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Comparing Knee Implant Designs for Total Knee Replacement

This study is comparing two types of knee implants used in total knee replacement surgery for people with osteoarthritis. It looks at the MicroPort Evolution Medial-Pivot Knee System and the Stryker Triathlon Tritanium Knee System. Researchers want to see if one design leads to better knee movement, how your knee translates (moves forward and backward), and the initial force on your knee after surgery. You might be able to join if you are between 18 and 75 years old, need a primary total knee replacement, and are willing to give informed consent. The study aims to find out which implant design might offer better results and satisfaction for patients. The current status of this study is unclear.

Study design
This is a single-center study involving 100 adult participants. It compares two different total knee replacement devices.
What's involved
You would have measurements taken before surgery, and then again at 3 months and 12 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their surgery.

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NCT04814082

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty

Recruiting
NAAges 18–75InterventionalTreatment
LifeBridge Health
~100 participants
Updated 2025-01-22 on ClinicalTrials.gov
What's tested:MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Knee Mechanics
Measured over Pre-operative; Post-operative - 3 month and 12 month follow-up visit
+9 more outcomes measured

Conditions

Osteoarthritis, Knee
Knee Osteoarthritis
Osteoarthritis Knees Both
Osteoarthritis Knee Left
Osteoarthritis Knee Right
Knee Pain Chronic
Knee Disease
Arthropathy of Knee Joint

Explore related trials

Osteoarthritis

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • James Nace, MD · PRINCIPAL_INVESTIGATOR · LifeBridge Health

Who to contact

Martin Gesheff
[email protected]
410-601-9467
Email the study team

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Eligibility criteria

Inclusion

Subject is male or non-pregnant female aged between 18 and 75 years of age.
Subject is willing to provide informed consent to participate in the research study.
Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS)
Subject does not have a history of previous prosthetic replacement device on the operative knee.
Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.
Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.

Exclusion

Subject has a Body Mass Index (BMI) \>40
Subject has a diagnosis of avascular necrosis or inflammatory arthritis.
Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
Subject is a prisoner
Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.

What this trial measures

  • Change in Knee MechanicsPre-operative; Post-operative - 3 month and 12 month follow-up visit

    Knee flexion/extension, varus/valgus, and internal/external rotation will be measured (in degrees) and analyzed using the KneeKG system during incline and decline walking.

  • Change in Anterior/Posterior Knee TranslationPre-operative; Post-operative - 3 month and 12 month follow-up visit

    This parameter will be measured (in mm) and analyzed using the KneeKG system during incline and decline walking.

  • Change in Initial Peak Loading ForcePre-operative; Post-operative - 3 month and 12 month follow-up visit

    This parameter will be measured (in N) and analyzed using the KneeKG system during normal walking.

  • Change in Active and Passive Range of MotionPre-operative; Post-operative - 3 month and 12 month follow-up visit

    Active and passive range of motion will be measured (in degrees) using a goniometer.

  • Change in Quadriceps LagPre-operative; Post-operative - 3 month and 12 month follow-up visit

    Quadriceps lag will be measured (in degrees) in both the sitting and supine positions.

  • Change in Timed up and Go Test (TUG)Pre-operative; Post-operative - 3 month and 12 month follow-up visit

    This parameter will be measured in seconds and requires a patient to rise from a chair walk three meters and return to the chair again as quickly as possible.

  • Change in Five Times Sit to Stand TestPre-operative; Post-operative - 3 month and 12 month follow-up visit

    This parameter will be measured in seconds and will collect the amount of time it takes a patient to transfer from a seated to a standing position and back to sitting five times.

  • Change in Single Limb Stance Test for Both KneesPre-operative; Post-operative - 3 month and 12 month follow-up visit

    This parameter will be measured in seconds and will collect the amount of time a patient is able to stand unassisted on one leg.

  • Change in Timed Ascent and Descent of One Flight of Stairs TestPre-operative; Post-operative - 3 month and 12 month follow-up visit

    This parameter will be measured in seconds and will collect the amount of time it takes a patient to ascend and descend one flight of stairs (8-14 steps).

  • Change in Quadriceps Muscle StrengthPre-operative; Post-operative - 3 month and 12 month follow-up visit

    This parameter will be measured (in lbs/in) using a dynamometer for quadricep muscle strength assessment.