Spine DegenerationNCT06614296
Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion
An observational study of Spine Degeneration, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to learn about the readmission related to Crenel Lateral Interbody Fusion (CLIF). The main question it aims to answer is: What are the risk factors for readmission after CLIF surgery? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Degeneration
- What is being tested?
- Crenel Lateral Interbody Fusion and Crenel lateral interbody fusion plus second stage surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2024to 2 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (\>18 years old) with spinal degeneration undergoing CLIF surgery, including both unscheduled and scheduled readmissions.
Who may be able to join
- Patients with spinal degeneration undergoing CLIF surgery
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Factors and Experiences Associated with Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion
The goal of this observational study is to learn about the readmission related to Crenel Lateral Interbody Fusion (CLIF). The main question it aims to answer is:
What are the risk factors for readmission after CLIF surgery?
- Conditions
- Spine Degeneration
- Being tested
- Crenel Lateral Interbody Fusion, Crenel lateral interbody fusion plus second stage surgery
- Keywords
- Spine Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crenel Lateral Interbody FusionProcedure or surgery
Also called Lateral Lumbar Interbody Fusion
The Crenel Lateral Interbody Fusion (CLIF) is a surgical technique developed by the Department of Spine Surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Building on the traditional Lateral Lumbar Interbody Fusion technique, this series of technical improvements overcomes the shortcomings of previous surgical methods, enhancing the safety, operability, and effectiveness of the surgery while reducing complications.
Crenel lateral interbody fusion plus second stage surgeryProcedure or surgery
The patient was first admitted to undergo CLIF surgery and was discharged after the operation. The patient will return to the hospital for a second surgery at the scheduled time.
| Study group | Role | What they receive |
|---|---|---|
| Unscheduled readimission | Unscheduled readimission after CLIF Receives: Procedure: Crenel lateral interbody fusion plus second stage surgery | |
| Scheduled readimission | Scheduled readimission after CLIF Receives: Procedure: Crenel Lateral Interbody Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unscheduled readmission
Unscheduled readmission refers to a patient who was unplanned or unexpected return to the hospital after CLIF discharged from a previous hospitalization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start3 Apr 2024
- Primary completion25 Jul 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DegenerationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614296
- Sponsor's protocol ID
- 2024-0165
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors and Experiences Associated with Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion
- ClinicalTrials.gov ID
- NCT06614296
- Acronym / sponsor ID
- 2024-0165
- Conditions
- Spine Degeneration
- Keywords
- Spine Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 26 Sep 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 goal of this observational study is to learn about the readmission related to Crenel Lateral Interbody Fusion (CLIF). The main question it aims to answer is:
What are the risk factors for readmission after CLIF surgery?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unscheduled readimission | – | Procedure: Crenel lateral interbody fusion plus second stage surgeryUnscheduled readimission after CLIF |
| Scheduled readimission | – | Procedure: Crenel Lateral Interbody FusionScheduled readimission after CLIF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (\>18 years old) with spinal degeneration undergoing CLIF surgery, including both unscheduled and scheduled readmissions.
Key inclusion criteria (1 listed)
- Patients with spinal degeneration undergoing CLIF surgery
Key exclusion criteria (1 listed)
- Under the age of 18
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 |
|---|---|---|
| Crenel Lateral Interbody FusionAlso: Lateral Lumbar Interbody FusionThe Crenel Lateral Interbody Fusion (CLIF) is a surgical technique developed by the Department of Spine Surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Building on the traditional Lateral Lumbar Interbody Fusion technique, this series of technical improvements overcomes the shortcomings of previous surgical methods, enhancing the safety, operability, and effectiveness of the surgery while reducing complications. | Procedure or surgery | Scheduled readimission |
| Crenel lateral interbody fusion plus second stage surgeryThe patient was first admitted to undergo CLIF surgery and was discharged after the operation. The patient will return to the hospital for a second surgery at the scheduled time. | Procedure or surgery | Unscheduled readimission |
Primary outcome
Unscheduled readmission
Time frame: 1 year
Unscheduled readmission refers to a patient who was unplanned or unexpected return to the hospital after CLIF discharged from a previous hospitalization.
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 1 Oct 2024.
- Individual participant dataSharing planned: Yes
Related trials for Spine Degeneration
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
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 Spine Degeneration, run by Second Affiliated Hospital, 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 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: finished, as of the sponsor's last update on 1 Oct 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?
Unscheduled readmission (time frame: 1 year). 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 1 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.