Knee Implant Alignment for Osteoarthritis

Overseen By Seth Knight, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: DVT/PE, Stroke, CABG, A fib, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if aligning knee implants based on the healthy knee, rather than the arthritic one, leads to better outcomes for individuals with osteoarthritis undergoing knee replacement surgery. Researchers will compare two groups: one using the traditional method and another using the new method based on the healthy knee, known as Native Alignment. The focus is on improving knee function and alignment after surgery. Ideal participants are those with osteoarthritis in one knee, while the other knee remains healthy. As an unphased trial, this study provides participants the chance to contribute to innovative research that could improve future knee replacement outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this knee implant alignment method is safe?

Research has shown that using kinematic alignment in knee surgeries, like those in this trial, generally leads to good results. A review of various studies found that kinematic alignment can provide stable outcomes and maintain joint function for several years. Another study found no major safety differences between new alignment methods and traditional ones for knee surgeries.

However, it is important to understand that while the results are promising, they can vary. Some studies mention that about 20% of patients may not be completely satisfied with their knee surgery results, regardless of the alignment method used. This suggests that while the treatment is generally well-received, individual experiences can differ. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Knee Implant Alignment for Osteoarthritis trial because it explores a new approach to achieving optimal knee implant positioning. Unlike the traditional method, which relies on standard measurements, this trial uses each patient's healthy knee as a template to determine the best alignment for the affected knee. This personalized technique could potentially improve implant function and longevity, offering a more tailored solution for osteoarthritis patients. By comparing this with the standard alignment method, the trial aims to discover if this customized approach leads to better outcomes.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare two alignment strategies for knee replacement surgery. Research has shown that the native alignment method, used in one arm of this trial, can lead to better results than traditional methods. Studies have found that aligning the knee based on the healthy side often results in improved function and less pain after surgery. A review of several studies found that restricted kinematic alignment, similar to native alignment, may offer slightly better outcomes than mechanical alignment. This method aims to match the knee's natural position, potentially leading to more natural movement and comfort for the patient. Overall, early findings suggest that this alignment strategy could improve recovery for people undergoing knee replacement surgery. ^{1 2 6 7 8}

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

Exclusion Criteria

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

I am younger than 21 years old.

Current smoker

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?

Group I: Participant receives bilateral knee CT preoperatively Experimental Treatment 1 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 preoperatively Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231638/

Clinical outcomes of restricted kinematic alignment versus ... Clinical outcomes of restricted kinematic alignment versus mechanical alignment in total knee arthroplasty: a meta-analysis of randomized ...

2. cureus.com cureus.com/articles/369681-exploring-knee-alignment-demystifying-traditional-and-emerging-approaches

Exploring Knee Alignment: Demystifying Traditional and ... Knee alignment plays a pivotal role in the outcomes of total knee replacement (TKR), influencing postoperative function, pain reduction, ...

3. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/122318-systematic-review-and-meta-analysis-of-long-term-outcomes-and-innovations-in-total-knee-arthroplasty-kinematic-personalized-knee-vs-conventional

Systematic review and meta-analysis of long term ... Although kinematic alignment showed slightly better clinical outcomes than mechanical alignment, the difference between the two techniques is ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X25003897

“Revolutionizing Total Knee Arthroplasty: Utilizing Three- ... The Mark Coventry Award: Does Matching the Native Coronal Plane Alignment of the Knee Improve Outcomes in Primary Total Knee Arthroplasty?

5. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/117414-two-year-outcomes-are-equal-in-kellgren-lawrence-osteoarthritis-grades-1-4-after-total-knee-arthroplasty-with-medial-pivot-implants-and-kinematic-alig

Two-Year Outcomes are Equal in Kellgren-Lawrence ... This study correlates Kellgren-Lawrence (KL) OA scores with outcomes following kinematically-aligned TKA.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2949705123000099

Review Alignment techniques in total knee arthroplasty Wide range of clinical results exist for new alignment techniques in the short term. The safe range of alignment for long-term survivorship remains unknown.

7. cureus.com cureus.com/articles/424876-functional-outcomes-and-patient-satisfaction-in-kinematic-vs-mechanical-alignment-total-knee-arthroplasty-a-systematic-review

Functional Outcomes and Patient Satisfaction in Kinematic ... Abstract. Total knee arthroplasty (TKA) is a standard treatment for end-stage osteoarthritis, yet up to 20% of patients remain dissatisfied.

8. boneandjoint.org.uk boneandjoint.org.uk/Article/10.1302/2633-1462.38.BJO-2021-0214.R1

Kinematic alignment in total knee arthroplasty: a five-year ... Kinematic alignment produces good patient outcomes and stable ligament laxity at five years for a wide range of hip-knee-ankle angles and joint line ...