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NCT06617338 | NOT YET RECRUITING | Osteoarthritis (OA) of the Knee

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

University of Louisville

Information provided by (Responsible Party):

arthur malkani

Brief Summary:

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

Condition or disease

Osteoarthritis (OA) of the Knee

Intervention/treatment

CT scan unilateral knee

CT scan bilateral knee

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty
Actual Study Start Date : 2024-11-07
Estimated Primary Completion Date : 2026-04-30
Estimated Study Completion Date : 2026-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 89 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty

Location Details

NCT06617338

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Kentucky

UofL Health

Louisville, Kentucky, United States, 40202