Knee Arthroplasty
Conditions
Keywords
Total Knee Arthroplasty, Bicompartmental Knee Arthroplasty
Brief summary
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.
Interventions
DEVICETotal Knee Replacement
Smith and Nephew Total Knee Replacement
DEVICEDeuce
Smith and Nephew Bicompartmental Knee Replacement
Sponsors
Smith & Nephew, Inc.
Anderson Orthopaedic Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement. * Patient is 30 to 65 years of age, inclusive. * Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form. * Patient plans to be available for follow-up through 2 years postoperative.
Exclusion criteria
* Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders. * Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS). * Patient has inflammatory arthritis (e.g. rheumatoid arthritis) * Patient has BMI \> 35. * Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation. * Patient has an active infection, local or systemic. * Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.). * Patient has ACL deficiency in the study knee. * Patient has hip arthritis and/or replacement. * Patient has lateral compartment disease. * Patient is pregnant or plans to become pregnant during the course of the study. * Patient is on workman's compensation. * Patient has a known sensitivity to materials in the device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-Year Knee Society Score | 2 years | 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-Week Knee Society Score | 6 weeks | 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-Month Knee Society Score | 4 months | 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 Knee Society Score | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Patient Surveys | 2 years | 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). |
| 6-week Functional Testing | 6 weeks | 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-Week X-rays | 6 weeks | 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. |
| 1-year Functional Testing | 1 year | 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-year Functional Testing | 2 years | 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-month Functional Testing | 4 months | 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-month X-rays | 4 months | 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. |
| 1-year X-rays | 1 year | 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. |
| 2-year X-rays | 2 years | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited preoperatively in a clinical setting between 2007-2010.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Total (Control) The Smith and Nephew Total Knee System
Total Knee Replacement: Smith and Nephew Total Knee Replacement | 25 |
| Deuce (Study) The Journey Deuce Bicompartmental Knee System
Deuce: Smith and Nephew Bicompartmental Knee Replacement | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Deuce (Study) | Total | Total (Control) |
|---|---|---|---|
| Age, Continuous | 60.3 years | 59.3 years | 58.3 years |
| Body Mass Index | 28.8 lbs/square inches | 29.2 lbs/square inches | 30 lbs/square inches |
| Knee Score | 52.7 units on a scale | 51.3 units on a scale | 50 units on a scale |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 16 Participants | 35 Participants | 19 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 25 | 1 / 25 |
| serious Total, serious adverse events | 1 / 25 | 3 / 25 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 1-year Knee Society Score | 88.6 units on a scale 0-100 | Standard Deviation 14.6 |
| Deuce | 1-year Knee Society Score | 91.7 units on a scale 0-100 | Standard Deviation 9.2 |
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 2-Year Knee Society Score | 91.3 units on a scale 0-100 | Standard Deviation 9.6 |
| Deuce | 2-Year Knee Society Score | 94.2 units on a scale 0-100 | Standard Deviation 5.6 |
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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 4-Month Knee Society Score | 87.1 units on a scale 0-100 | Standard Deviation 10.2 |
| Deuce | 4-Month Knee Society Score | 91.3 units on a scale 0-100 | Standard Deviation 9 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 6-Week Knee Society Score | 75 units on a scale 0-100 | Standard Deviation 15.7 |
| Deuce | 6-Week Knee Society Score | 83.3 units on a scale 0-100 | Standard Deviation 15 |
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.
Time frame: 1 year
Population: Patients who were not revised and were able to make an appointment and complete the testing did so.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 1-year Functional Testing | 25 seconds | Standard Deviation 5.6 |
| Deuce | 1-year Functional Testing | 23.9 seconds | Standard Deviation 3.4 |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total | 1-year X-rays | 2 participants |
| Deuce | 1-year X-rays | 3 participants |
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.
Time frame: 2 years
Population: Patients who were not revised and were able to make an appointment and complete the testing did so.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 2-year Functional Testing | 25.1 seconds | Standard Deviation 2.9 |
| Deuce | 2-year Functional Testing | 23.3 seconds | Standard Deviation 3.7 |
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).
Time frame: 2 years
Population: Patients who were not revised within 2 years and were able to complete a questionnaire did so.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total | 2-year Patient Surveys | 41 units on a scale 0-48 |
| Deuce | 2-year Patient Surveys | 43 units on a scale 0-48 |
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total | 2-year X-rays | 6 participants |
| Deuce | 2-year X-rays | 4 participants |
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.
Time frame: 4 months
Population: Patients who were not revised and were able to make an appointment and complete the testing did so.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 4-month Functional Testing | 25.5 seconds | Standard Deviation 3.7 |
| Deuce | 4-month Functional Testing | 26.7 seconds | Standard Deviation 4.8 |
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.
Time frame: 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total | 4-month X-rays | 0 participants |
| Deuce | 4-month X-rays | 0 participants |
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.
Time frame: 6 weeks
Population: Patients who were not revised and were able to make an appointment and complete the testing did so.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total | 6-week Functional Testing | 36.5 seconds | Standard Deviation 10.7 |
| Deuce | 6-week Functional Testing | 35.1 seconds | Standard Deviation 15.6 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total | 6-Week X-rays | 0 participants |
| Deuce | 6-Week X-rays | 0 participants |