Arthroplasty, Replacement, Knee
Conditions
Keywords
Knee, Arthroplasty, Implant
Brief summary
The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.
Detailed description
The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial. The evaluation is carried out by a prospective randomised RSA-study with Triathlon CR vs. Triathlon PS.
Interventions
DEVICETriathlon CR
Implantation of Knee Prosthesis
DEVICETriathlon PS
Implantation of Knee Prosthesis
Sponsors
Stryker Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients suffering exclusively from osteo arthritis, Stage II-V \[Ahlbäck, 1968 391\] will be operated. 2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system 3. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation. 4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.
Exclusion criteria
1. Previous major knee surgery 2. Other significant disabling problems from the muscular-skeletal system than in the knees 3. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35). 4. Patients with active or suspected infection. 5. Patients with malignancy - active malignancy. 6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy. 7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 8. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. 9. Female patients planning a pregnancy during the course of the study. 10. Patients with systemic or metabolic disorders leading to progressive bone deterioration. 11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule. 12. Patients with other severe concurrent joint involvements, which can affect their outcome. 13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis. 14. Patients under the protection of law (e.g. guardianship).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA) | 2 years follow-up | Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | pre-operative, 3 months, 1, 2, 5, 7 and 10 years | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. |
| Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-operative, 3 months, 1, 2, 5, 7 and 10 years | KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no problems or a better outcome and 0 indicating extreme problems or a worse outcome). |
| Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | 1, 2, 5, 7 and 10 years | The 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 EQ visual analogue scale (EQ 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). |
| Investigation of Patient Outcome With Radiographic Analysis | 3 months, 1, 2, 5, 7 and 10 years | Plain radiographs will be obtained for assessment of fixation of the device. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triathlon CR Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.
Triathlon CR: Implantation of Knee Prosthesis | 28 |
| Triathlon PS Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome.
Triathlon PS: Implantation of Knee Prosthesis | 30 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 4 | 3 |
| Overall Study | Did not receive randomized study device | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Triathlon CR | Triathlon PS | Total |
|---|---|---|---|
| Age, Continuous | 68.07 years STANDARD_DEVIATION 8.11 | 67.47 years STANDARD_DEVIATION 7.64 | 67.77 years STANDARD_DEVIATION 7.88 |
| Ahlbäck Classification Grade 1 | 0 Participants | 0 Participants | 0 Participants |
| Ahlbäck Classification Grade 2 | 8 Participants | 18 Participants | 26 Participants |
| Ahlbäck Classification Grade 3 | 20 Participants | 12 Participants | 32 Participants |
| Ahlbäck Classification Grade 4 | 0 Participants | 0 Participants | 0 Participants |
| Ahlbäck Classification Grade 5 | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Sweden | 28 participants | 30 participants | 58 participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 28 | 3 / 30 |
| other Total, other adverse events | 0 / 28 | 0 / 30 |
| serious Total, serious adverse events | 3 / 28 | 2 / 30 |
Outcome results
Primary
Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)
Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening.
Time frame: 2 years follow-up
Population: The number included in the analysis differs from the overall number analysed because that data were not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triathlon CR | Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA) | 0.68 mm | Standard Deviation 0.41 |
| Triathlon PS | Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA) | 0.79 mm | Standard Deviation 0.53 |
Secondary
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire
The 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 EQ visual analogue scale (EQ 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: 1, 2, 5, 7 and 10 years
Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 1 year | 0.88 units on a scale | Standard Deviation 0.15 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 2 years | 0.88 units on a scale | Standard Deviation 0.15 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 5 years | 0.85 units on a scale | Standard Deviation 0.28 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 7 years | 0.82 units on a scale | Standard Deviation 0.16 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 10 years | 0.91 units on a scale | Standard Deviation 0.16 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 1 year | 84 units on a scale | Standard Deviation 14 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 2 year | 82 units on a scale | Standard Deviation 18 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 5 year | 74 units on a scale | Standard Deviation 14 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 7 year | 78 units on a scale | Standard Deviation 15 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 10 year | 79 units on a scale | Standard Deviation 21 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 5 year | 85 units on a scale | Standard Deviation 15 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 1 year | 0.80 units on a scale | Standard Deviation 0.12 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 1 year | 83 units on a scale | Standard Deviation 13 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 2 years | 0.89 units on a scale | Standard Deviation 0.12 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 10 year | 83 units on a scale | Standard Deviation 15 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 5 years | 0.87 units on a scale | Standard Deviation 0.15 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 2 year | 84 units on a scale | Standard Deviation 16 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 7 years | 0.75 units on a scale | Standard Deviation 0.35 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 7 year | 83 units on a scale | Standard Deviation 23 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | Descriptive EQ-5D 10 years | 0.90 units on a scale | Standard Deviation 0.14 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no problems or a better outcome and 0 indicating extreme problems or a worse outcome).
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year pain | 83.77 units on a scale | Standard Deviation 14.17 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years ADL | 84.06 units on a scale | Standard Deviation 20.82 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years symptom | 82.98 units on a scale | Standard Deviation 18.58 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years ADL | 84.26 units on a scale | Standard Deviation 20.08 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years pain | 88.01 units on a scale | Standard Deviation 17.32 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years ADL | 88.53 units on a scale | Standard Deviation 18.61 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years symptom | 91.49 units on a scale | Standard Deviation 18.46 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op Sport Rec | 18.15 units on a scale | Standard Deviation 25.39 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years pain | 85.53 units on a scale | Standard Deviation 23.86 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months Sport Rec | 27.80 units on a scale | Standard Deviation 19.16 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years symptom | 84.29 units on a scale | Standard Deviation 18.3 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year Sport Rec | 38.91 units on a scale | Standard Deviation 21.84 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years pain | 86.37 units on a scale | Standard Deviation 24.03 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years Sport Rec | 41.88 units on a scale | Standard Deviation 27.45 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year symptom | 75.96 units on a scale | Standard Deviation 18.72 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years Sport Rec | 41.32 units on a scale | Standard Deviation 31.26 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years pain | 90.88 units on a scale | Standard Deviation 17.16 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years Sport Rec | 45.88 units on a scale | Standard Deviation 30.68 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op pain | 38.79 units on a scale | Standard Deviation 18.56 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years Sport Rec | 52.67 units on a scale | Standard Deviation 27.77 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op ADL | 44.16 units on a scale | Standard Deviation 16.16 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | Pre-op QOL | 21.76 units on a scale | Standard Deviation 11.55 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years symptom | 86.47 units on a scale | Standard Deviation 19.94 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months QOL | 52.25 units on a scale | Standard Deviation 17.29 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months ADL | 72.28 units on a scale | Standard Deviation 14.82 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year QOL | 68.84 units on a scale | Standard Deviation 18.05 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months pain | 70.11 units on a scale | Standard Deviation 15.51 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years QOL | 77.84 units on a scale | Standard Deviation 22.14 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year ADL | 83.64 units on a scale | Standard Deviation 17.07 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years QOL | 80.59 units on a scale | Standard Deviation 24.99 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months symptom | 65.67 units on a scale | Standard Deviation 17.13 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years QOL | 75.54 units on a scale | Standard Deviation 25.66 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years ADL | 86.61 units on a scale | Standard Deviation 14.21 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years QOL | 64.43 units on a scale | Standard Deviation 18.79 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op symptom | 47.37 units on a scale | Standard Deviation 18.19 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years QOL | 63.75 units on a scale | Standard Deviation 11.93 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op symptom | 54.66 units on a scale | Standard Deviation 20.05 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months symptom | 66.11 units on a scale | Standard Deviation 14.47 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year symptom | 76.19 units on a scale | Standard Deviation 14.99 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years symptom | 82.78 units on a scale | Standard Deviation 15.49 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years symptom | 87.80 units on a scale | Standard Deviation 12.19 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years symptom | 87.86 units on a scale | Standard Deviation 11.73 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years symptom | 84.82 units on a scale | Standard Deviation 14.42 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op pain | 43.80 units on a scale | Standard Deviation 18.57 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months pain | 71.62 units on a scale | Standard Deviation 20.2 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year pain | 79.81 units on a scale | Standard Deviation 18.92 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years pain | 87.98 units on a scale | Standard Deviation 13.75 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years pain | 90.74 units on a scale | Standard Deviation 13.84 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years pain | 88.19 units on a scale | Standard Deviation 15.61 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years pain | 88.49 units on a scale | Standard Deviation 14.47 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op ADL | 45.07 units on a scale | Standard Deviation 14.86 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months ADL | 73.68 units on a scale | Standard Deviation 18.7 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year ADL | 78.73 units on a scale | Standard Deviation 19.86 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years ADL | 83.85 units on a scale | Standard Deviation 15.62 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years ADL | 87.32 units on a scale | Standard Deviation 16.98 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years ADL | 84.20 units on a scale | Standard Deviation 19.31 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years ADL | 82.82 units on a scale | Standard Deviation 18.05 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | pre-op Sport Rec | 11.72 units on a scale | Standard Deviation 12.77 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months Sport Rec | 30.70 units on a scale | Standard Deviation 24 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year Sport Rec | 37.81 units on a scale | Standard Deviation 23.65 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years Sport Rec | 45.53 units on a scale | Standard Deviation 22.21 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years Sport Rec | 56.46 units on a scale | Standard Deviation 29.4 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years Sport Rec | 44.00 units on a scale | Standard Deviation 24.58 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 10 years Sport Rec | 43.75 units on a scale | Standard Deviation 28.37 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | Pre-op QOL | 24.57 units on a scale | Standard Deviation 14.46 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 3 months QOL | 56.47 units on a scale | Standard Deviation 22.72 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 1 year QOL | 67.63 units on a scale | Standard Deviation 24.59 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 2 years QOL | 79.02 units on a scale | Standard Deviation 19.7 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 5 years QOL | 82.55 units on a scale | Standard Deviation 18.97 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | 7 years QOL | 81.25 units on a scale | Standard Deviation 17.33 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome.
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Population: The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | pre-op assessment score | 20.43 units on a scale | Standard Deviation 8.37 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 3 months assessment score | 91.88 units on a scale | Standard Deviation 9.94 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 1 year assessment score | 95.00 units on a scale | Standard Deviation 7.61 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 2 years assessment score | 97.00 units on a scale | Standard Deviation 5.41 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 5 years assessment score | 95.47 units on a scale | Standard Deviation 9.64 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 7 years assessment score | 94.12 units on a scale | Standard Deviation 11.88 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 10 years assessment score | 95.06 units on a scale | Standard Deviation 12.57 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | pre-op function score | 49.11 units on a scale | Standard Deviation 11.71 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 3 months function score | 79.80 units on a scale | Standard Deviation 15.1 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 1 year function score | 88.54 units on a scale | Standard Deviation 17.41 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 2 years function score | 94.32 units on a scale | Standard Deviation 8.49 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 5 years function score | 87.89 units on a scale | Standard Deviation 17.27 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 7 years function score | 89.41 units on a scale | Standard Deviation 15.7 |
| Triathlon CR | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 10 years function score | 93.43 units on a scale | Standard Deviation 13.26 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 2 years function score | 89.46 units on a scale | Standard Deviation 15.89 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | pre-op assessment score | 25.5 units on a scale | Standard Deviation 7.41 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | pre-op function score | 50.67 units on a scale | Standard Deviation 12.71 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 3 months assessment score | 91.57 units on a scale | Standard Deviation 12.65 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 7 years function score | 88.00 units on a scale | Standard Deviation 16.42 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 1 year assessment score | 94.70 units on a scale | Standard Deviation 8.32 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 3 months function score | 72.17 units on a scale | Standard Deviation 17.78 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 2 years assessment score | 97.39 units on a scale | Standard Deviation 4.6 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 5 years function score | 89.79 units on a scale | Standard Deviation 17.84 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 5 years assessment score | 98.33 units on a scale | Standard Deviation 3.42 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 1 year function score | 85.00 units on a scale | Standard Deviation 16.76 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 7 years assessment score | 98.10 units on a scale | Standard Deviation 4.58 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 10 years function score | 91.39 units on a scale | Standard Deviation 13.48 |
| Triathlon PS | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | 10 years assessment score | 97.78 units on a scale | Standard Deviation 6.99 |
Secondary
Investigation of Patient Outcome With Radiographic Analysis
Plain radiographs will be obtained for assessment of fixation of the device.
Time frame: 3 months, 1, 2, 5, 7 and 10 years
Population: Plain radiographs were used for disease classification. Additional radiographs were not collected for the assessment of device fixation as the RSA analysis was used as an exact measurement of prosthesis components migration and implant fixation.