RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-12-12
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06617338

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient age is 21-89 at time of surgery
  2. 2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
  3. 3. Patient's contralateral knee is non-arthritic
  4. 4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
  5. 5. Patient is able to read and speak English.
  1. 1. Patient is under the age of 21
  2. 2. Patient's primary diagnosis is not osteoarthritis
  3. 3. Patient is unable to read and speak English
  4. 4. History of previous DVT/PE
  5. 5. History of stroke, CABG, or A fib
  6. 6. Current smoker

Contacts and Locations

Study Contact

Langan S Smith, BS
CONTACT
5025878222
langan.smith@uoflhealth.org
Seth Knight, BS
CONTACT
5025878222
seth.knight@louisville.edu

Study Locations (Sites)

UofL Health
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2024-12-12
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • osteoarthritis
  • knee
  • total knee arthroplasty
  • target alignment

Additional Relevant MeSH Terms

  • Osteoarthritis (OA) of the Knee