Post Market Study of the 3DKnee With E-plus Insert

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Encore Medical, L.P.
Updated on 8 November 2020
OrthoMaryland (6.7 mi away) Contact
osteoarthritis
total knee replacement
knee pain
arthropathy
traumatic arthritis
joint reconstruction

Summary

The purpose of this study is to evaluate the use and efficacy of the 3DKnee System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.

Description

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee System with vitamin E UHMWPE tibial inserts (VE).

Details
Treatment 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
Clinical Study IdentifierNCT01551472
SponsorEncore Medical, L.P.
Last Modified on8 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 40 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Traumatic Arthritis or Osteoarthritis?
Subject must be a candidate for a total primary knee replacement
Subject must have knee joint disease related to degenerative joint disease, including osteoarthritis or traumatic arthritis
Subject has a BMI 40.00 kg/m2
Subject is likely to be available for evaluation for the duration of the study
Subject is able and willing to sign the informed consent and follow study procedures
Subject is not pregnant
Subject must be between age 40 and age 75 at the time of consent

Exclusion Criteria

Subject has had a prior total or uni-knee replacement on this knee in the past (no revisions allowed in study)
Subject has avascular necrosis of the femoral condyles, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities or rheumatoid arthritis
Subject has an active cancer or is a survivor for <5 years except for squamous cell or basal cell skin cancer
Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
Subject is currently a documented substance abuser (alcohol or other addictions)
Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
Subject has a BMI > 40.00 kg/m2
Subject has loss of ligamentous structures
Subject has high levels of physical activity and is unwilling to modify levels of physical activity commensurate with recommendations
Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
Subject is a prisoner
Subject is pregnant
Subject has known materials sensitivity (to metals)
Subject is younger than 40 years (<40) or older than 75 years (>75) at the time of consent
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