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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot

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

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Baltimore

Sinai Hospital of Baltimore, Baltimore, Maryland, United States, 21215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

LifeBridge Health,

James Nace, MD, PRINCIPAL_INVESTIGATOR, LifeBridge Health

Study Record Dates

2027-07-01