NCT04814082 · LifeBridge Health
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
What this study is about
Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives.
View original scientific description
Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.
Interventions
DEVICE
MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
Medial Pivot Knee System
DEVICE
Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Single Radius Design Total Knee System
Primary outcome measures
Change in Knee Mechanics
Time frame: Pre-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 Translation
Time frame: Pre-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 Force
Time frame: Pre-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 Motion
Time frame: Pre-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 Lag
Time frame: Pre-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)
Time frame: 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 Test
Time frame: Pre-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 Knees
Time frame: Pre-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 Test
Time frame: Pre-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 Strength
Time frame: Pre-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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Baltimore, Maryland
Collaborators
Rubin Institute for Advanced Orthopedics, MicroPort Orthopedics Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 22, 2025 · Source of record for eligibility and locations