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Clinical Trials/NCT04784923
NCT04784923
Unknown
Not Applicable

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

Taipei Medical University0 sites20 target enrollmentMarch 2021
ConditionsOrthopedics

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthopedics
Sponsor
Taipei Medical University
Enrollment
20
Primary Endpoint
Verify the position of pedicle screw on X-ray compared to that on CT's
Last Updated
5 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 2021
End Date
July 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Verify the position of pedicle screw on X-ray compared to that on CT's

Time Frame: 30 days

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.

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