Mechanical vs Anatomical Alignment in Knee Replacement

PV
DL
Overseen ByDaniel Lusignan, Nurse
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Maisonneuve-Rosemont Hospital
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 explores two methods for aligning knee replacements during surgery. Mechanical TKA (Total Knee Arthroplasty) uses the standard technique, while Anatomical TKA aims to mimic the knee's natural movement. The researchers aim to determine which method helps patients recover faster, experience less pain, and move more easily. Suitable participants have been recommended for a knee replacement and can give consent, but should not have other joint issues or major health problems.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance knee replacement outcomes for future patients.

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 these knee replacement techniques are safe?

Studies have shown that both anatomical and mechanical knee replacements are generally safe, though each carries specific risks. Anatomical total knee replacement may lead to infection, implant loosening, instability, and pain—common issues with knee replacements overall. Concerns also exist about the implant's longevity without loosening.

Mechanical knee replacement, the more common method, shares similar risks, including bleeding, wound complications, and potential nerve or blood vessel injuries. Infection and implant loosening can also occur with mechanical replacements.

In summary, research has found both types of knee replacements to be relatively safe. However, as with any surgery, complications can arise. Consider these risks carefully when deciding to join a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore different approaches to knee alignment in total knee arthroplasty (TKA), which could improve outcomes for patients with knee osteoarthritis. Anatomical TKA aims to replicate the natural alignment of the knee, potentially offering better joint function and comfort. On the other hand, Mechanical TKA focuses on aligning the knee components in a standardized way that may provide more consistent results. By comparing these two methods, researchers hope to determine which approach leads to better long-term satisfaction and functionality, potentially changing the standard of care for knee replacements.

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

This trial will compare two types of knee replacement surgeries: anatomical and mechanical alignment. Research has shown benefits for both approaches. Participants in the anatomical alignment arm will receive a knee replacement designed to mimic the knee's natural movement, potentially leading to better short-term results. For example, one study found that a method similar to anatomical alignment improved short-term outcomes compared to mechanical alignment. Many patients report significant pain relief and improved quality of life after surgery. Participants in the mechanical alignment arm will receive a well-established method that has demonstrated similar long-term results in patient satisfaction and function. Both approaches offer advantages, but anatomical alignment may support quicker recovery and better movement early on.36789

Who Is on the Research Team?

PA

Pascal Andre Vendittoli, MD, MSc

Principal Investigator

Research Director and surgeon

Are You a Good Fit for This Trial?

This trial is for adults who need a total knee replacement (TKA) and can give informed consent. It's not for those under 18, with infections in the leg, severe knee instability or deformity, hip replacements on the same side, substance abuse issues, mental disorders, pregnant women, allergies to implant materials, neuromuscular diseases affecting the limb or other lower limb joint damage.

Inclusion Criteria

I am eligible for a total knee replacement.
You understand what will happen during the study.
I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

I have damage to the joints in my legs.
I have a condition that affects my muscles and the nerves controlling them.
You are unable to undergo a CT-scan due to medical reasons.
See 11 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) with either mechanical or anatomical alignment using personalized instruments

Surgical procedure
1 visit (in-person)

Rehabilitation

Post-operative rehabilitation including flexion, extension, straight leg raising, and walking without assistance

1 month

Follow-up

Participants are monitored for implant stability and clinical outcomes using RSA and clinical scores

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Anatomical TKA
  • Mechanical TKA
Trial Overview The study compares two ways of aligning knee implants during surgery: 'Mechanical TKA' aligns components perpendicular to the mechanical axis; 'Anatomical TKA' aims to restore natural kinematics by matching prearthritic orientation. The goal is to see which method leads to better recovery and patient satisfaction without compromising implant longevity.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: AnatomicalExperimental Treatment1 Intervention
Group II: MechanicalActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Maisonneuve-Rosemont Hospital

Lead Sponsor

Trials
102
Recruited
38,300+

Citations

Functional and Clinical Outcomes of Total Knee ArthroplastyThis study suggests that total knee replacement surgery resulted in positive outcomes, with most patients achieving excellent or very good scores on the Knee ...
Total Knee Arthroplasty Techniques - StatPearls - NCBI - NIHPatient-reported outcomes underscore its significant impact on pain relief, functional restoration, and improved quality of life. TKA provides ...
Comparable clinical outcomes after conversion total knee ...In the HTO-to-TKA group, OKS improved from a median of 28 ([IQR]: 20–33.25) to a median of 45 ([IQR]: 42–47). In the primary TKA group, it improved from 27 ([ ...
Clinical outcomes of restricted kinematic alignment versus ...A case-control study by Ma et al. demonstrated that rKA yielded better short-term outcomes than MA in TKA [12]. However, another retrospective ...
A novel knee implant for total knee arthroplasty meets ...The OKS and WOMAC scores significantly improved postoperatively, with mean final values of 38.63 (SD 7.99, range 7–48) and 25.29 (SD 16.97, ...
a comparative study of safety notices and register outliersWe aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants.
What are the causes of failure after total knee arthroplasty?Aseptic loosening, infection, instability, patellofemoral complication, and pain are major overall causes of TKA revisions.
Complications of Total Knee Arthroplasty: Standardized ...The 22 TKA complications and adverse events include bleeding, wound complication, thromboembolic disease, neural deficit, vascular injury, medial collateral ...
Total knee arthroplasty - UpToDatePhysical assessment · Medical risk assessment · Knee imaging · Laboratory studies · Expected outcomes and informed consent · Timing of surgery ...
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