Detecting Malposition of Trans-pedicle Screw From AP and LAT Plain Radiographs

Orthopedics Clinical Trial

Official title:

Detecting Malposition of Trans-pedicle Screw From AP and LAT Plain Radiographs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04784923
• Other study ID #: N202007008
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: July 2021

Study information

• Verified date: June 2020
• Source: Taipei Medical University
• Contact: Chen-Kun Liaw
• Phone: +886963969162
• Email: chenkunliaw[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Most of the spine surgeries are decompression, fusion, with instrumentation.Instrumentation 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 dose.We 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 CT(or MRI) and postoperative plain radiographs and CT. We will firstly verify CT method's 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 future,our method can be used in fluoroscopy, helping us detecting screw malposition efficiently during the surgeries, and hoping reduce complications.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• s/p pedicle screw insertion surgery

• good quality postoperative plain radiograph

• good quality postoperative CT

Exclusion Criteria:

• poor quality postoperative plain radiograph

• poor quality postoperative CT

Related Conditions & MeSH terms

• Orthopedics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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