Femoral External Rotation Measured on CT and MRI

April 14, 2022 updated by: xiangshuai, The Affiliated Hospital of Qingdao University

A Prospective Cohort Study to Compare the Accuracy of Femoral External Rotation Measured on CT and MRI

This study aims to compare the femoral external rotation measured on CT and MRI to that measured intraoperatively to clarify the influence of residual cartilage on posterior condyle on the preoperative planning of total knee arthroplasty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
        • Principal Investigator:
          • Shuai Xiang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients underwent TKA due to knee arthroplasty (Kellgren-Lawrence Grade III or IV)

Description

Inclusion Criteria:

  1. 50-85 years old
  2. patients with osteoarthritis (Kellgren-Lawrence Grade III or IV) underwent total knee arthroplasty.

Exclusion Criteria:

  1. patients cannot endure TKA due to severe heart failure, arrhythmia, myocardial infarction, infection or other reason.
  2. patients who cannot undergo MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Other: CT and MRI
CT and MRI were conducted to measure the femoral external rotation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femoral external rotation on CT
Time Frame: Preoperative
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on CT
Preoperative
Femoral external rotation on MRI
Time Frame: Preoperative
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on MRI
Preoperative
Intraoperative femoral external rotation
Time Frame: Intraoperative
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) measured intraoperatively
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Qingdao University

Investigators

  • Principal Investigator: Shuai Xiang, The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QYFYKYLL 915211920

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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