The 3DKnee™ System: A Post-Market Study

Phase 4

Completed

Conditions: Osteoarthritis
Rheumatoid Arthritis
Post Traumatic Arthritis
Varus Deformity
Avascular Necrosis

Interventions: Device: 3DKnee

Registration Number: NCT00764673

Lead Sponsor: Encore Medical, L.P.

Brief Summary: The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

Inclusion Criteria

This must be a primary knee replacement on this knee.
Have knee joint disease related to one or more of the following
- degenerative joint disease, including osteoarthritis or traumatic arthritis
- 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
- Rheumatoid arthritis
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures
Patient is not pregnant
Patient must be over 18 years of age

Exclusion Criteria

If there has been a total knee replacement on this knee in the past (no revisions allowed in study)
Infection, or history of infection, acute or chronic, local or systemic
Alcoholism or other addictions
Muscular, neurological or vascular deficiencies which compromise the affected extremity
Obesity
Insufficient bone quality
Loss of ligamentous structures
High levels of physical activity
Materials sensitivity
Prisoner
Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
Patient is pregnant
Is younger than 18 years of age

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary	3DKnee	Post market study

Primary Outcome Measures

Name	Time	Method
Knee Society Score Evaluation	2 year	The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (\<70).
Knee Society Function Score	2-year	The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of \> or = to 60 on the function score is considered success.
Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.	2-year	Radiographic failure is defined as a complete radiolucent line \> 2mm wide at the bone/cement interface or a \>3 degree or \>3 mm migration (shift) of the component.
Safety Assessment	2-year	Number of device related adverse events and device failures at the 2 year time frame.

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score	2-year	Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.