Arthroplasty, Replacement, Knee
Conditions
Brief summary
The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.
Detailed description
Cases are to be enrolled at five to ten centers. The same center may be included in both arms. Conversely, a center may choose to participate in only a single arm. The enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the number of participating centers. Although a goal is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the enrollment goal, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) or Ethics Committee (EC) approval. Non-compliance of a study center may result in termination of the center's participation in the study.
Interventions
DEVICETriathlon Tritanium Knee
Cementless
DEVICETriathlon Knee
Cemented
Sponsors
Stryker Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form. 2. Patient is a male or non-pregnant female age 18-75 years at time of study device implantation. 3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). 4. Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella. 5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion criteria
1. Patient has a Body Mass Index (BMI) \> 40. 2. Patient has a diagnosis of avascular necrosis or inflammatory arthritis. 3. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. 4. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. 5. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. 6. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). 7. Patient is diagnosed with lumbar radicular pain. 8. Patient has a known sensitivity to device materials. 9. Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System | 2 years | Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship (Baseplate and Patella) | 10 years | This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination. |
| Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | 2 years | The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. |
| Compare Oxford Knee Score (OKS) Scores Between Both Groups | 2 years | The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. |
| Compare Short Form-12 (SF-12) Scores Between Both Groups | 2 years | The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state. |
Countries
United States
Participant flow
Pre-assignment details
Cohort 1: 397 participants/451 knees - 78 cases censored leaving 319 participants/373 knees. Cohort 2: 216 participants/229 knees - 82 cases censored leaving 134 participants/147 knees.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Cementless Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
Triathlon Tritanium Knee: Cementless | 319 |
| Cohort 1 Cementless Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
Triathlon Tritanium Knee: Cementless | 373 |
| Cohort 2 Cemented Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
Triathlon Knee: Cemented | 134 |
| Cohort 2 Cemented Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
Triathlon Knee: Cemented | 147 |
| Total | 973 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Censored because of inclusion/exclusion violation | 11 | 6 |
| Overall Study | Censored because study device was not implanted | 61 | 66 |
| Overall Study | Censored because surgery cancelled | 6 | 10 |
| Overall Study | Death | 12 | 0 |
| Overall Study | Lost to Follow-up | 37 | 22 |
| Overall Study | Missed final 5-year protocol visit | 0 | 32 |
| Overall Study | Revision of device | 4 | 3 |
| Overall Study | Site termination | 77 | 19 |
| Overall Study | Sponsor terminated study early | 150 | 0 |
| Overall Study | Withdrawal by Subject | 39 | 21 |
Baseline characteristics
| Characteristic | Cohort 1 Cementless | Cohort 2 Cemented | Total |
|---|---|---|---|
| Age, Continuous | 62.12 years STANDARD_DEVIATION 7.19 | 63.18 years STANDARD_DEVIATION 7.71 | 62.42 years STANDARD_DEVIATION 7.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 299 Participants | 127 Participants | 426 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 6 Participants | 18 Participants |
| Region of Enrollment United States | 319 participants | 134 participants | 453 participants |
| Sex: Female, Male Female | 155 Participants | 57 Participants | 212 Participants |
| Sex: Female, Male Male | 164 Participants | 77 Participants | 241 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 319 | 0 / 134 |
| other Total, other adverse events | 69 / 319 | 12 / 134 |
| serious Total, serious adverse events | 28 / 319 | 8 / 134 |
Outcome results
Primary
Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System
Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.
Time frame: 2 years
Population: The primary objective analysis only includes cementless, Cohort 1 participants. All Cohort 2 participants received cemented primary total knee replacements and are not included in the primary objective analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 Cementless | Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System | 373 Successful Knees |
Secondary
Compare 2011 Knee Society Score (KSS) Scores Between Both Groups
The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome.
Time frame: 2 years
Population: Participants with available data at 2 years are presented for both cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 Cementless | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Objective Knee Score | 94.90 units on a scale | Standard Deviation 6.48 |
| Cohort 1 Cementless | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Function Score KSS | 80.85 units on a scale | Standard Deviation 15.56 |
| Cohort 1 Cementless | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Patient Satisfaction Score | 35.29 units on a scale | Standard Deviation 6.76 |
| Cohort 1 Cementless | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Patient Expectation Score | 10.60 units on a scale | Standard Deviation 3.04 |
| Cohort 2 Cemented | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Patient Expectation Score | 10.06 units on a scale | Standard Deviation 2.89 |
| Cohort 2 Cemented | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Objective Knee Score | 91.75 units on a scale | Standard Deviation 9.4 |
| Cohort 2 Cemented | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Patient Satisfaction Score | 33.08 units on a scale | Standard Deviation 8.06 |
| Cohort 2 Cemented | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | Function Score KSS | 75.41 units on a scale | Standard Deviation 18.81 |
Secondary
Compare Oxford Knee Score (OKS) Scores Between Both Groups
The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Time frame: 2 years
Population: Participants with available data at 2 years are presented for both cohorts.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 Cementless | Compare Oxford Knee Score (OKS) Scores Between Both Groups | 42.59 units on a scale | Standard Deviation 5.91 |
| Cohort 2 Cemented | Compare Oxford Knee Score (OKS) Scores Between Both Groups | 40.66 units on a scale | Standard Deviation 7.79 |
Secondary
Compare Short Form-12 (SF-12) Scores Between Both Groups
The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state.
Time frame: 2 years
Population: Participants with available data at 2 years are presented for both cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 Cementless | Compare Short Form-12 (SF-12) Scores Between Both Groups | SF-12 Physical Component Score | 49.07 units on a scale | Standard Deviation 8.36 |
| Cohort 1 Cementless | Compare Short Form-12 (SF-12) Scores Between Both Groups | SF-12 Mental Component Score | 56.10 units on a scale | Standard Deviation 7.46 |
| Cohort 2 Cemented | Compare Short Form-12 (SF-12) Scores Between Both Groups | SF-12 Physical Component Score | 46.24 units on a scale | Standard Deviation 9.37 |
| Cohort 2 Cemented | Compare Short Form-12 (SF-12) Scores Between Both Groups | SF-12 Mental Component Score | 54.28 units on a scale | Standard Deviation 8.64 |
Secondary
Implant Survivorship (Baseplate and Patella)
This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination.
Time frame: 10 years
Population: Results below are for the participants/knees that were measured and analyzed at 1-year, 3-year, 5-year, 7-year postoperative on Cohort 1 cementless only as per protocol. The final 10 year was not analyzed due to early study termination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 Cementless | Implant Survivorship (Baseplate and Patella) | 3-year KM survival rate | 98.74 percentage of cementless knees |
| Cohort 1 Cementless | Implant Survivorship (Baseplate and Patella) | 1-year KM survival rate | 99.42 percentage of cementless knees |
| Cohort 1 Cementless | Implant Survivorship (Baseplate and Patella) | 5-year KM survival rate | 98.74 percentage of cementless knees |
| Cohort 1 Cementless | Implant Survivorship (Baseplate and Patella) | 7-year KM survival rate | 98.05 percentage of cementless knees |