200 Participants Needed

Knee Implant Alignment for Osteoarthritis

LS
SK
Overseen BySeth Knight, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Louisville
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for individuals with osteoarthritis in need of total knee arthroplasty (TKA). Candidates should have one knee affected by arthritis and the other not, as alignment from the non-arthritic side will be used for comparison. Participants must follow up regularly post-surgery.

Inclusion Criteria

I am between 21 and 89 years old.
I am scheduled for knee replacement surgery due to arthritis.
Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
See 1 more

Exclusion Criteria

I have a history of stroke, heart bypass surgery, or atrial fibrillation.
I am younger than 21 years old.
Current smoker
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants receive either a unilateral or bilateral knee CT preoperatively and are randomized into one of two study arms

1-2 weeks

Treatment

Participants undergo primary robotic-assisted total knee arthroplasty (RA-TKA) based on the assigned study arm

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 2 weeks, 6 weeks, and 1 year postoperatively

1 year
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Native Alignment
Trial Overview The study tests if using the alignment of a patient's non-arthritic knee to guide TKA on their arthritic knee leads to better outcomes than traditional methods. It involves random assignment to either use this new technique or stick with standard practices, followed by regular evaluations.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Participant receives bilateral knee CT preoperativelyExperimental Treatment1 Intervention
Group II: Participant receives unilateral CT of the operative knee preoperativelyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials
353
Recruited
76,400+
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