Arthroplasty, Replacement, Knee
Conditions
Brief summary
Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.
Detailed description
The goal of this study is to compare conventional UHMWPE with X3 highly cross-linked polyethylene in a CS fixed bearing total knee prosthesis (Triathlon Knee System: Stryker, Warsaw, USA) by means of RSA and clinical evaluation.
Interventions
DEVICETriathlon CS fixed bearing total knee prosthesis
The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form. 2. Patients with a pre-operative knee score of \< 70. 3. Patients scheduled to undergo primary total knee replacement with any of the following indication. * Painful and disabled knee joint resulting from osteoarthritis. * One or more compartments are involved. 4. Need to obtain pain relief and improve function. 5. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations. 6. A good nutritional state of the patient. 7. Full skeletal maturity of the patient, patients who are at least 18 years of age. 8. Patients of either sex.
Exclusion criteria
1. The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40. 2. Skeletal immaturity of the patient, patients who are less than 18 years of age. 3. Patient has a flexion contracture of 15° and more. 4. Patient has a varus/valgus contracture of 15° and more. 5. Patients with a pre-operative knee score of \>70. 6. The subject has a history of total or unicompartmental reconstruction of the affected joint. 7. The subject will be operated bilaterally. 8. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study). 9. Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study). 10. The subject has an active or suspected latent infection in or about the knee joint. 11. Osteomyelitis. 12. Sepsis. 13. Patients who will need lower limb joint replacement for another joint within one year. 14. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 15. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 16. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 17. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 18. The subject has had a knee fusion to the affected joint. 19. Female patients planning a pregnancy during the course of the study. 20. The patient is unable or unwilling to sign the Informed Consent specific to this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 1, 2 and 5 years follow-up | RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Prosthetic Migration Results After Two Years by RSA. | 3 and 6 months,1, 2 and 5 years follow-up | RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. This study evaluates the prosthetic migration results with focus of the two years results of the Triathlon CS Peri-Apatite coated tibial and femoral components. |
| Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one 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 Short Form Patient Questionnaire (SF-36) | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years | The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years | 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). |
| Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years | The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. |
Countries
Netherlands
Participant flow
Pre-assignment details
Four patients were included into the study but not assigned to a group as prior to surgery two patients withdraw, one surgery was cancelled due to urinary tract infection and one patient met exclusion criteria BMI\>40
Participants by arm
| Arm | Count |
|---|---|
| N2Vac Polyethylene Inlay Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis
Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. | 48 |
| X3 Highly Cross-linked Polyethylene X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis
Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. | 48 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene | Total |
|---|---|---|---|
| Age, Continuous | 64.42 years STANDARD_DEVIATION 10.24 | 64.31 years STANDARD_DEVIATION 10.22 | 64.36 years STANDARD_DEVIATION 10.23 |
| BMI | 29.32 kg/m^2 STANDARD_DEVIATION 4.18 | 29.61 kg/m^2 STANDARD_DEVIATION 3.63 | 29.46 kg/m^2 STANDARD_DEVIATION 3.9 |
| Indication Osteoarthritis | 47 Participants | 47 Participants | 94 Participants |
| Indication Post Traumatic Arthritis | 1 Participants | 1 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Netherlands | 48 participants | 48 participants | 96 participants |
| Sex: Female, Male Female | 31 Participants | 32 Participants | 63 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 33 Participants |
| Smoker Current Cigarette Smoke | 4 Participants | 6 Participants | 10 Participants |
| Smoker Ex Smoker | 24 Participants | 22 Participants | 46 Participants |
| Smoker Non-Smoker | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 48 | 1 / 48 |
| other Total, other adverse events | 3 / 48 | 6 / 48 |
| serious Total, serious adverse events | 22 / 48 | 24 / 48 |
Outcome results
Primary
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).
RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene.
Time frame: 1, 2 and 5 years follow-up
Population: Negative wear values represent a decrease in liner thickness (= wear).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 1 year lateral wear | 0.22 mm | Standard Deviation 0.29 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 2 years total wear | -0.06 mm | Standard Deviation 0.24 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 2 years medial wear | -0.14 mm | Standard Deviation 0.36 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 5 years medial wear | -0.23 mm | Standard Deviation 0.49 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 1 year total wear | -0.03 mm | Standard Deviation 0.2 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 5 years lateral wear | 0.14 mm | Standard Deviation 0.46 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 2 years lateral wear | 0.25 mm | Standard Deviation 0.45 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 5 years total wear | -0.23 mm | Standard Deviation 0.25 |
| N2Vac Polyethylene Inlay | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 1 year medial wear | -0.08 mm | Standard Deviation 0.35 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 5 years total wear | -0.08 mm | Standard Deviation 0.17 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 1 year medial wear | -0.03 mm | Standard Deviation 0.48 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 1 year lateral wear | 0.22 mm | Standard Deviation 0.35 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 1 year total wear | -0.00 mm | Standard Deviation 0.26 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 2 years medial wear | -0.11 mm | Standard Deviation 0.47 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 2 years lateral wear | 0.33 mm | Standard Deviation 0.41 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 2 years total wear | -0.04 mm | Standard Deviation 0.16 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 5 years medial wear | -0.16 mm | Standard Deviation 0.47 |
| X3 Highly Cross-linked Polyethylene | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | 5 years lateral wear | 0.29 mm | Standard Deviation 0.47 |
Secondary
Assessment of Prosthetic Migration Results After Two Years by RSA.
RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. This study evaluates the prosthetic migration results with focus of the two years results of the Triathlon CS Peri-Apatite coated tibial and femoral components.
Time frame: 3 and 6 months,1, 2 and 5 years follow-up
Population: The migration of the prosthesis components was calculated with a minimum of four RSA bone markers. In some cases only 3 RSA bone markers was used to calculate the migration, leading to inaccurate orientation matching of the bone markers. These patients are not included in the results describing the two different liner groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 3 months | 0.723 mm | Standard Deviation 0.406 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 6 months | 0.894 mm | Standard Deviation 0.464 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 1 year | 0.912 mm | Standard Deviation 0.56 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 2 years | 0.930 mm | Standard Deviation 0.532 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 5 years | 1.078 mm | Standard Deviation 0.565 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 3 months | 0.798 mm | Standard Deviation 0.685 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 6 months | 0.873 mm | Standard Deviation 0.771 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 1 year | 0.975 mm | Standard Deviation 0.855 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 2 years | 1.043 mm | Standard Deviation 0.93 |
| N2Vac Polyethylene Inlay | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 5 years | 1.039 mm | Standard Deviation 0.759 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 1 year | 0.924 mm | Standard Deviation 0.662 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 3 months | 0.925 mm | Standard Deviation 0.516 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 3 months | 0.809 mm | Standard Deviation 0.616 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 6 months | 0.962 mm | Standard Deviation 0.613 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 5 years | 1.018 mm | Standard Deviation 0.673 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 1 year | 1.023 mm | Standard Deviation 0.741 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 6 months | 0.903 mm | Standard Deviation 0.677 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 2 years | 1.074 mm | Standard Deviation 0.744 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Tibia migration 2 years | 0.956 mm | Standard Deviation 0.681 |
| X3 Highly Cross-linked Polyethylene | Assessment of Prosthetic Migration Results After Two Years by RSA. | Femur migration 5 years | 1.251 mm | Standard Deviation 0.81 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire
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: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive pre-operative | 0.52 units on a scale | Standard Deviation 0.26 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 6 weeks | 0.65 units on a scale | Standard Deviation 0.21 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 3 months | 0.75 units on a scale | Standard Deviation 0.18 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 6 months | 0.78 units on a scale | Standard Deviation 0.16 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 1 year | 0.81 units on a scale | Standard Deviation 0.19 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 2 years | 0.85 units on a scale | Standard Deviation 0.18 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 5 years | 0.81 units on a scale | Standard Deviation 0.22 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | VAS pre-operative | 68.27 units on a scale | Standard Deviation 17.27 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 6 weeks | 74.49 units on a scale | Standard Deviation 12.48 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 3 months | 76.74 units on a scale | Standard Deviation 11.28 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 6 months | 81.26 units on a scale | Standard Deviation 11.19 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 1 year | 81.98 units on a scale | Standard Deviation 10.65 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 2 years | 81.76 units on a scale | Standard Deviation 11.85 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 5 years | 79.38 units on a scale | Standard Deviation 11.88 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 6 months | 78.63 units on a scale | Standard Deviation 14.65 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive pre-operative | 0.55 units on a scale | Standard Deviation 0.25 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | VAS pre-operative | 71.60 units on a scale | Standard Deviation 14.97 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 6 weeks | 0.65 units on a scale | Standard Deviation 0.21 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 2 years | 79.14 units on a scale | Standard Deviation 12.38 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 3 months | 0.72 units on a scale | Standard Deviation 0.21 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 6 weeks | 71.46 units on a scale | Standard Deviation 10.45 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 6 months | 0.81 units on a scale | Standard Deviation 0.22 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 1 year | 80.08 units on a scale | Standard Deviation 14.37 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 1 year | 0.82 units on a scale | Standard Deviation 0.24 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 3 months | 75.83 units on a scale | Standard Deviation 11.5 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 2 years | 0.84 units on a scale | Standard Deviation 0.18 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D VAS 5 years | 76.98 units on a scale | Standard Deviation 12.22 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | EQ-5D descriptive 5 years | 0.82 units on a scale | Standard Deviation 0.23 |
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: one for pain, range of motion (ROM) and joint stability, and one 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, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score pre-operative | 49.09 units on a scale | Standard Deviation 11.84 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 6 weeks | 68.67 units on a scale | Standard Deviation 15.45 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 3 months | 77.45 units on a scale | Standard Deviation 13.82 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 6 months | 82.52 units on a scale | Standard Deviation 10.83 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 1 year | 84.36 units on a scale | Standard Deviation 10.26 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 2 years | 82.10 units on a scale | Standard Deviation 12.48 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 5 years | 82.68 units on a scale | Standard Deviation 10.11 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score pre-op | 62.29 units on a scale | Standard Deviation 15.94 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 6 weeks | 55.11 units on a scale | Standard Deviation 12.53 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 3 months | 74.35 units on a scale | Standard Deviation 12.1 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 6 months | 82.55 units on a scale | Standard Deviation 13.44 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 1 year | 87.39 units on a scale | Standard Deviation 14.21 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 2 years | 87.39 units on a scale | Standard Deviation 13.54 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 5 years | 88.05 units on a scale | Standard Deviation 12.34 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 6 months | 82.23 units on a scale | Standard Deviation 13.2 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score pre-operative | 50.05 units on a scale | Standard Deviation 15.72 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score pre-op | 65.10 units on a scale | Standard Deviation 14.09 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 6 weeks | 66.06 units on a scale | Standard Deviation 15.04 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 2 years | 83.44 units on a scale | Standard Deviation 16.66 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 3 months | 78.99 units on a scale | Standard Deviation 15.57 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 6 weeks | 51.81 units on a scale | Standard Deviation 18.17 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 6 months | 83.17 units on a scale | Standard Deviation 13.95 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 1 year | 86.98 units on a scale | Standard Deviation 12.82 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 1 year | 87.49 units on a scale | Standard Deviation 9.42 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 3 months | 71.67 units on a scale | Standard Deviation 21 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 2 years | 83.53 units on a scale | Standard Deviation 14.66 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Function score 5 years | 81.33 units on a scale | Standard Deviation 18.93 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | Pain motion score 5 years | 82.69 units on a scale | Standard Deviation 9.89 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 3 months | 9.17 units on a scale | Standard Deviation 2.39 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 1 year | 11.91 units on a scale | Standard Deviation 2.41 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 6 weeks | 7.13 units on a scale | Standard Deviation 0.64 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 2 years | 11.91 units on a scale | Standard Deviation 2.98 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 6 months | 11.04 units on a scale | Standard Deviation 2.67 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 5 years | 12.17 units on a scale | Standard Deviation 3.34 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level pre-operative | 9.29 units on a scale | Standard Deviation 2.69 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 5 years | 10.87 units on a scale | Standard Deviation 3.68 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level pre-operative | 8.98 units on a scale | Standard Deviation 2.98 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 6 weeks | 7.06 units on a scale | Standard Deviation 1.57 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 3 months | 8.73 units on a scale | Standard Deviation 2.41 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 6 months | 11.00 units on a scale | Standard Deviation 3.23 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 1 year | 11.10 units on a scale | Standard Deviation 3.03 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | Activity level 2 years | 11.04 units on a scale | Standard Deviation 3.32 |
Secondary
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; 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, 3 and 6 months, 1, 2 and 5 years
Population: Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 6 weeks | 75.00 units on a scale | Standard Deviation 18.96 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning pre-operative | 47.40 units on a scale | Standard Deviation 23.24 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 6 weeks | 30.45 units on a scale | Standard Deviation 18.12 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 3 months | 48.91 units on a scale | Standard Deviation 23.9 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 6 months | 61.04 units on a scale | Standard Deviation 25.92 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 1 year | 71.06 units on a scale | Standard Deviation 23.18 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 2 years | 68.75 units on a scale | Standard Deviation 26.68 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 5 years | 69.49 units on a scale | Standard Deviation 25.41 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain pre-operative | 41.25 units on a scale | Standard Deviation 16.06 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 6 weeks | 44.79 units on a scale | Standard Deviation 21.13 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 3 months | 58.09 units on a scale | Standard Deviation 20.14 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 6 months | 68.23 units on a scale | Standard Deviation 21.12 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 1 year | 72.33 units on a scale | Standard Deviation 22.5 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 2 years | 70.61 units on a scale | Standard Deviation 23.95 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 5 years | 76.14 units on a scale | Standard Deviation 24.43 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality pre-operative | 60.68 units on a scale | Standard Deviation 16.24 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 6 weeks | 59.18 units on a scale | Standard Deviation 16.7 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 3 months | 68.89 units on a scale | Standard Deviation 17.17 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 6 months | 70.74 units on a scale | Standard Deviation 17.59 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 1 year | 71.33 units on a scale | Standard Deviation 16.57 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 2 years | 71.39 units on a scale | Standard Deviation 17.15 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 5 years | 70.24 units on a scale | Standard Deviation 15.89 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning pre-operative | 73.18 units on a scale | Standard Deviation 22.53 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 6 weeks | 61.70 units on a scale | Standard Deviation 23.97 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 3 months | 79.89 units on a scale | Standard Deviation 21.88 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 6 months | 87.50 units on a scale | Standard Deviation 17.1 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 1 year | 86.41 units on a scale | Standard Deviation 18.03 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 2 years | 89.17 units on a scale | Standard Deviation 17.2 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 5 years | 88.99 units on a scale | Standard Deviation 17.08 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning pre-operative | 78.47 units on a scale | Standard Deviation 22.36 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 6 weeks | 67.91 units on a scale | Standard Deviation 29.07 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 3 months | 75.18 units on a scale | Standard Deviation 23.34 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 6 months | 80.14 units on a scale | Standard Deviation 24.1 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 1 year | 84.78 units on a scale | Standard Deviation 19.99 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 2 years | 84.78 units on a scale | Standard Deviation 22.81 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 5 years | 85.53 units on a scale | Standard Deviation 21.32 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health pre-operative | 76.98 units on a scale | Standard Deviation 16.79 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 5 years | 69.90 units on a scale | Standard Deviation 16.85 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 3 months | 80.98 units on a scale | Standard Deviation 18.61 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 6 months | 82.98 units on a scale | Standard Deviation 17.74 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 1 year | 84.89 units on a scale | Standard Deviation 15.41 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 2 years | 84.22 units on a scale | Standard Deviation 13.78 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 5 years | 80.60 units on a scale | Standard Deviation 18.23 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions pre-op | 70.50 units on a scale | Standard Deviation 17.91 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 6 weeks | 74.09 units on a scale | Standard Deviation 15.51 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 3 months | 75.70 units on a scale | Standard Deviation 17.87 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 6 months | 73.66 units on a scale | Standard Deviation 17.71 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 1 year | 72.83 units on a scale | Standard Deviation 16.06 |
| N2Vac Polyethylene Inlay | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 2 years | 72.50 units on a scale | Standard Deviation 16.85 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 6 weeks | 76.04 units on a scale | Standard Deviation 18.68 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 6 months | 86.20 units on a scale | Standard Deviation 21.54 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning pre-operative | 44.81 units on a scale | Standard Deviation 21.2 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 2 years | 69.63 units on a scale | Standard Deviation 19.27 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 6 weeks | 26.99 units on a scale | Standard Deviation 18.73 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 1 year | 86.46 units on a scale | Standard Deviation 21.01 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 3 months | 47.14 units on a scale | Standard Deviation 22.64 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 3 months | 77.08 units on a scale | Standard Deviation 21.21 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 6 months | 67.84 units on a scale | Standard Deviation 22.86 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 2 years | 83.15 units on a scale | Standard Deviation 23.2 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 1 year | 69.28 units on a scale | Standard Deviation 24.89 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 6 weeks | 71.13 units on a scale | Standard Deviation 18.01 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 2 years | 67.80 units on a scale | Standard Deviation 24.13 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 5 years | 82.10 units on a scale | Standard Deviation 23.6 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Physical role functioning 5 years | 66.25 units on a scale | Standard Deviation 22.77 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 6 months | 81.88 units on a scale | Standard Deviation 18.02 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain pre-operative | 39.33 units on a scale | Standard Deviation 16.61 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning pre-operative | 70.14 units on a scale | Standard Deviation 29.21 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 6 weeks | 42.40 units on a scale | Standard Deviation 17.46 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 1 year | 71.92 units on a scale | Standard Deviation 20.59 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 3 months | 60.13 units on a scale | Standard Deviation 21.2 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 6 weeks | 64.18 units on a scale | Standard Deviation 34.55 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 6 months | 70.15 units on a scale | Standard Deviation 21.46 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 1 year | 78.02 units on a scale | Standard Deviation 21.35 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 1 year | 70.65 units on a scale | Standard Deviation 23.2 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 3 months | 74.65 units on a scale | Standard Deviation 29.46 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 2 years | 72.93 units on a scale | Standard Deviation 23.17 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 3 months | 70.56 units on a scale | Standard Deviation 19.07 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Body pain 5 years | 69.14 units on a scale | Standard Deviation 24.35 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 6 months | 80.90 units on a scale | Standard Deviation 23.2 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality pre-operative | 61.72 units on a scale | Standard Deviation 18.34 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 2 years | 77.39 units on a scale | Standard Deviation 19.97 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 6 weeks | 58.59 units on a scale | Standard Deviation 16.52 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 1 year | 79.69 units on a scale | Standard Deviation 26.94 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 3 months | 62.89 units on a scale | Standard Deviation 17.56 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 5 years | 63.76 units on a scale | Standard Deviation 21.29 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 6 months | 68.23 units on a scale | Standard Deviation 17.25 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 2 years | 75.18 units on a scale | Standard Deviation 27.45 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 1 year | 68.62 units on a scale | Standard Deviation 19.78 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health 5 years | 80.00 units on a scale | Standard Deviation 18.01 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 2 years | 68.21 units on a scale | Standard Deviation 18.33 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Emotional role functioning 5 years | 80.74 units on a scale | Standard Deviation 22.96 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Vitality 5 years | 69.31 units on a scale | Standard Deviation 18.63 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions 6 months | 70.23 units on a scale | Standard Deviation 19.82 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning pre-operative | 68.23 units on a scale | Standard Deviation 23.1 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Mental health pre-operative | 75.83 units on a scale | Standard Deviation 19.32 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 6 weeks | 56.25 units on a scale | Standard Deviation 26.02 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | General health perceptions pre-op | 70.44 units on a scale | Standard Deviation 17.89 |
| X3 Highly Cross-linked Polyethylene | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) | Social role functioning 3 months | 74.22 units on a scale | Standard Deviation 24.79 |