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Completed

NCT Number: NCT05295602

The Influence of Coronally Knee Alignment on the Tibial Tuberosity Rotation

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Hospital Valdoltra

Ankaran, 6820, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients requiring knee arthroplasty

Exclusion criteria

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

Treatment and study plan

CT Scan

Radiation

CT of lower leg

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Valdoltra Orthopedic Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 25, 2022
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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