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Clinical Trials/NCT05295602
NCT05295602
Completed
N/A

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

Valdoltra Orthopedic Hospital1 site in 1 country200 target enrollmentDecember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Valdoltra Orthopedic Hospital
Enrollment
200
Locations
1
Primary Endpoint
Correlation between coronal alignment and tibial tuberosity rotation
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
January 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Valdoltra Orthopedic Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients requiring knee arthroplasty

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Correlation between femoral anteversion and tibial tuberosity position(Before surgery)
  • Difference in tibial tuberosity position according to the osteoarthritis grade(Before surgery)

Study Sites (1)

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