Clinical trial NCT05295602: The Influence of Coronally Knee Alignment on the Tibial Tuberosity Rotation
Official title: The Relationship of Radiological Lower Limb Alignment and Grade of the Knee Osteoarthritis With the Position of the Tibial Tuberosity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: knee alignment
knee arthroplasty
tibial component rotation
Lead sponsor: Valdoltra Orthopedic Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* patients requiring knee arthroplasty

Exclusion Criteria:

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

Primary outcomes:
measure: Correlation between coronal alignment and tibial tuberosity rotation
timeFrame: Before surgery
Secondary outcomes:
measure: Correlation between femoral anteversion and tibial tuberosity position
timeFrame: Before surgery
measure: Difference in tibial tuberosity position according to the osteoarthritis grade
timeFrame: Before surgery
Other outcomes:
Locations:
city: Ankaran
country: Slovenia
facility: Orthopaedic Hospital Valdoltra
Study officials:
affiliation: Valdoltra Orthopaedic Hospital
name: Andrej Strahovnik
role: PRINCIPAL_INVESTIGATOR
References: