NCT06614296

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 24, 2024

Last Update Submit

September 27, 2024

Conditions

Keywords

Spine Degeneration

Outcome Measures

Primary Outcomes (1)

  • Unscheduled readmission

    Unscheduled readmission refers to a patient who was unplanned or unexpected return to the hospital after CLIF discharged from a previous hospitalization.

    1 year

Study Arms (2)

Unscheduled readimission

Unscheduled readimission after CLIF

Procedure: Crenel lateral interbody fusion plus second stage surgery

Scheduled readimission

Scheduled readimission after CLIF

Procedure: Crenel Lateral Interbody Fusion

Interventions

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.

Also known as: Lateral Lumbar Interbody Fusion
Scheduled readimission

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.

Unscheduled readimission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (\>18 years old) with spinal degeneration undergoing CLIF surgery, including both unscheduled and scheduled readmissions.

You may qualify if:

  • Patients with spinal degeneration undergoing CLIF surgery

You may not qualify if:

  • Under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

April 3, 2024

Primary Completion

July 25, 2024

Study Completion

August 2, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations