The Influence of Coronally Knee Alignment on the Tibial Tuberosity Rotation

NCT ID: NCT05295602

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CT scan

Intervention Type RADIATION

CT of lower leg

Interventions

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CT scan

CT of lower leg

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* patients requiring knee arthroplasty

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valdoltra Orthopedic Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrej Strahovnik

Role: PRINCIPAL_INVESTIGATOR

Valdoltra Orthopaedic Hospital

Locations

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Orthopaedic Hospital Valdoltra

Ankaran, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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Valdoltra - TT rotation

Identifier Type: -

Identifier Source: org_study_id

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