Detecting Malposition of Trans-pedicle Screw From AP and LAT Plain Radiographs
1 other identifier
observational
20
0 countries
N/A
Brief Summary
Our study focuses on reducing the use of CT (Computer Tomography) for pedicle screw instrumentation, replacing CT with X-ray. We are writing a program to measure the position on X-ray seeing whether the position meets that on CT after operation. In the future,our method can be used in fluoroscopy, helping us detecting screw malposition efficiently during the surgeries, and hoping reduce complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedMarch 5, 2021
June 1, 2020
4 months
February 22, 2021
March 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Verify the position of pedicle screw on X-ray compared to that on CT's
Investigators will verify CT method's reproducibility by interobserver and intra-observer reliability test. With the same databank, investigators will use the plain radiograph method again, and test if the two methods' results are the same by Chi-square test.
30 days
Study Arms (1)
Instrumentation patients
Instrumentation patients
Eligibility Criteria
Patients from Shuang Ho Hospital
You may qualify if:
- s/p pedicle screw insertion surgery
- good quality postoperative plain radiograph
- good quality postoperative CT
You may not qualify if:
- poor quality postoperative plain radiograph
- poor quality postoperative CT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY CHAIR
Chen-Kun Liaw
Taipei Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
March 5, 2021
Study Start
March 1, 2021
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
March 5, 2021
Record last verified: 2020-06