Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
NCT ID: NCT04814082
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-02-01
2030-07-01
Brief Summary
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Detailed Description
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Primary total knee replacement is an effective treatment for relieving pain and improving function for patients with degenerative joint disease. Recently, design of knee implants in a total knee replacement have received increased interest, particularly the medial pivot designs. Single-radius implants are designed to minimize instability throughout the functional range of movement. Medial pivot total knee designs theoretically recreate more normal knee motion when compared to single radius designs. Both implant designs are commonly used for total knee replacements. Outcomes of TKA are evaluated by multiple methods including implant/device survivorship, radiographic assessments, clinical examinations, and patient reported outcome measures (PROMS). Laboratory based gait analysis performed at a specialized research facility is not commonly conducted in patients with positive outcomes post-surgery as this is associated with high cost. There is currently not enough research comparing these two designs directly. Research is required to determine which design may provide better clinical outcomes and satisfaction with the procedure.
In addition to your normal standard clinical care, there will be scheduled pre-operative, operative, 6-week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visits.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medial-Pivot Knee System
Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.
MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
Medial Pivot Knee System
Single Radius Design Total Knee System
Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.
Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Single Radius Design Total Knee System
Interventions
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MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)
Medial Pivot Knee System
Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)
Single Radius Design Total Knee System
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Rubin Institute for Advanced Orthopedics
UNKNOWN
MicroPort Orthopedics Inc.
INDUSTRY
LifeBridge Health
OTHER
Responsible Party
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Principal Investigators
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James Nace, MD
Role: PRINCIPAL_INVESTIGATOR
LifeBridge Health
Locations
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Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1679091
Identifier Type: -
Identifier Source: org_study_id
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