The Influence of Coronally Knee Alignment on the Tibial Tuberosity Rotation

April 10, 2022 updated by: Valdoltra Orthopedic Hospital

The Relationship of Radiological Lower Limb Alignment and Grade of the Knee Osteoarthritis With the Position of the Tibial Tuberosity

The primary aim of this study is to find a possible correlation between tibial tuberosity rotation and coronal leg alignment. If correlation exists, a more individual tibial component rotation might be proposed during a total knee arthroplasty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A malalignment of the tibial component is a possible source of pain after a total knee arthroplasty. Currently, an internal rotation of the tibial component of 18 degrees is considered as a golden standard. The value was obtained as an average rotation in the osteoarthritic knees scheduled for a total knee arthroplasty.

It is known that the femur internally rotates with the increasing valgus alignment. It would seem logical that also tibial rotation correlates with the coronal limb alignment (varus-valgus). The plan is to measure the native tibial rotation (angle between the transposed epicondylar line and the posterior cruciate-tibial tuberosity line). In order to get the necessary accuracy a CT of lower legs will be obtained in patients waiting for the knee replacement. If there is a correlation between the angles the adjustment of the tibial component rotation more to the patient's anatomy could be proposed.

A secondary outcome measure is the possible correlation between the proximal femoral anteversion and the tibial tuberosity rotation. The hypothesis is that the extensor mechanism follows the proximal femoral orientation. With increasing femoral anteversion (increases with valgus angle) the femoral part of the knee rotates internally. In order to keep the extensor mechanism in the direction of walking, a more lateralized position of the tibial tuberosity is expected.

Study Type

Observational

Enrollment (Anticipated)

200

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients waiting for the knee arthroplasty will be asked to participate. Patients with pre-existing deformities will not be enrolled. Additionally, women in reproductive age will also not be enrolled to avoid unnecessary radiation risks.

Description

Inclusion Criteria:

  • patients requiring knee arthroplasty

Exclusion Criteria:

  • women in reproductive age, patients with leg deformities and previous hip/knee surgery

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group
A CT scan of both legs will be made in patient scheduled for a primary knee arthroplasty. No other additional intervention will be made apart from those already routinely used for the operation.
Radiation: CT scan
CT of lower leg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between coronal alignment and tibial tuberosity rotation
Time Frame: Before surgery
A hip-knee-ankle angle and a tibial rotation angle (angle between the transposed epicondylar line) will be calculated from the CT scan of the leg. A correlation between both angles will be analysed using the Spearmans's coefficient.
Before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between femoral anteversion and tibial tuberosity position
Time Frame: Before surgery
A femoral anteversion angle (angle between femoral hip neck and posterior condylar knee line) and tibial tuberosity position (angle between posterior condylar line and posterior cruciate - tibial tuberosity line) will be measured and examined for correlation using a Spearman's coefficient.
Before surgery
Difference in tibial tuberosity position according to the osteoarthritis grade
Time Frame: Before surgery
Tibial tuberosity position will be compared according to the Kellgren-Lawrence grade with the ANOVA
Before surgery

Collaborators and Investigators

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

Sponsor

Valdoltra Orthopedic Hospital

Investigators

  • Principal Investigator: Andrej Strahovnik, Valdoltra Orthopaedic Hospital

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)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Valdoltra - TT rotation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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