Avascular Necrosis, Osteoarthritis, Post Traumatic Arthritis, Rheumatoid Arthritis, Varus Deformity
Conditions
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.
Interventions
DEVICE3DKnee
Subjects with knee osteoarthritis and willing to participate in the study
Sponsors
Encore Medical, L.P.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary 3DKnee Implant Subjects who require a knee implant that have not previously had a knee replacement in the operative knee. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Revision of Device | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Primary 3DKnee Implant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 46 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 69 years STANDARD_DEVIATION 8.7 |
| Operated Knee Left knee | 35 participants |
| Operated Knee Right knee | 36 participants |
| Primary Diagnosis Osteoarthritis | 69 participants |
| Primary Diagnosis Post-traumatic arthritis | 1 participants |
| Primary Diagnosis Varus deformity | 1 participants |
| Region of Enrollment United States | 71 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 62 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
Knee Society Function Score
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.
Time frame: 2-year
Population: The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary 3DKnee Implant | Knee Society Function Score | 76.6 Average Knee Function Score | Standard Deviation 20 |
Primary
Knee Society Score Evaluation
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).
Time frame: 2 year
Population: The number of subjects who completed their 2 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary 3DKnee Implant | Knee Society Score Evaluation | 82.9 Average Knee Rating Score | Standard Deviation 25.7 |
Primary
Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.
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.
Time frame: 2-year
Population: The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary 3DKnee Implant | Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component. | 0 participants |
Primary
Safety Assessment
Number of device related adverse events and device failures at the 2 year time frame.
Time frame: 2-year
Population: All subjects in the study were evaluated for adverse events.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary 3DKnee Implant | Safety Assessment | Revisions of device | 2 Events |
| Primary 3DKnee Implant | Safety Assessment | Number of device related adverse events | 18 Events |
| Primary 3DKnee Implant | Safety Assessment | Total number of operative site events | 40 Events |
Secondary
Oxford Knee Score
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.
Time frame: 2-year
Population: The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary 3DKnee Implant | Oxford Knee Score | 36.3 Units on a scale | Standard Deviation 14.1 |