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Procedure

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Forgotten Joint Score
Incidence of revision TKA
KOOS JR
+4 more
Secondary study objectives
Active ROM

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
345 Previous Clinical Trials
77,389 Total Patients Enrolled
1 Trials studying Osteoarthritis
158 Patients Enrolled for Osteoarthritis
~133 spots leftby Apr 2026
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