The Influence of Coronally Knee Alignment on the Tibial Tuberosity Rotation

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295602
• Other study ID #: Valdoltra - TT rotation
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Valdoltra Orthopedic Hospital
• Contact: Andrej Strahovnik
• Phone: +38641600657
• Email: andrej_strahovnik[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients requiring knee arthroplasty

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Radiation:
• CT scan
CT of lower leg

Locations

Country	Name	City	State
Slovenia	Orthopaedic Hospital Valdoltra	Ankaran

Sponsors (1)

Lead Sponsor	Collaborator
Valdoltra Orthopedic Hospital

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between coronal alignment and tibial tuberosity rotation	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	Correlation between femoral anteversion and tibial tuberosity position	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
Secondary	Difference in tibial tuberosity position according to the osteoarthritis grade	Tibial tuberosity position will be compared according to the Kellgren-Lawrence grade with the ANOVA	Before surgery