Arthroplasty, Replacement, KneeX3vsN2VacNCT02525588
Polyethylene Wear Study on the Triathlon Total Knee Prosthesis
A study testing Triathlon CS fixed bearing total knee prosthesis in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Triathlon CS fixed bearing total knee prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to 28 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Orthopaedics 't Langeland Ziekenhuis Zoetermeer
Zoetermeer, South Holland, 2725 NA
About this study
Official title: Polyethylene Wear Study on the Triathlon Total Knee Prosthesis A Prospective Randomized Single Centre Roentgen Stereophotogrammetric Analysis (RSA) Study
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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Triathlon CS fixed bearing total knee prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon CS fixed bearing total knee prosthesisDevice
The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
| Study group | Role | What they receive |
|---|---|---|
| Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac) | Active comparator | Conventional UHMWPE inlay in a Triathlon Condyle Stabilizing (CS) fixed bearing total knee prosthesis Receives: Device: Triathlon CS fixed bearing total knee prosthesis |
| Highly cross-linked polyethylene (X3) | Active comparator | X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Receives: Device: Triathlon CS fixed bearing total knee prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 2 and 5 years follow-up
Secondary outcomes (5)
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.
Measured: 3 and 6 months,1, 2 and 5 years follow-up
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.
Measured: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
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.
Measured: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
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).
Measured: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
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.
Measured: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2011
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H. Kaptijn, MD, Principal investigator, 't Langeland Ziekenhuis Zoetermeer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525588
- Sponsor's protocol ID
- K-S-039
- Acronym
- X3vsN2Vac
- Status last verified
- Feb 2024
- First submitted
- 11 Jun 2015
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Wear Study on the Triathlon Total Knee Prosthesis A Prospective Randomized Single Centre Roentgen Stereophotogrammetric Analysis (RSA) Study
- ClinicalTrials.gov ID
- NCT02525588
- Acronym / sponsor ID
- X3vsN2Vac / K-S-039
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac) | Active comparator | Device: Triathlon CS fixed bearing total knee prosthesisConventional UHMWPE inlay in a Triathlon Condyle Stabilizing (CS) fixed bearing total knee prosthesis |
| Highly cross-linked polyethylene (X3) | Active comparator | Device: Triathlon CS fixed bearing total knee prosthesisX3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triathlon CS fixed bearing total knee prosthesisThe patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. | Device | Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac), Highly cross-linked polyethylene (X3) |
Primary outcome
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).
Time frame: 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.
5 secondary outcomes
Assessment of Prosthetic Migration Results After Two Years by RSA.
Time frame: 3 and 6 months,1, 2 and 5 years follow-up
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)
Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire
Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Time frame: Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Kaptijn, MD principal investigator
't Langeland Ziekenhuis Zoetermeer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon CS fixed bearing total knee prosthesis in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). (time frame: 1, 2 and 5 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.