Arthroplasty, Knee
Conditions
Brief summary
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.
Interventions
DEVICETriathlon PSR Tibial Insert
The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 IRB/EC approved; study specific Informed Patient Consent Form. 2. Patient is a male or non-pregnant female, skeletally mature, 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 cemented total knee replacement. 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) \> 45. 2. Patient is already participating in the study for a contralateral total knee replacement. 3. Patient has a diagnosis of avascular necrosis or inflammatory arthritis. 4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. 5. Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. 6. Patient has a compromised bone stock which cannot provide adequate support to the prosthesis. 7. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). 8. Patient is diagnosed with lumbar radicular pain. 9. Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. 10. Patient has a known sensitivity to device materials. 11. Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean SF-36 Physical Component Score | pre-operative, 6 weeks, 1 year | The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol-5 Dimension (EQ-5D) | PreOp, 6 week, 1 year | The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). |
| Range of Motion | PreOp, 6 weeks, 1 year | Range of Motion evaluates how much the knee can be bent and straightened. The normal range of motion is typically 0 to 135 degrees. |
| Survivorship of Triathlon PSR Insert | 1 Year | All-cause survivorship of the Triathlon PSR Tibial Insert will be evaluated through 10 year. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triathlon PSR Tibial Insert Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
Triathlon PSR Tibial Insert: The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Censored from Analysis | 12 |
| Overall Study | Early Termination | 25 |
Baseline characteristics
| Characteristic | Triathlon PSR Tibial Insert |
|---|---|
| Age, Continuous | 65.96 years STANDARD_DEVIATION 6.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Mean SF-36 Physical Component Score
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: pre-operative, 6 weeks, 1 year
Population: Subjects data collection through 1 year as study was early terminated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon PSR Tibial Insert | Mean SF-36 Physical Component Score | Physical SF-36-Preop | 34.17 score on a scale | Standard Deviation 8.45 |
| Triathlon PSR Tibial Insert | Mean SF-36 Physical Component Score | Mental SF-36-6 weeks | 54.40 score on a scale | Standard Deviation 9.07 |
| Triathlon PSR Tibial Insert | Mean SF-36 Physical Component Score | Mental SF-36-1 year | 53.44 score on a scale | Standard Deviation 9.59 |
| Triathlon PSR Tibial Insert | Mean SF-36 Physical Component Score | Physical SF-36-6 weeks | 34.10 score on a scale | Standard Deviation 9.1 |
| Triathlon PSR Tibial Insert | Mean SF-36 Physical Component Score | Physical SF-36-1 year | 41.85 score on a scale | Standard Deviation 10.14 |
| Triathlon PSR Tibial Insert | Mean SF-36 Physical Component Score | Mental SF-36-Preop | 55.87 score on a scale | Standard Deviation 9.72 |
Secondary
EuroQol-5 Dimension (EQ-5D)
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time frame: PreOp, 6 week, 1 year
Population: Subjects data collection through 1 year as study was early terminated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon PSR Tibial Insert | EuroQol-5 Dimension (EQ-5D) | Descriptive EQ-5D-6 weeks | 0.76 score on a scale | Standard Deviation 0.11 |
| Triathlon PSR Tibial Insert | EuroQol-5 Dimension (EQ-5D) | Descriptive EQ-5D-1 year | 0.80 score on a scale | Standard Deviation 0.13 |
| Triathlon PSR Tibial Insert | EuroQol-5 Dimension (EQ-5D) | VAS EQ-5D-PreOp | 80.00 score on a scale | Standard Deviation 14.35 |
| Triathlon PSR Tibial Insert | EuroQol-5 Dimension (EQ-5D) | VAS EQ-5D-6 weeks | 81.50 score on a scale | Standard Deviation 12.5 |
| Triathlon PSR Tibial Insert | EuroQol-5 Dimension (EQ-5D) | VAS EQ-5D-1 year | 88.33 score on a scale | Standard Deviation 9.56 |
| Triathlon PSR Tibial Insert | EuroQol-5 Dimension (EQ-5D) | Descriptive EQ-5D-PreOp | 0.71 score on a scale | Standard Deviation 0.14 |
Secondary
Range of Motion
Range of Motion evaluates how much the knee can be bent and straightened. The normal range of motion is typically 0 to 135 degrees.
Time frame: PreOp, 6 weeks, 1 year
Population: Subjects data collection through 1 year as study was early terminated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon PSR Tibial Insert | Range of Motion | ROM-PreOp | 116.32 degrees | Standard Deviation 7.92 |
| Triathlon PSR Tibial Insert | Range of Motion | ROM-6 weeks | 111.08 degrees | Standard Deviation 10.7 |
| Triathlon PSR Tibial Insert | Range of Motion | ROM-1 year | 122.00 degrees | Standard Deviation 5.7 |
Secondary
Survivorship of Triathlon PSR Insert
All-cause survivorship of the Triathlon PSR Tibial Insert will be evaluated through 10 year.
Time frame: 1 Year
Population: At timepoint of termination, all enrolled and active subjects had the study device implanted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Triathlon PSR Tibial Insert | Survivorship of Triathlon PSR Insert | 25 Participants |