Knee Implant Alignment for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient age is 21-89 at time of surgery

Patient is able to read and speak English

Must not have

History of stroke, CABG, or A fib

Patient is under the age of 21

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if aligning the knee implant based on the non-arthritic side will result in better outcomes compared to the traditional method of using the arthritic side. The study will

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, typical risks associated with CT scans include exposure to radiation. Knee surgery can lead to pain, swelling, infection risk at the incision site, blood clots, and issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 89 years old.

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I can read and speak English.

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I am scheduled for knee replacement surgery due to arthritis.

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My other knee does not have arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of stroke, heart bypass surgery, or atrial fibrillation.

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I am younger than 21 years old.

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I cannot read or speak English.

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I have had a blood clot in my leg or lung before.

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My primary diagnosis is not osteoarthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively for reporting.