X3vsN2Vac: Polyethylene Wear Study on the Triathlon Total Knee Prosthesis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac) Conventional UHMWPE inlay in a Triathlon Condyle Stabilizing (CS) fixed bearing total knee prosthesis |
Device: 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.
|
| Active Comparator: Highly cross-linked polyethylene (X3) X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
Patients with a pre-operative knee score of < 70.
-
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.
-
Need to obtain pain relief and improve function.
-
Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
-
A good nutritional state of the patient.
-
Full skeletal maturity of the patient, patients who are at least 18 years of age.
-
Patients of either sex.
Exclusion Criteria:
-
The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
-
Skeletal immaturity of the patient, patients who are less than 18 years of age.
-
Patient has a flexion contracture of 15° and more.
-
Patient has a varus/valgus contracture of 15° and more.
-
Patients with a pre-operative knee score of >70.
-
The subject has a history of total or unicompartmental reconstruction of the affected joint.
-
The subject will be operated bilaterally.
-
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).
-
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).
-
The subject has an active or suspected latent infection in or about the knee joint.
-
Osteomyelitis.
-
Sepsis.
-
Patients who will need lower limb joint replacement for another joint within one year.
-
The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
-
The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
-
The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
-
The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
-
The subject has had a knee fusion to the affected joint.
-
Female patients planning a pregnancy during the course of the study.
-
The patient is unable or unwilling to sign the Informed Consent specific to this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Orthopaedics 't Langeland Ziekenhuis Zoetermeer | Zoetermeer | Zuid Holland | Netherlands | 2725 NA |
Sponsors and Collaborators
- Stryker European Operations BV
Investigators
- Principal Investigator: H. Kaptijn, MD, 't Langeland Ziekenhuis Zoetermeer
Study Documents (Full-Text)
More Information
Publications
None provided.- K-S-039
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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 |
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 48 | 48 |
| COMPLETED | 42 | 45 |
| NOT COMPLETED | 6 | 3 |
Baseline Characteristics
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 48 | 48 | 96 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
64.42
(10.24)
|
64.31
(10.22)
|
64.36
(10.23)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
31
64.6%
|
32
66.7%
|
63
65.6%
|
| Male |
17
35.4%
|
16
33.3%
|
33
34.4%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (participants) [Number] | |||
| Netherlands |
48
100%
|
48
100%
|
96
100%
|
| BMI (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
29.32
(4.18)
|
29.61
(3.63)
|
29.46
(3.90)
|
| Indication (Count of Participants) | |||
| Osteoarthritis |
47
97.9%
|
47
97.9%
|
94
97.9%
|
| Post Traumatic Arthritis |
1
2.1%
|
1
2.1%
|
2
2.1%
|
| Smoker (Count of Participants) | |||
| Non-Smoker |
20
41.7%
|
20
41.7%
|
40
41.7%
|
| Current Cigarette Smoke |
4
8.3%
|
6
12.5%
|
10
10.4%
|
| Ex Smoker |
24
50%
|
22
45.8%
|
46
47.9%
|
Outcome Measures
| Title | Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Negative wear values represent a decrease in liner thickness (= wear). |
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 45 | 47 |
| 1 year medial wear |
-0.08
(0.35)
|
-0.03
(0.48)
|
| 1 year lateral wear |
0.22
(0.29)
|
0.22
(0.35)
|
| 1 year total wear |
-0.03
(0.20)
|
-0.00
(0.26)
|
| 2 years medial wear |
-0.14
(0.36)
|
-0.11
(0.47)
|
| 2 years lateral wear |
0.25
(0.45)
|
0.33
(0.41)
|
| 2 years total wear |
-0.06
(0.24)
|
-0.04
(0.16)
|
| 5 years medial wear |
-0.23
(0.49)
|
-0.16
(0.47)
|
| 5 years lateral wear |
0.14
(0.46)
|
0.29
(0.47)
|
| 5 years total wear |
-0.23
(0.25)
|
-0.08
(0.17)
|
| Title | Assessment of Prosthetic Migration Results After Two Years by RSA. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 46 | 47 |
| Femur migration 3 months |
0.723
(0.406)
|
0.925
(0.516)
|
| Femur migration 6 months |
0.894
(0.464)
|
0.962
(0.613)
|
| Femur migration 1 year |
0.912
(0.560)
|
1.023
(0.741)
|
| Femur migration 2 years |
0.930
(0.532)
|
1.074
(0.744)
|
| Femur migration 5 years |
1.078
(0.565)
|
1.251
(0.810)
|
| Tibia migration 3 months |
0.798
(0.685)
|
0.809
(0.616)
|
| Tibia migration 6 months |
0.873
(0.771)
|
0.903
(0.677)
|
| Tibia migration 1 year |
0.975
(0.855)
|
0.924
(0.662)
|
| Tibia migration 2 years |
1.043
(0.930)
|
0.956
(0.681)
|
| Tibia migration 5 years |
1.039
(0.759)
|
1.018
(0.673)
|
| Title | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. |
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 48 | 48 |
| Pain motion score pre-operative |
49.09
(11.84)
|
50.05
(15.72)
|
| Pain motion score 6 weeks |
68.67
(15.45)
|
66.06
(15.04)
|
| Pain motion score 3 months |
77.45
(13.82)
|
78.99
(15.57)
|
| Pain motion score 6 months |
82.52
(10.83)
|
83.17
(13.95)
|
| Pain motion score 1 year |
84.36
(10.26)
|
87.49
(9.42)
|
| Pain motion score 2 years |
82.10
(12.48)
|
83.53
(14.66)
|
| Pain motion score 5 years |
82.68
(10.11)
|
82.69
(9.89)
|
| Function score pre-op |
62.29
(15.94)
|
65.10
(14.09)
|
| Function score 6 weeks |
55.11
(12.53)
|
51.81
(18.17)
|
| Function score 3 months |
74.35
(12.10)
|
71.67
(21.00)
|
| Function score 6 months |
82.55
(13.44)
|
82.23
(13.20)
|
| Function score 1 year |
87.39
(14.21)
|
86.98
(12.82)
|
| Function score 2 years |
87.39
(13.54)
|
83.44
(16.66)
|
| Function score 5 years |
88.05
(12.34)
|
81.33
(18.93)
|
| Title | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. |
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 48 | 48 |
| Physical role functioning pre-operative |
47.40
(23.24)
|
44.81
(21.20)
|
| Physical role functioning 6 weeks |
30.45
(18.12)
|
26.99
(18.73)
|
| Physical role functioning 3 months |
48.91
(23.90)
|
47.14
(22.64)
|
| Physical role functioning 6 months |
61.04
(25.92)
|
67.84
(22.86)
|
| Physical role functioning 1 year |
71.06
(23.18)
|
69.28
(24.89)
|
| Physical role functioning 2 years |
68.75
(26.68)
|
67.80
(24.13)
|
| Physical role functioning 5 years |
69.49
(25.41)
|
66.25
(22.77)
|
| Body pain pre-operative |
41.25
(16.06)
|
39.33
(16.61)
|
| Body pain 6 weeks |
44.79
(21.13)
|
42.40
(17.46)
|
| Body pain 3 months |
58.09
(20.14)
|
60.13
(21.20)
|
| Body pain 6 months |
68.23
(21.12)
|
70.15
(21.46)
|
| Body pain 1 year |
72.33
(22.50)
|
70.65
(23.20)
|
| Body pain 2 years |
70.61
(23.95)
|
72.93
(23.17)
|
| Body pain 5 years |
76.14
(24.43)
|
69.14
(24.35)
|
| Vitality pre-operative |
60.68
(16.24)
|
61.72
(18.34)
|
| Vitality 6 weeks |
59.18
(16.70)
|
58.59
(16.52)
|
| Vitality 3 months |
68.89
(17.17)
|
62.89
(17.56)
|
| Vitality 6 months |
70.74
(17.59)
|
68.23
(17.25)
|
| Vitality 1 year |
71.33
(16.57)
|
68.62
(19.78)
|
| Vitality 2 years |
71.39
(17.15)
|
68.21
(18.33)
|
| Vitality 5 years |
70.24
(15.89)
|
69.31
(18.63)
|
| Social role functioning pre-operative |
73.18
(22.53)
|
68.23
(23.10)
|
| Social role functioning 6 weeks |
61.70
(23.97)
|
56.25
(26.02)
|
| Social role functioning 3 months |
79.89
(21.88)
|
74.22
(24.79)
|
| Social role functioning 6 months |
87.50
(17.10)
|
86.20
(21.54)
|
| Social role functioning 1 year |
86.41
(18.03)
|
86.46
(21.01)
|
| Social role functioning 2 years |
89.17
(17.20)
|
83.15
(23.20)
|
| Social role functioning 5 years |
88.99
(17.08)
|
82.10
(23.60)
|
| Emotional role functioning pre-operative |
78.47
(22.36)
|
70.14
(29.21)
|
| Emotional role functioning 6 weeks |
67.91
(29.07)
|
64.18
(34.55)
|
| Emotional role functioning 3 months |
75.18
(23.34)
|
74.65
(29.46)
|
| Emotional role functioning 6 months |
80.14
(24.10)
|
80.90
(23.20)
|
| Emotional role functioning 1 year |
84.78
(19.99)
|
79.69
(26.94)
|
| Emotional role functioning 2 years |
84.78
(22.81)
|
75.18
(27.45)
|
| Emotional role functioning 5 years |
85.53
(21.32)
|
80.74
(22.96)
|
| Mental health pre-operative |
76.98
(16.79)
|
75.83
(19.32)
|
| Mental health 6 weeks |
75.00
(18.96)
|
76.04
(18.68)
|
| Mental health 3 months |
80.98
(18.61)
|
77.08
(21.21)
|
| Mental health 6 months |
82.98
(17.74)
|
81.88
(18.02)
|
| Mental health 1 year |
84.89
(15.41)
|
78.02
(21.35)
|
| Mental health 2 years |
84.22
(13.78)
|
77.39
(19.97)
|
| Mental health 5 years |
80.60
(18.23)
|
80.00
(18.01)
|
| General health perceptions pre-op |
70.50
(17.91)
|
70.44
(17.89)
|
| General health perceptions 6 weeks |
74.09
(15.51)
|
71.13
(18.01)
|
| General health perceptions 3 months |
75.70
(17.87)
|
70.56
(19.07)
|
| General health perceptions 6 months |
73.66
(17.71)
|
70.23
(19.82)
|
| General health perceptions 1 year |
72.83
(16.06)
|
71.92
(20.59)
|
| General health perceptions 2 years |
72.50
(16.85)
|
69.63
(19.27)
|
| General health perceptions 5 years |
69.90
(16.85)
|
63.76
(21.29)
|
| Title | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. |
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 48 | 48 |
| EQ-5D descriptive pre-operative |
0.52
(0.26)
|
0.55
(0.25)
|
| EQ-5D descriptive 6 weeks |
0.65
(0.21)
|
0.65
(0.21)
|
| EQ-5D descriptive 3 months |
0.75
(0.18)
|
0.72
(0.21)
|
| EQ-5D descriptive 6 months |
0.78
(0.16)
|
0.81
(0.22)
|
| EQ-5D descriptive 1 year |
0.81
(0.19)
|
0.82
(0.24)
|
| EQ-5D descriptive 2 years |
0.85
(0.18)
|
0.84
(0.18)
|
| EQ-5D descriptive 5 years |
0.81
(0.22)
|
0.82
(0.23)
|
| VAS pre-operative |
68.27
(17.27)
|
71.60
(14.97)
|
| EQ-5D VAS 6 weeks |
74.49
(12.48)
|
71.46
(10.45)
|
| EQ-5D VAS 3 months |
76.74
(11.28)
|
75.83
(11.50)
|
| EQ-5D VAS 6 months |
81.26
(11.19)
|
78.63
(14.65)
|
| EQ-5D VAS 1 year |
81.98
(10.65)
|
80.08
(14.37)
|
| EQ-5D VAS 2 years |
81.76
(11.85)
|
79.14
(12.38)
|
| EQ-5D VAS 5 years |
79.38
(11.88)
|
76.98
(12.22)
|
| Title | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. |
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 48 | 48 |
| Activity level pre-operative |
9.29
(2.69)
|
8.98
(2.98)
|
| Activity level 6 weeks |
7.13
(0.64)
|
7.06
(1.57)
|
| Activity level 3 months |
9.17
(2.39)
|
8.73
(2.41)
|
| Activity level 6 months |
11.04
(2.67)
|
11.00
(3.23)
|
| Activity level 1 year |
11.91
(2.41)
|
11.10
(3.03)
|
| Activity level 2 years |
11.91
(2.98)
|
11.04
(3.32)
|
| Activity level 5 years |
12.17
(3.34)
|
10.87
(3.68)
|
Adverse Events
| Time Frame | Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/48 (6.3%) | 1/48 (2.1%) | ||
Serious Adverse Events |
||||
| N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/48 (45.8%) | 24/48 (50%) | ||
| Cardiac disorders | ||||
| Angina Pectoris | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Bradicardia | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Eye disorders | ||||
| Cataract | 2/48 (4.2%) | 2 | 0/48 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Hernia diafragmatica | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Gall bladder stones | 1/48 (2.1%) | 1 | 1/48 (2.1%) | 1 |
| Diarrhea for 30 days | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Immune system disorders | ||||
| Crohns Disease | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Collitis | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Infections and infestations | ||||
| Deep infection operatve site | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Infection of contralateral knee replacement | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Hemarthrosis after use of anticoagulant | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Face surgery after fall accident | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Flexion contracture operative site | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Arthrofibrosis operative site | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Instability operative site | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Carpal Tunnel Syndrome | 1/48 (2.1%) | 1 | 1/48 (2.1%) | 1 |
| Carpometacarpal joint 1 resection | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Clavicle fracture | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Ankle fracture | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Shoulder tension rupture right | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Lumbar vertebra stenosis | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Tendovaginitis stenosis | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Toxic thyroid adenoma | 0/48 (0%) | 0 | 1/48 (2.1%) | 2 |
| Breast cancer | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Bowel cancer | 1/48 (2.1%) | 1 | 1/48 (2.1%) | 1 |
| Lung cancer | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Prostate cancer | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Urothelial cancer | 2/48 (4.2%) | 2 | 0/48 (0%) | 0 |
| Nervous system disorders | ||||
| Delirium | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Renal and urinary disorders | ||||
| Stress incontinence | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Hematuria | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic obstructive pulmonary disease | 1/48 (2.1%) | 2 | 0/48 (0%) | 0 |
| Pneumonia | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Surgical and medical procedures | ||||
| Delayed wound healing operative site | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Vascular disorders | ||||
| Deep vein thrombosis | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Vascular sclerosis | 1/48 (2.1%) | 1 | 1/48 (2.1%) | 1 |
| Inguinal artery obstruction | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Arteria femoralis occlusion both sides | 1/48 (2.1%) | 1 | 0/48 (0%) | 0 |
| Vasovagal Collapse | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
| Stroke | 0/48 (0%) | 0 | 1/48 (2.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| N2Vac Polyethylene Inlay | X3 Highly Cross-linked Polyethylene | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/48 (6.3%) | 6/48 (12.5%) | ||
| Infections and infestations | ||||
| Urinary tract infection | 3/48 (6.3%) | 3 | 3/48 (6.3%) | 3 |
| Vascular disorders | ||||
| Deep vein thrombisis | 0/48 (0%) | 0 | 3/48 (6.3%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Britta von den Brincken, Clinical Study Manager |
|---|---|
| Organization | Stryker |
| Phone | +491638999202 |
| britta.vondenbrincken@stryker.com |
- K-S-039