Image

Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty

Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty

Recruiting
21-89 years
All
Phase N/A

Powered by AI

Overview

The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.

The main questions it aims to answer are:

  • Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?
  • What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.

Participants will:

  • Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively
  • Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.
  • Complete postop questionnaires (PROMs) at the prescribed follow-up intervals

Eligibility

Inclusion Criteria:

  1. Patient age is 21-89 at time of surgery
  2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
  3. Patient's contralateral knee is non-arthritic
  4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
  5. Patient is able to read and speak English.

Exclusion Criteria:

  1. Patient is under the age of 21
  2. Patient's primary diagnosis is not osteoarthritis
  3. Patient is unable to read and speak English
  4. History of previous DVT/PE
  5. History of stroke, CABG, or A fib
  6. Current smoker

Study details
    Osteoarthritis (OA) of the Knee

NCT06617338

University of Louisville

10 September 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.