Pre-operative Radiological Measurement to Assess Femur Rotational Alignment

June 27, 2016 updated by: Xi'an Honghui Hospital

Pre-operative Radiological Measurement of Proximal Tibia Angle to Assess Femur Rotational Alignment in Total Knee Arthroplasty

Purpose: This study outlines the benefits of the proximal tibia angle (PTA) in evaluation of the pre-operative individual condylar twist angle (CTA) in total knee arthroplasty.

Methods: Condylar twist angle and proximal tibia angle were obtained from 33 female healthy participants using computed tomography (CT). The CTA, angle between clinical transepicondylar axis and posterior condylar line were measured. The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line. The correlation between the CTA and the PTA was analyzed statistically with the linear regression.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

33

Contacts and Locations

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

Study Locations

  • China
      • Xi'an, China
        • Recruiting
        • Hong-hui Hospital
        • Contact:
          • Qiang He, MD
          • Phone Number: 02983860818
    • Shanxi
      • Xi'an, Shanxi, China, 710054

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Chinese female patients with primary varus knee OA, scheduled for primary TKAs

Description

Inclusion Criteria:

  • Osteoarthritis Varus knee deformity

Exclusion Criteria:

  • Rheumatoid arthritis valgus knee OA previous knee surgeries posttraumatic arthritis

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
CT
Measured with computed tomography
plain Radiography
Measured with plain Radiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proximal tibia angle (PTA)
Time Frame: Four months
The PTA is the angle formed between the mechanical axis of the tibia and tibia plateau line.
Four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Condylar twist angle (CTA)
Time Frame: Four months
The CTA is the angle between clinical transepicondylar axis and posterior condylar line
Four months

Collaborators and Investigators

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

Sponsor

Xi'an Honghui Hospital

Investigators

  • Study Director: Jianbing Ma, MD, Honghui hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • XianHongHuiH

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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