95 Participants Needed

Surgical Alignments for Knee Arthritis

MS
MV
Overseen ByMegan VanDyke, BSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
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?

This trial tests two methods of knee replacement surgery for individuals with arthritis. Mechanical Alignment (MA) positions the new knee straight, potentially requiring extra cutting. Kinematic Alignment (KA) seeks to match the knee's natural bend with less cutting but demands greater precision. The trial includes participants undergoing knee replacement with specific equipment and who can attend follow-up visits and complete forms. As an unphased trial, it offers patients the chance to contribute to innovative surgical techniques that could enhance future knee replacement outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using chronic opioids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Kinematic Alignment (KA) and Mechanical Alignment (MA) are generally safe methods for knee replacement surgery. Studies have found no major differences in results between these techniques, indicating that patients tolerate both well.

For Kinematic Alignment, one study reported good patient outcomes and stable knee function over five years, suggesting that the procedure remains safe and effective over time. Another review found that KA often results in better knee pain relief and flexibility.

Mechanical Alignment is also considered safe. Research comparing MA and KA found no major differences in patient outcomes or walking ability, demonstrating that MA is also well-tolerated.

In summary, both KA and MA are safe choices for knee surgery. They are widely used and have been studied for their effectiveness and safety, showing good results in patients without major safety concerns.12345

Why are researchers excited about this trial?

Researchers are excited about kinematic and mechanical alignment techniques for knee arthritis because they offer a new approach to knee replacement surgery. Unlike traditional methods, which focus on a one-size-fits-all alignment, kinematic alignment customizes the alignment to mirror the patient's natural knee anatomy. This personalization aims to improve joint function and patient satisfaction. Mechanical alignment, on the other hand, emphasizes a precise, standardized alignment across patients, which could enhance the stability and longevity of the knee implant. These methods may offer better outcomes than current standard practices, potentially leading to faster recovery and improved long-term joint performance.

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

This trial will compare two surgical alignment methods for knee arthritis: Kinematic Alignment (KA) and Mechanical Alignment (MA). Research has shown that KA in knee replacement surgery often leads to better results than MA. KA typically results in higher patient satisfaction and improved knee function. Studies have found that patients receiving KA experience greater pain relief and more natural movement. For instance, one study found that KA patients scored better on tests measuring knee function, such as the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) and KSS (Knee Society Score), compared to those with MA. However, some research has found no significant difference in outcomes between the two methods. Overall, while KA may offer some benefits, both approaches can be effective for knee replacement surgery.24567

Who Is on the Research Team?

AE

Adam Edelstein, MD

Principal Investigator

Assistant Professor of Orthopaedic Surgery

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis needing replacement surgery. It's comparing two surgical methods: traditional Mechanical Alignment (MA) and the newer Kinematic Alignment (KA). Suitable participants should not have conditions that may interfere with the surgery or recovery.

Inclusion Criteria

I am having a knee replacement with a specific type of knee system.
Able to read and understand consent form and PRO instruments and willing to return for follow up visits

Exclusion Criteria

Patients receiving workers' compensation for study condition
I am unable to understand or sign the consent form.
Diagnosis or history of chronic opioid use
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Total Knee Arthroplasty (TKA) using either Mechanical Alignment (MA) or Kinematic Alignment (KA) methodology

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of KOOS-JR score

6 weeks
1 visit (in-person)

Long-term Follow-up

Participants are assessed for long-term outcomes, including the Forgotten Joint Score (FJS)

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Kinematic Alignment
  • Mechanical Alignment
Trial Overview The study tests whether aligning the new knee joint to mimic natural anatomy (KA) has better outcomes than aligning it in a neutral position (MA). The focus is on patient-rated results, addressing gaps in previous research.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Mechanical Alignment (MA)Active Control1 Intervention
Group II: Kinematic Alignment (KA)Active Control1 Intervention

Kinematic Alignment is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Kinematic Alignment for:
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Approved in United States as Kinematic Alignment for:
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Approved in Canada as Kinematic Alignment for:
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Approved in Japan as Kinematic Alignment for:
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Approved in China as Kinematic Alignment for:
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Approved in Switzerland as Kinematic Alignment for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Medacta International SA

Industry Sponsor

Trials
51
Recruited
9,100+
Founded
1999
Headquarters
Castel San Pietro, Switzerland
Known For
Orthopedic innovations
Top Products
AMIS Hip Platform, MyKA Knee Platform, NextAR Spine Platform

Published Research Related to This Trial

Kinematic alignment in total knee arthroplasty resulted in better knee joint function scores and improved flexion angles compared to mechanical alignment, based on a meta-analysis of 19 studies involving 1845 total knee arthroplasties.
Despite the differences in functional outcomes, both kinematic and mechanical alignments showed similar overall clinical outcomes and complication rates, suggesting that kinematic alignment can be a safe and effective option for knee surgery.
Kinematic and mechanical alignments in total knee arthroplasty: A meta-analysis with ≥1-year follow-up.Wang, G., Chen, L., Xu, J.[2023]
In a meta-analysis of 458 total knee arthroplasty patients, functional outcomes (measured by WOMAC and KSS scores) were similar between those who underwent kinematic alignment (KA) and those who had traditional mechanical alignment (MA), indicating that KA may not provide significant advantages in overall function post-surgery.
A slight improvement in pain scores was observed in the KA group, but no specific patient subgroups were identified that benefited more from the KA technique, suggesting that the choice of alignment method may not significantly impact long-term outcomes.
Outcome of kinematic alignment using patient-specific instrumentation versus mechanical alignment in TKA: a meta-analysis and subgroup analysis of randomised trials.Woon, JTK., Zeng, ISL., Calliess, T., et al.[2018]
In a meta-analysis of 1112 participants, kinematic alignment (KA) in total knee arthroplasty showed significantly better functional outcomes, including improved Knee Society Scores and greater knee flexion range compared to mechanical alignment (MA).
Patients who underwent KA also had a longer walking distance before discharge, indicating enhanced recovery, while other outcomes such as complication rates remained similar between the two alignment techniques.
Kinematic alignment versus mechanical alignment in primary total knee arthroplasty: an updated meta-analysis of randomized controlled trials.Liu, B., Feng, C., Tu, C.[2022]

Citations

Effectiveness of Kinematic Alignment-Total Knee Arthroplasty ...The study findings showcased that KA-TKA efficiently relieved pain and restored function in patients with valgus alignment. While patients with ...
Systematic review and meta-analysis of long term ...2. kinematic alignment showed better clinical outcome scores and better mean flexion with higher odds for pain free knee. WOMAC and KSS scores ...
Clinical outcomes of restricted kinematic alignment versus ...This study suggests that rKA provides better functional outcomes in TKA compared to MA, particularly in terms of WOMAC score and KSS.
Functional Outcomes and Patient Satisfaction in Kinematic ...KA in TKA appears to provide meaningful short- to mid-term advantages over MA, particularly in terms of functional outcomes, joint awareness, ...
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 ...
Clinical outcomes of restricted kinematic alignment versus ...Restricted Kinematic Alignment (rKA) is a well-established technique for total knee arthroplasty (TKA) that aims to approximate natural knee ...
Mechanical Alignment Vs Kalipered Kinematic Alignment ...This is called Kinemetic Alignment (KA). KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that ...
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