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

Stopped early

Conditions studied: Degenerative Joint Disease, Osteoarthritis, Traumatic Arthritis

In brief

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.

Key facts

Study ID

NCT01551472

Run by

Encore Medical, L.P.

People needed

175

Starts

2012-04-01

Expected to finish

2022-01-01

Last updated by the study team

2022-03-31

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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