Clinical trial NCT05435092: Clinical Correlation of TKA Alignment and Native Knee Anatomy
Official title: Influence of Native Knee Anatomy on Alignment and Outcome After Total Knee Arthroplasty CAT - Clinical Correlation of TKA Alignment and Native Knee Alignment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Knee Arthroplasty (TKA)
Keywords: osteoarthritis
knee protheses
knee replacement
knee alignment
knee pain
3D-reconstruction Computer Tomography
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis who are scheduled for a primary total knee arthroplasty

Brief summary: Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis. In the last decades neutral mechanical knee alignment in the coronal plane has been considered the gold standard. However, the optimal TKA alignment is still debated. Today, component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images are considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.

Detailed description: Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis resulting in pain and functional improvement. Despite the development of novel prosthetic design and improved outcome, about 20% of patients report persisting pain interfering with their daily activities.Total knee prostheses are aligned in the coronal, sagittal and axial planes during implantation. In the last decades, neutral mechanical knee alignment in the coronal plane has been considered the gold standard. The aim of mechanical alignment in TKA is to achieve a femorotibial joint line that is perpendicular to the mechanical axis of the long leg axis hence correcting any varus-valgus deformity via prosthesis placement with the goal of equally distributing the load between the medial and lateral prosthesis component. However, the optimal TKA alignment is still debated. Traditionally, knee alignment and total knee arthroplasty component position have been assessed using radiographs. However, this method has a low accuracy and reliability because of variation in limb rotation, knee extension deficit, patient positioning, or magnification factors. Component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images have replaced former methods and are now considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Diagnosed osteoarthritis of the knee
* Planned primary total knee arthroplasty (cruciate retaining (CR) or posterior stabilizing (PS) designs)

Exclusion Criteria:

* Inability to provide informed consent
* Inability to communicate in German, French, Italian or English
* Any previous ipsilateral bony knee procedure prior to TKA
* Planned partial knee arthroplasty, semi- or full-constrained knee prosthesis
* Patients unlikely to attend clinical follow-up (e.g., when living abroad)
* Pregnancy
* Female participants of childbearing potential, not using a medically reliable method of contraception, who do not wish to undergo a pregnancy test prior to exposure to i ionizing radiation

Primary outcomes:
measure: Deviation of TKA alignment from preoperative native knee alignment in the coronal plane
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the Sagittal alignment
timeFrame: 3 months
measure: Evaluation of the Axial alignment
timeFrame: 3 months
measure: Assessment of Clinical, functional and biomechanical parameters
timeFrame: 2 years
Other outcomes:
measure: Deviation of preoperative native knee alignment from neutral alignment in the coronal plane
timeFrame: 3 months
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: University Hospital of Basel
name: Andreas M. Müller, Prof.Dr.med.
role: STUDY_DIRECTOR
References: