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CompletedNCT02525588X3vsN2VacUpdated Feb 22, 2024Results posted

Polyethylene Wear Study on the Triathlon Total Knee Prosthesis

An interventional study of Triathlon CS fixed bearing total knee prosthesis in Arthroplasty, Replacement, Knee, sponsored by Stryker Orthopaedics. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.

Sponsored by Stryker Orthopaedics · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arthroplasty, Replacement, Knee
03

In context

Lead sponsor

Stryker Orthopaedics is the lead sponsor of 44 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Results

Posted Apr 7, 2020

Participant flow

Participant flow — Overall Study
MilestoneN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
Started4848
Completed4245
Not completed63
Withdrew: Death31
Withdrew: Lost to follow-up20
Withdrew: Withdrawal by subject11
Withdrew: Adverse event01

Outcome measures

PrimaryAssessment 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
Reported as:
Mean · mm
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).
mmN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
1 year medial wear-0.08 ± 0.35-0.03 ± 0.48
1 year lateral wear0.22 ± 0.290.22 ± 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 wear0.25 ± 0.450.33 ± 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 wear0.14 ± 0.460.29 ± 0.47
5 years total wear-0.23 ± 0.25-0.08 ± 0.17
SecondaryAssessment 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
Reported as:
Mean · mm
Assessment of Prosthetic Migration Results After Two Years by RSA.
mmN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
Femur migration 3 months0.723 ± 0.4060.925 ± 0.516
Femur migration 6 months0.894 ± 0.4640.962 ± 0.613
Femur migration 1 year0.912 ± 0.5601.023 ± 0.741
Femur migration 2 years0.930 ± 0.5321.074 ± 0.744
Femur migration 5 years1.078 ± 0.5651.251 ± 0.810
Tibia migration 3 months0.798 ± 0.6850.809 ± 0.616
Tibia migration 6 months0.873 ± 0.7710.903 ± 0.677
Tibia migration 1 year0.975 ± 0.8550.924 ± 0.662
Tibia migration 2 years1.043 ± 0.9300.956 ± 0.681
Tibia migration 5 years1.039 ± 0.7591.018 ± 0.673
SecondaryInvestigation 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
Reported as:
Mean · units on a scale
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
units on a scaleN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
Pain motion score pre-operative49.09 ± 11.8450.05 ± 15.72
Pain motion score 6 weeks68.67 ± 15.4566.06 ± 15.04
Pain motion score 3 months77.45 ± 13.8278.99 ± 15.57
Pain motion score 6 months82.52 ± 10.8383.17 ± 13.95
Pain motion score 1 year84.36 ± 10.2687.49 ± 9.42
Pain motion score 2 years82.10 ± 12.4883.53 ± 14.66
Pain motion score 5 years82.68 ± 10.1182.69 ± 9.89
Function score pre-op62.29 ± 15.9465.10 ± 14.09
Function score 6 weeks55.11 ± 12.5351.81 ± 18.17
Function score 3 months74.35 ± 12.1071.67 ± 21.00
Function score 6 months82.55 ± 13.4482.23 ± 13.20
Function score 1 year87.39 ± 14.2186.98 ± 12.82
Function score 2 years87.39 ± 13.5483.44 ± 16.66
Function score 5 years88.05 ± 12.3481.33 ± 18.93
SecondaryInvestigation 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
Reported as:
Mean · units on a scale
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)
units on a scaleN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
Physical role functioning pre-operative47.40 ± 23.2444.81 ± 21.20
Physical role functioning 6 weeks30.45 ± 18.1226.99 ± 18.73
Physical role functioning 3 months48.91 ± 23.9047.14 ± 22.64
Physical role functioning 6 months61.04 ± 25.9267.84 ± 22.86
Physical role functioning 1 year71.06 ± 23.1869.28 ± 24.89
Physical role functioning 2 years68.75 ± 26.6867.80 ± 24.13
Physical role functioning 5 years69.49 ± 25.4166.25 ± 22.77
Body pain pre-operative41.25 ± 16.0639.33 ± 16.61
Body pain 6 weeks44.79 ± 21.1342.40 ± 17.46
Body pain 3 months58.09 ± 20.1460.13 ± 21.20
Body pain 6 months68.23 ± 21.1270.15 ± 21.46
Body pain 1 year72.33 ± 22.5070.65 ± 23.20
Body pain 2 years70.61 ± 23.9572.93 ± 23.17
Body pain 5 years76.14 ± 24.4369.14 ± 24.35
Vitality pre-operative60.68 ± 16.2461.72 ± 18.34
Vitality 6 weeks59.18 ± 16.7058.59 ± 16.52
Vitality 3 months68.89 ± 17.1762.89 ± 17.56
Vitality 6 months70.74 ± 17.5968.23 ± 17.25
Vitality 1 year71.33 ± 16.5768.62 ± 19.78
Vitality 2 years71.39 ± 17.1568.21 ± 18.33
Vitality 5 years70.24 ± 15.8969.31 ± 18.63
Social role functioning pre-operative73.18 ± 22.5368.23 ± 23.10
Social role functioning 6 weeks61.70 ± 23.9756.25 ± 26.02
Social role functioning 3 months79.89 ± 21.8874.22 ± 24.79
Social role functioning 6 months87.50 ± 17.1086.20 ± 21.54
Social role functioning 1 year86.41 ± 18.0386.46 ± 21.01
Social role functioning 2 years89.17 ± 17.2083.15 ± 23.20
Social role functioning 5 years88.99 ± 17.0882.10 ± 23.60
Emotional role functioning pre-operative78.47 ± 22.3670.14 ± 29.21
Emotional role functioning 6 weeks67.91 ± 29.0764.18 ± 34.55
Emotional role functioning 3 months75.18 ± 23.3474.65 ± 29.46
Emotional role functioning 6 months80.14 ± 24.1080.90 ± 23.20
Emotional role functioning 1 year84.78 ± 19.9979.69 ± 26.94
Emotional role functioning 2 years84.78 ± 22.8175.18 ± 27.45
Emotional role functioning 5 years85.53 ± 21.3280.74 ± 22.96
Mental health pre-operative76.98 ± 16.7975.83 ± 19.32
Mental health 6 weeks75.00 ± 18.9676.04 ± 18.68
Mental health 3 months80.98 ± 18.6177.08 ± 21.21
Mental health 6 months82.98 ± 17.7481.88 ± 18.02
Mental health 1 year84.89 ± 15.4178.02 ± 21.35
Mental health 2 years84.22 ± 13.7877.39 ± 19.97
Mental health 5 years80.60 ± 18.2380.00 ± 18.01
General health perceptions pre-op70.50 ± 17.9170.44 ± 17.89
General health perceptions 6 weeks74.09 ± 15.5171.13 ± 18.01
General health perceptions 3 months75.70 ± 17.8770.56 ± 19.07
General health perceptions 6 months73.66 ± 17.7170.23 ± 19.82
General health perceptions 1 year72.83 ± 16.0671.92 ± 20.59
General health perceptions 2 years72.50 ± 16.8569.63 ± 19.27
General health perceptions 5 years69.90 ± 16.8563.76 ± 21.29
SecondaryInvestigation 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
Reported as:
Mean · units on a scale
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire
units on a scaleN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
EQ-5D descriptive pre-operative0.52 ± 0.260.55 ± 0.25
EQ-5D descriptive 6 weeks0.65 ± 0.210.65 ± 0.21
EQ-5D descriptive 3 months0.75 ± 0.180.72 ± 0.21
EQ-5D descriptive 6 months0.78 ± 0.160.81 ± 0.22
EQ-5D descriptive 1 year0.81 ± 0.190.82 ± 0.24
EQ-5D descriptive 2 years0.85 ± 0.180.84 ± 0.18
EQ-5D descriptive 5 years0.81 ± 0.220.82 ± 0.23
VAS pre-operative68.27 ± 17.2771.60 ± 14.97
EQ-5D VAS 6 weeks74.49 ± 12.4871.46 ± 10.45
EQ-5D VAS 3 months76.74 ± 11.2875.83 ± 11.50
EQ-5D VAS 6 months81.26 ± 11.1978.63 ± 14.65
EQ-5D VAS 1 year81.98 ± 10.6580.08 ± 14.37
EQ-5D VAS 2 years81.76 ± 11.8579.14 ± 12.38
EQ-5D VAS 5 years79.38 ± 11.8876.98 ± 12.22
SecondaryInvestigation 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
Reported as:
Mean · units on a scale
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
units on a scaleN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
Activity level pre-operative9.29 ± 2.698.98 ± 2.98
Activity level 6 weeks7.13 ± 0.647.06 ± 1.57
Activity level 3 months9.17 ± 2.398.73 ± 2.41
Activity level 6 months11.04 ± 2.6711.00 ± 3.23
Activity level 1 year11.91 ± 2.4111.10 ± 3.03
Activity level 2 years11.91 ± 2.9811.04 ± 3.32
Activity level 5 years12.17 ± 3.3410.87 ± 3.68

Adverse events

Collected over Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
N2Vac Polyethylene Inlay3/48 (6.3%)22/48 (45.8%)3/48 (6.3%)
X3 Highly Cross-linked Polyethylene1/48 (2.1%)24/48 (50%)6/48 (12.5%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
CataractEye disorders2/480/48
Urothelial cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/480/48
Deep infection operatve siteInfections and infestations0/481/48
Delayed wound healing operative siteSurgical and medical procedures1/480/48
Flexion contracture operative siteMusculoskeletal and connective tissue disorders1/480/48
Hemarthrosis after use of anticoagulantInjury, poisoning and procedural complications0/481/48
Arthrofibrosis operative siteMusculoskeletal and connective tissue disorders0/481/48
Instability operative siteMusculoskeletal and connective tissue disorders0/481/48
Angina PectorisCardiac disorders1/480/48
BradicardiaCardiac disorders1/480/48
Most frequent other events
Most frequent other events
EventN2Vac Polyethylene InlayX3 Highly Cross-linked Polyethylene
Urinary tract infectionInfections and infestations3/483/48
Deep vein thrombisisVascular disorders0/483/48

Baseline characteristics

Race or Ethnicity Baseline Measure is not captured in the Netherlands

Age, Continuous
Age, Continuous(years)N2Vac Polyethylene InlayX3 Highly Cross-linked PolyethyleneTotal
Mean64.42 ± 10.2464.31 ± 10.2264.36 ± 10.23
Sex: Female, Male
Sex: Female, Male(Participants)N2Vac Polyethylene InlayX3 Highly Cross-linked PolyethyleneTotal
Female313263
Male171633
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)N2Vac Polyethylene InlayX3 Highly Cross-linked PolyethyleneTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)N2Vac Polyethylene InlayX3 Highly Cross-linked PolyethyleneTotal
Netherlands484896
BMI
BMI(kg/m^2)N2Vac Polyethylene InlayX3 Highly Cross-linked PolyethyleneTotal
Mean29.32 ± 4.1829.61 ± 3.6329.46 ± 3.90
Indication
Indication(Participants)N2Vac Polyethylene InlayX3 Highly Cross-linked PolyethyleneTotal
Osteoarthritis474794
Post Traumatic Arthritis112
Smoker
Smoker(Participants)N2Vac Polyethylene InlayX3 Highly Cross-linked PolyethyleneTotal
Non-Smoker202040
Current Cigarette Smoke4610
Ex Smoker242246
08

Study locations

1 site
  • Department of Orthopaedics 't Langeland Ziekenhuis Zoetermeer
    Zoetermeer, Zuid Holland 2725 NA, Netherlands
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 18, 2010
  • Informed consent form · Sep 13, 2011

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02525588
Lead sponsor
Stryker Orthopaedics
Responsible party
Sponsor
First posted
Aug 17, 2015
Start date
Sep 2011
Primary completion
Mar 28, 2019
Completion
Mar 28, 2019
Results posted
Apr 7, 2020
Last update
Feb 22, 2024

Study contacts

H. Kaptijn, MD
principal investigator · 't Langeland Ziekenhuis Zoetermeer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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