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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total | Active Comparator | The Smith and Nephew Total Knee System |
|
| Deuce | Experimental | The Journey Deuce Bicompartmental Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Replacement | Device | Smith and Nephew Total Knee Replacement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 2-Year Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | 2 years |
| 6-Week Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | 6 weeks |
| 4-Month Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | 4 months |
| 1-year Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Week X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard A. Engh, MD | AORI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anderson Orthopaedic Research Institute | Alexandria | Virginia | 22307 | United States |
Patients with only unicondylar arthritis were excluded and underwent unicondylar arthroplasty. Patients with arthritis in the lateral compartment were excluded and underwent total knee arthroplasty.
Patients were recruited preoperatively in a clinical setting between 2007-2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total | The Smith and Nephew Total Knee System |
| FG001 | Deuce | The Journey Deuce Bicompartmental Knee System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Preoperative osteoarthritis of the knee in medial and patellofemoral joints. BMI less than or equal to 35, Age less than or equal to 65. No previous knee surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total (Control) | The Smith and Nephew Total Knee System Total Knee Replacement: Smith and Nephew Total Knee Replacement |
| BG001 | Deuce (Study) | The Journey Deuce Bicompartmental Knee System Deuce: Smith and Nephew Bicompartmental Knee Replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 2-Year Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | Posted | Mean | Standard Deviation | units on a scale 0-100 | 2 years |
|
|
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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 | Total (Control) | The Smith and Nephew Total Knee System Total Knee Replacement: Smith and Nephew Total Knee Replacement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision knee arthroplasty | Surgical and medical procedures | Implant revised for loosening |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee stiff | Musculoskeletal and connective tissue disorders | Manipulation of the knee under anesthesia for stiffness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Knee Research Director | AORI | 7036194423 | nancylparks@gmail.com |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Deuce |
| Device |
Smith and Nephew Bicompartmental Knee Replacement |
|
| 6 weeks |
| 4-month X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported. | 4 months |
| 1-year X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported. | 1 year |
| 2-year X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported. | 2 years |
| 2-year Patient Surveys | Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good). | 2 years |
| 6-week Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | 6 weeks |
| 4-month Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | 4 months |
| 1-year Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | 1 year |
| 2-year Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | 2 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Full Range | lbs/square inches |
|
| Knee Score | Mean | Full Range | units on a scale |
|
| Participants |
|
|
| Primary | 6-Week Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | Posted | Mean | Standard Deviation | units on a scale 0-100 | 6 weeks |
|
|
|
| Primary | 4-Month Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | Posted | Mean | Standard Deviation | units on a scale 0-100 | 4 months |
|
|
|
| Primary | 1-year Knee Society Score | Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score. | Posted | Mean | Standard Deviation | units on a scale 0-100 | 1 year |
|
|
|
| Secondary | 6-Week X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | 4-month X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported. | Posted | Number | participants | 4 months |
|
|
|
| Secondary | 1-year X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported. | Posted | Number | participants | 1 year |
|
|
|
| Secondary | 2-year X-rays | Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported. | Posted | Number | participants | 2 years |
|
|
|
| Secondary | 2-year Patient Surveys | Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good). | Patients who were not revised within 2 years and were able to complete a questionnaire did so. | Posted | Mean | Full Range | units on a scale 0-48 | 2 years |
|
|
|
| Secondary | 6-week Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | Patients who were not revised and were able to make an appointment and complete the testing did so. | Posted | Mean | Standard Deviation | seconds | 6 weeks |
|
|
|
| Secondary | 4-month Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | Patients who were not revised and were able to make an appointment and complete the testing did so. | Posted | Mean | Standard Deviation | seconds | 4 months |
|
|
|
| Secondary | 1-year Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | Patients who were not revised and were able to make an appointment and complete the testing did so. | Posted | Mean | Standard Deviation | seconds | 1 year |
|
|
|
| Secondary | 2-year Functional Testing | A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result. | Patients who were not revised and were able to make an appointment and complete the testing did so. | Posted | Mean | Standard Deviation | seconds | 2 years |
|
|
|
| 1 |
| 25 |
| 3 |
| 25 |
| EG001 | Deuce (Study) | The Journey Deuce Bicompartmental Knee System Deuce: Smith and Nephew Bicompartmental Knee Replacement | 3 | 25 | 1 | 25 |
|
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| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |