Clinical Correlation of TKA Alignment and Native Knee Anatomy

NCT05435092 | Active Not Recruiting

• 1 other identifier: 2022-00084; mu22Mueller
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty (TKA)

Keywords

osteoarthritis; knee protheses; knee replacement; knee alignment; knee pain; 3D-reconstruction Computer Tomography

Outcome Measures

Primary Outcomes (1)

• Deviation of TKA alignment from preoperative native knee alignment in the coronal plane

  Primary radiographic endpoints to assess alignment deviations in the coronal plane: 1. Whole limb mechanical axis (hip-knee-ankle (HKA) angle, preoperative) 2. Native femoral varus/valgus alignment (preoperative) 3. Native tibial varus/valgus alignment (preoperative) 4. Femoral component varus/valgus alignment 5. Tibial component varus/valgus alignment

  3 months

Secondary Outcomes (3)

• Evaluation of the Sagittal alignment

  3 months

• Evaluation of the Axial alignment

  3 months

• Assessment of Clinical, functional and biomechanical parameters

  2 years

Other Outcomes (1)

• Deviation of preoperative native knee alignment from neutral alignment in the coronal plane

  3 months

Study Arms (1)

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

Interventions

3D-reconstruction CT RADIATION

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).

Patients scheduled for primary TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4052, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andreas M. Müller, Prof.Dr.med.

  University Hospital of Basel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 28, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

CH (1)