Clinical Correlation of TKA Alignment and Native Knee Anatomy (CAT)

Influence of Native Knee Anatomy on Alignment and Outcome After Total Knee Arthroplasty CAT - Clinical Correlation of TKA Alignment and Native Knee Alignment

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.

Study Overview

• Status: Recruiting
• Conditions: Total Knee Arthroplasty (TKA)
• Intervention / Treatment: Radiation: 3D-reconstruction CT

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Yves Acklin, PD Dr. med.; Phone Number: +41 61 315 27 71; Email: yves.acklin@usb.ch
• Study Contact Backup: Name: Matthias Wittauer, Dr. med.; Phone Number: +41 61 315 27 44; Email: matthias.wittauer@usb.ch

Study Locations

• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4052
      • Recruiting
      • University Hospital Basel
      • Contact: Yves Acklin, PD.Dr.med.; Phone Number: +41 61 315 27 71; Email: yves.acklin@usb.ch
      • Contact: Matthias Wittauer, Dr.med; Phone Number: +41 61 315 27 44; Email: matthias.wittauer@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with knee osteoarthritis who are scheduled for a primary total knee arthroplasty

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients scheduled for primary TKA; Adult Patients diagnosed with osteoarthritis of the knee and who are scheduled for a primary total knee arthroplasty	Radiation: 3D-reconstruction CT; Three dimensional CT (3D CT):Method of surface rendition of anatomy by means of a special computer software to capture 3D bone models used to improve the outcomes of Total Knee Arthroplasty (TKA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deviation of TKA alignment from preoperative native knee alignment in the coronal plane	Primary radiographic endpoints to assess alignment deviations in the coronal plane: Whole limb mechanical axis (hip-knee-ankle (HKA) angle, preoperative); Native femoral varus/valgus alignment (preoperative); Native tibial varus/valgus alignment (preoperative); Femoral component varus/valgus alignment; Tibial component varus/valgus alignment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Sagittal alignment	Evaluation of the; Flexion/extension alignment of the femur (preoperative); Native tibial posterior slope (preoperative); Flexion/extension alignment of the femoral component; Tibial component posterior slope	3 months
Evaluation of the Axial alignment	Evaluation of the; Native femoral rotation (preoperative); Native tibial rotation (preoperative); Rotation of the femoral component; Rotation of the tibial component; Component mismatch rotation	3 months
Assessment of Clinical, functional and biomechanical parameters	Functional scores: Oxford Knee Score (OKS); Knee Osteoarthritis Outcome Score (KOOS); KSS (Knee Society Score); NPRS (numeric pain rating scale); EQ-5D-5L Biomechanical parameters: Spatiotemporal parameters: walking speed, cadence, stride length, stride duration; Sagittal plane kinematic parameters: difference in dynamic knee flexion range of motion stance, dynamic knee flexion range of motion gait cycle and dynamic hip flexion range of motion stance between affected and unaffected leg; Ambulatory joint mechanics parameters: differences in 3-dimensional joint moments and medial and lateral compartment contact forces, tibia rotation, tibia translation and muscle activation patterns; Muscle strength: Differences in isokinetic muscle strength in knee flexion and knee extension Local adverse events: persistent or worsening pain; infection; any local event	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deviation of preoperative native knee alignment from neutral alignment in the coronal plane	Primary radiographic endpoints to assess alignment deviations in the coronal plane: Whole limb mechanical axis (hip-knee-ankle (HKA) angle, preoperative); Native femoral varus/valgus alignment (preoperative); Native tibial varus/valgus alignment (preoperative); Femoral component varus/valgus alignment; Tibial component varus/valgus alignment	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Director: Andreas M. Müller, Prof.Dr.med., University Hospital of Basel

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; knee pain; knee replacement; knee alignment; knee protheses; 3D-reconstruction Computer Tomography
• Other Study ID Numbers: 2022-00084; mu22Mueller

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No