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

NCT ID: NCT04784923

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-07-31

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.

Conditions

Orthopedics

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Instrumentation patients

Instrumentation patients

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen-Kun Liaw

Role: STUDY_CHAIR

Taipei Medical University

Central Contacts

Chen-Kun Liaw

Role: CONTACT

chenkunliaw@tmu.edu.tw

+886963969162

Other Identifiers

N202007008

Identifier Type: -

Identifier Source: org_study_id