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

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.

Study Overview

• Status: Unknown
• Conditions: Orthopedics

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from Shuang Ho Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Instrumentation patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: N202007008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No