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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 89 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06617338
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Louisville
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis (OA) of the Knee

Arms & Interventions

Arms

Experimental: Participant receives bilateral knee CT preoperatively

The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA

Active Comparator: Participant receives unilateral CT of the operative knee preoperatively

The P.I. will use the traditional method to obtain target alignment for RA-TKA.

Interventions

Diagnostic Test: - CT scan unilateral knee

Intervention given to the Active Comparator arm

Diagnostic Test: - CT scan bilateral knee

Intervention given to the Experimental Arm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UofL Health, Louisville, Kentucky

Status

Recruiting

Address

UofL Health

Louisville, Kentucky, 40202

Site Contact

Langan S Smith, BS

[email protected]

5025878222 #65585

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