ArthritisNCT04358575
Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA Study
A study testing Triathlon CS Knee System with all-polyethylene tibial components and Triathlon CS Knee System with metal-backed modular components in people with Arthritis, run by Region Skane.
Trial summary
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon CS Knee System with all-polyethylene tibial components compared to the Triathlon CS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Triathlon CS Knee System with all-polyethylene tibial components and Triathlon CS Knee System with metal-backed modular components
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. 2. Patient has a flexion contracture of 15° and more. 3. Patient has a varus/valgus contracture of 15° and more. 4. Patients with a pre-operative knee score of >70. 5. The subject has a history of total or unicompartmental reconstruction of the affected joint. 6. The subject will be operated bilaterally. 7. 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). 8. 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). 9. The subject has an active or suspected latent infection in or about the knee joint. 10. Osteomyelitis 11. Sepsis 12. Patient who is expected to need lower limb joint replacement for another joint within one year. 13. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 14. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 15. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 16. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 17. The subject has had a knee fusion to the affected joint. 18. Female patients planning a pregnancy during the course of the study. 19. The patient is unable or unwilling to sign the Informed Consent specific to this study
About this study
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon CS Knee System with all-polyethylene tibial components compared to the Triathlon CS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.
Read the detailed description
The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10 years results will be used to verify the predicted long-term survival results.
- Conditions
- Arthritis
- Being tested
- Triathlon CS Knee System with all-polyethylene tibial components, Triathlon CS Knee System with metal-backed modular components
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon CS Knee System with all-polyethylene tibial componentsDevice
Also called Stryker Orthopaedics
Primary Total Knee Replacement
Triathlon CS Knee System with metal-backed modular componentsDevice
Also called Stryker Orthopaedics
Primary Total Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| All-polyethylene tibial components | Experimental | Triathlon CS Knee System with all-polyethylene tibial components Receives: Device: Triathlon CS Knee System with all-polyethylene tibial components |
| Metal-backed modular components | Active comparator | Triathlon CS Knee System with metal-backed modular components Receives: Device: Triathlon CS Knee System with metal-backed modular components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration, measured by means of RSA
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
Measured: 2 years
Secondary outcomes (6)
Migration, measured by means of RSA
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
Measured: 10 years
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, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.
The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100.questionnaire
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of patient outcome with radiographic analysis
Plain radiographs will be obtained for assessment of fixation of the device.
Measured: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study startFeb 2014
- Primary completionOct 2014
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Single blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358575
- Sponsor's protocol ID
- Allpoly Triathlon CS
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA Study
- ClinicalTrials.gov ID
- NCT04358575
- Acronym / sponsor ID
- Allpoly Triathlon CS
- Conditions
- Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Stryker SA
- Study start
- Feb 2014 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon CS Knee System with all-polyethylene tibial components compared to the Triathlon CS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.
Detailed description
The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10 years results will be used to verify the predicted long-term survival results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All-polyethylene tibial components | Experimental | Device: Triathlon CS Knee System with all-polyethylene tibial componentsTriathlon CS Knee System with all-polyethylene tibial components |
| Metal-backed modular components | Active comparator | Device: Triathlon CS Knee System with metal-backed modular componentsTriathlon CS Knee System with metal-backed modular components |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Knee System with all-polyethylene tibial componentsAlso: Stryker OrthopaedicsPrimary Total Knee Replacement | Device | All-polyethylene tibial components |
| Triathlon CS Knee System with metal-backed modular componentsAlso: Stryker OrthopaedicsPrimary Total Knee Replacement | Device | Metal-backed modular components |
Primary outcome
Migration, measured by means of RSA
Time frame: 2 years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
6 secondary outcomes
Migration, measured by means of RSA
Time frame: 10 years
Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of clinical performance and patient outcome with the Forgotten Joint Score (FJS) patient questionnaire.
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Investigation of patient outcome with radiographic analysis
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon CS Knee System with all-polyethylene tibial components and Triathlon CS Knee System with metal-backed modular components in people with Arthritis, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Migration, measured by means of RSA (time frame: 2 years). 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 4 Sep 2025.