Knee Implant Alignment for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Louisville

No Placebo Group

Trial Summary

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

Research Team

Eligibility Criteria

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 can read and speak English.

I am scheduled for knee replacement surgery due to arthritis.

See 2 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 3 more

Trial Timeline

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)

Treatment Details

Interventions

Native Alignment (Procedure)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Participant receives bilateral knee CT preoperativelyExperimental Treatment1 Intervention

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

Group II: Participant receives unilateral CT of the operative knee preoperativelyActive Control1 Intervention

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