow-up time ≥24 months;
- Complete clinical and imaging data.
Who cannot join
- Idiopathic scoliosis, neuromuscular scoliosis, non-structural scoliosis, spinal tumors, spinal tuberculosis, ankylosing spondylitis, humman's disease, history of spinal surgery, history of spinal trauma, and history of hip surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University of Third Hospital
Beijing, Beijing Municipality, 100191
Yan Zeng, M.D., (+86010)62017691 ext. 7311, zy7311@sohu.com
About this study
There is a high probability of mechanical complications in patients with degenerative lumbar scoliosis after long segment fixation and fusion, and there are few studies on distal borderline kyphosis deformity/failure. This study was designed to retrospectively analyze the patients with degenerative lumbar scoliosis (DLS) who underwent posterior selective decompression and long segment fixation and fusion surgery in the lumbar spine department of our hospital from April 2009 to May 2016. Patients' basic data, surgical data and preoperative, immediate postoperative and follow-up imaging data were collected to study the incidence of distal mechanical complications, risk factors and their relationship with clinical symptom scores in DLS patients undergoing posterior selective decompression and long segment fixation and fusion. It has guiding significance for clinical operation decision making.
- Conditions
- Degenerative Scoliosis
- Being tested
- Long Segment Fixation and Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Segment Fixation and FusionProcedure or surgery
Long Segment Fixation and Fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging and Endoplant-related Mechanical Complications
PJK, DJK
Measured: 2019.1.1-2025.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ScoliosisStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960423
- Sponsor's protocol ID
- LM2018106
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 13 Jul 2021
- 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 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Imaging and Endoplant-related Mechanical Complications After Long Segment Fixation and Fusion of Degenerative Lumbar Scoliosis (DLS)
- ClinicalTrials.gov ID
- NCT04960423
- Acronym / sponsor ID
- LM2018106
- Conditions
- Degenerative Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 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.
There is a high probability of mechanical complications in patients with degenerative lumbar scoliosis after long segment fixation and fusion, and there are few studies on distal borderline kyphosis deformity/failure. This study was designed to retrospectively analyze the patients with degenerative lumbar scoliosis (DLS) who underwent posterior selective decompression and long segment fixation and fusion surgery in the lumbar spine department of our hospital from April 2009 to May 2016. Patients' basic data, surgical data and preoperative, immediate postoperative and follow-up imaging data were collected to study the incidence of distal mechanical complications, risk factors and their relationship with clinical symptom scores in DLS patients undergoing posterior selective decompression and long segment fixation and fusion. It has guiding significance for clinical operation decision making.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- From April 2009 to May 2019, patients with degenerative lumbar scoliosis (DLS) underwent posterior selective decompression and long segment fixation and fusion surgery in the Department of Orthopaedic Lumbar Surgery of our hospital
Key inclusion criteria (5 listed)
- Age ≥45 years old;
- The number of fixed vertebral bodies ≥5, and the upper instrumented vertebra (UIV) is located in the thoracolumbar segment;
- Third generation total pedicle screw internal fixation system;
- Follow-up time ≥24 months;
- Complete clinical and imaging data.
Key exclusion criteria (1 listed)
- Idiopathic scoliosis, neuromuscular scoliosis, non-structural scoliosis, spinal tumors, spinal tuberculosis, ankylosing spondylitis, humman's disease, history of spinal surgery, history of spinal trauma, and history of hip surgery
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 |
|---|---|---|
| Long Segment Fixation and FusionLong Segment Fixation and Fusion | Procedure or surgery | – |
Primary outcome
Imaging and Endoplant-related Mechanical Complications
Time frame: 2019.1.1-2025.12.31
PJK, DJK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
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 Scoliosis, run by Peking University Third 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 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 13 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging and Endoplant-related Mechanical Complications (time frame: 2019.1.1-2025.12.31). 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 13 Jul 2021.