Clinical trial NCT01551472: Post Market Study of the 3DKnee™ With E-plus Insert
Official title: Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee™ System With Vitamin E UHMWPE Tibial Inserts (3DKnee™ With E-plus Insert)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Joint Disease
Osteoarthritis
Traumatic Arthritis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
Collaborators: name: DJO Incorporated
First posted: 2012-03-12
Enrollment: 175
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects must be diagnosed with either osteoarthritis or traumatic arthritis and be candidates for a primary total knee arthroplasty. They must also meet the indications for use for the 3DKnee system with the vitamin E tibial insert.

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the Vitamin E UHMWPE as part of the total knee system, measured by Knee Society Score Evaluation and total number of radiologic failures of the device.
timeFrame: 2 year
Secondary outcomes:
measure: Change in Knee Society Score from pre-surgery to 10 years
timeFrame: 10 year
measure: Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years
timeFrame: 10 year
measure: Change in Oxford Knee Score from pre-surgery to 10 years
timeFrame: 10 year
measure: Change in response to Quality of Life questions from pre-surgery to 6 months and each year thereafter through 10 years
timeFrame: 10 years
measure: 6. Change in pain from pre-surgery to 6 months and each year thereafter through 10 years
timeFrame: 10 years
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Orthopaedic Surgery Specialists
state: California
city: Oceanside
country: United States
facility: Orthopedic Specialists of North County
state: California
city: Fort Myers
country: United States
facility: Institute for Orthopaedic Surgery and Sports Medicine
state: Florida
city: Saint Peters
country: United States
facility: St. Peter's Bone & Joint Surgery
state: Missouri
city: Albuquerque
country: United States
facility: New Mexico Orthopedics
state: New Mexico
city: Austin
country: United States
facility: Texas Institute for Hip and Knee Surgery
state: Texas
Study officials:
References: