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

Encore Medical

Status: Terminated

Conditions: Traumatic Arthritis; Osteoarthritis; Degenerative Joint Disease

Treatments: Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts

Study type: Observational

Funder types: Industry

Identifiers

NCT01551472

PS-706

Details and patient eligibility

About

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.

Full 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).

Enrollment: 175 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Trial design

175 participants in 1 patient group

3DKnee™ with e-plus Insert

Description:

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.

Treatment:

Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts