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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary | Other | Post market study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DKnee | Device | Subjects with knee osteoarthritis and willing to participate in the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 year |
| 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. | 2-year |
| 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. | 2-year |
| Safety Assessment | Number of device related adverse events and device failures at the 2 year time frame. | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-year |
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Inclusion Criteria:
This must be a primary knee replacement on this knee.
Have knee joint disease related to one or more of the following
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:
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| Name | Affiliation | Role |
|---|---|---|
| John McAllister, M.D. | St. Peter's Bone and Joint Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Peter's Bone & Joint Surgery | City of Saint Peters | Missouri | 63376 | United States |
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| Label | URL |
|---|---|
| Sponsor Company home page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary 3DKnee Implant | Subjects who require a knee implant that have not previously had a knee replacement in the operative knee. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary 3DKnee Implant | Subjects who require a knee implant that have not previously had a knee replacement in the operative knee. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | The number of subjects who completed their 2 year visit. | Posted | Mean | Standard Deviation | Average Knee Rating Score | 2 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary 3DKnee Implant | Subjects who require a knee implant that have not previously had a knee replacement in the operative knee. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Affairs | DJO Surgical | 512-832-9500 | 6323 | jane.jacob@djosurgical.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Revision of Device |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Operated Knee | Affected knee which received the implant | Number | participants |
|
| Primary Diagnosis | Physician diagnosis of indication for receiving a total knee implant. | Number | participants |
|
|
|
| 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. | The number of subjects who completed their 2 year visit and had available data to collect for this evaluation. | Posted | Mean | Standard Deviation | Average Knee Function Score | 2-year |
|
|
|
| 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. | The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit. | Posted | Mean | Standard Deviation | Units on a scale | 2-year |
|
|
|
| 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. | The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation. | Posted | Number | participants | 2-year |
|
|
|
| Primary | Safety Assessment | Number of device related adverse events and device failures at the 2 year time frame. | All subjects in the study were evaluated for adverse events. | Posted | Number | Events | 2-year |
|
|
|
| 0 |
| 71 |
| 62 |
| 71 |
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Brain disorder | Nervous system disorders | Systematic Assessment |
|
| Device Instability | Surgical and medical procedures | Systematic Assessment | 3DKnee device became loose. |
|
| Diabetes | Endocrine disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heart Complications | Cardiac disorders | Systematic Assessment |
|
| Wound infection, rash and/or redness | Infections and infestations | Systematic Assessment |
|
| Kidney disorder | Renal and urinary disorders | Systematic Assessment |
|
| Nausea | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Numbness | Nervous system disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling | Vascular disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|