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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TERMINATED
175 participants
OBSERVATIONAL
2012-04-30
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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3DKnee™ with e-plus Insert
Subjects who meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE) and who are candidates for a primary knee arthroplasty.
3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
Interventions
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3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
75 Years
ALL
No
Sponsors
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DJO Incorporated
INDUSTRY
Encore Medical, L.P.
INDUSTRY
Responsible Party
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Locations
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Orthopaedic Surgery Specialists
Burbank, California, United States
Orthopedic Specialists of North County
Oceanside, California, United States
Institute for Orthopaedic Surgery and Sports Medicine
Fort Myers, Florida, United States
St. Peter's Bone & Joint Surgery
City of Saint Peters, Missouri, United States
New Mexico Orthopedics
Albuquerque, New Mexico, United States
Texas Institute for Hip and Knee Surgery
Austin, Texas, United States
Countries
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Other Identifiers
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PS-706
Identifier Type: -
Identifier Source: org_study_id
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