Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784923
Status:
UNKNOWN
Last Update Posted:
2021-03-05
First Post:
2021-02-22
Brief Title:
Detecting Malposition of Trans-pedicle Screw From AP and LAT Plain Radiographs
Sponsor:
Taipei Medical University
Organization:
Taipei Medical University
Study Overview
Official Title:
Detecting Malposition of Trans-pedicle Screw From AP and LAT Plain Radiographs
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 futureour method can be used in fluoroscopy helping us detecting screw malposition efficiently during the surgeries and hoping reduce complications
Detailed Description:
Most of the spine surgeries are decompression fusion with instrumentationInstrumentation needs screws Pedicle screws are often used If the pedicle screws are mal-located that is breaking the pedicle wall the consequence may be injury of the spinal cord or nerve root Some lucky patients may have no symptom however broken pedicle will reduce the fixation strength which may reduce fusion rate
Detecting malposition screws currently we use CT computer tomography method The surgeon carefully read the CT slice by slice looking for clues of screws malposition However CT is costly both price and radiation doseWe invented a plain radiograph method which has been pilot tested in one patient with good correction rate The purpose of this study is to solve the following two clinical problems
1 What are the inter-observer and intra-observer reliabilities of CT method
2 The radiation dose for CT method is too high Does our plain radiograph method has the same correction rate Materials and methods We planned to collect about 100 patients received spinal fusion and instrumentation who has preoperative CTor MRI and postoperative plain radiographs and CT We will firstly verify CT methods reproducibility by interobserver and intra-observer reliability test With the same databank we will use our plain radiograph method again and test if the two methods results are the same by Chi-square test
Conclusion
We hope our study can reduce some unnecessary CT examination In the futureour method can be used in fluoroscopy helping us detecting screw malposition efficiently during the surgeries and hoping reduce complications
Detecting malposition screws currently we use CT computer tomography method The surgeon carefully read the CT slice by slice looking for clues of screws malposition However CT is costly both price and radiation doseWe invented a plain radiograph method which has been pilot tested in one patient with good correction rate The purpose of this study is to solve the following two clinical problems
1 What are the inter-observer and intra-observer reliabilities of CT method
2 The radiation dose for CT method is too high Does our plain radiograph method has the same correction rate Materials and methods We planned to collect about 100 patients received spinal fusion and instrumentation who has preoperative CTor MRI and postoperative plain radiographs and CT We will firstly verify CT methods reproducibility by interobserver and intra-observer reliability test With the same databank we will use our plain radiograph method again and test if the two methods results are the same by Chi-square test
Conclusion
We hope our study can reduce some unnecessary CT examination In the futureour method can be used in fluoroscopy helping us detecting screw malposition efficiently during the surgeries and hoping reduce complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None