ArthroplastyNCT02578446
Uncemented Tritanium Compared With Cemented Metal-backed Tibia Components in Total Knee Replacement
A study testing Uncemented Triathlon Tritanium CR Total Knee System and Cemented Triathlon CR Total Knee System in people with Arthroplasty and Replacement, run by Region Skane at 2 sites in 2 countries.
Trial summary
The optimal method of total knee replacement component fixation to the bone remains a challenge. The use of bone cement is considered the gold standard and is the preferred technique for most surgeons. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Uncemented Triathlon Tritanium CR Total Knee System and Cemented Triathlon CR Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2015to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient is able to understand the meaning of the study and is willing to sign the Ethics Commission (EC) approved, study specific Informed Patient Consent Form.
- Patients eligible and scheduled to undergo primary total knee replacement with any of the following indication.
- Painful and disabled knee joint resulting from osteoarthritis (Ahlbäck stage II to V)
- One or more compartments are involved.
- 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.
- The subject is a male or non-pregnant female between 40 and 75 years of age.
Who cannot join
- The subject is morbidly obese, defined as Body Mass Index (BMI) of > 37.
- Previous major knee surgery
- 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 > 3 months ago with good outcome can be included in the study).
- Patients with other severe concurrent joint involvements that can affect their outcome.
- Patient has a flexion contracture of 15° and more.
- Patient has a varus/valgus contracture of 15° and more.
Show all 15Show fewer
- The subject will be operated bilaterally.
- The subject has an active or suspected latent infection in or about the knee joint.
- Osteomyelitis
- 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.
- 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.
- Secondary exclusion criteria: when there are less than five tibia-bone markers or less than three insert markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Sweden1 site
Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital
Hässleholm, 28138
About this study
Official title: Migration and Survival of the Uncemented Tritanium Tibia Compared With the Cemented Metal-backed Tibia Using the Triathlon Cruciate Retaining (CR) Total Knee System. A Single Centre RSA Study
The optimal method of total knee replacement component fixation to the bone remains a challenge. The use of bone cement is considered the gold standard and is the preferred technique for most surgeons. However, uncemented fixation methods have been developed in an attempt to tackle problems that can be seen when cement is used. The cement-bone interlock can deform and degrade over the years and can lead to aseptic loosening, especially in young and active patients. A loosened prosthesis results in an impaired functioning and painful knee in daily life for which a revision of the prosthesis may be necessary. To prevent aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have been developed.
One of these methods is to use a highly porous metal called Tritanium®. It can improve the biologic fixation by resembling the characteristics of trabecular bone. It is expected that this surface aids bone ingrowth and to have similar or even better results concerning early fixation properties and long-term durability compared with cemented fixation. Excellent results using this highly porous Tritanium have been seen in total hip surgery already.
Read more
This single-blinded, randomized clinical trial will assess clinical and radiological outcomes including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved uncemented Triathlon Tritanium CR total knee prosthesis compared with a standard cemented Triathlon metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of each 35 patients will be included.
The primary outcome measure will be prosthetic migration after two years of the uncemented Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA. It is hypothesized that the new uncemented Tritanium prosthesis will perform at least equally good in terms of migration and clinical parameters compared with the standard cemented Triathlon.
The secondary outcome measure will be long-term (10-year) 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-year results will be used to verify the predicted long-term survival results.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Uncemented Triathlon Tritanium CR Total Knee System, Cemented Triathlon CR Total Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncemented Triathlon Tritanium CR Total Knee SystemDevice
Also called Stryker Orthopaedics
Primary Total Knee Replacement
Cemented Triathlon CR Total Knee SystemDevice
Also called Stryker Orthopaedics
Primary Total Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Uncemented Triathlon Tritanium CR | Experimental | Primary total knee replacement with Uncemented Triathlon Tritanium CR Total Knee System Receives: Device: Uncemented Triathlon Tritanium CR Total Knee System |
| Cemented Triathlon CR | Active comparator | Primary total knee replacement with Cemented Triathlon CR Total Knee System Receives: Device: Cemented Triathlon CR Total Knee System |
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: 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 posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2019
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies 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
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Sören Toksvig-Larsen, Ass Prof, Principal investigator, Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578446
- Sponsor's protocol ID
- K-I-058
- Status last verified
- Sep 2025
- First submitted
- 14 Oct 2015
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 the Uncemented Tritanium Tibia Compared With the Cemented Metal-backed Tibia Using the Triathlon Cruciate Retaining (CR) Total Knee System. A Single Centre RSA Study
- ClinicalTrials.gov ID
- NCT02578446
- Acronym / sponsor ID
- K-I-058
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Stryker Orthopaedics
- Study start
- Oct 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- 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 optimal method of total knee replacement component fixation to the bone remains a challenge. The use of bone cement is considered the gold standard and is the preferred technique for most surgeons. However, uncemented fixation methods have been developed in an attempt to tackle problems that can be seen when cement is used. The cement-bone interlock can deform and degrade over the years and can lead to aseptic loosening, especially in young and active patients. A loosened prosthesis results in an impaired functioning and painful knee in daily life for which a revision of the prosthesis may be necessary. To prevent aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have been developed.
One of these methods is to use a highly porous metal called Tritanium®. It can improve the biologic fixation by resembling the characteristics of trabecular bone. It is expected that this surface aids bone ingrowth and to have similar or even better results concerning early fixation properties and long-term durability compared with cemented fixation. Excellent results using this highly porous Tritanium have been seen in total hip surgery already.
This single-blinded, randomized clinical trial will assess clinical and radiological outcomes including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved uncemented Triathlon Tritanium CR total knee prosthesis compared with a standard cemented Triathlon metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of each 35 patients will be included.
The primary outcome measure will be prosthetic migration after two years of the uncemented Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA. It is hypothesized that the new uncemented Tritanium prosthesis will perform at least equally good in terms of migration and clinical parameters compared with the standard cemented Triathlon.
The secondary outcome measure will be long-term (10-year) 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-year 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 (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncemented Triathlon Tritanium CR | Experimental | Device: Uncemented Triathlon Tritanium CR Total Knee SystemPrimary total knee replacement with Uncemented Triathlon Tritanium CR Total Knee System |
| Cemented Triathlon CR | Active comparator | Device: Cemented Triathlon CR Total Knee SystemPrimary total knee replacement with Cemented Triathlon CR Total Knee System |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is able to understand the meaning of the study and is willing to sign the Ethics Commission (EC) approved, study specific Informed Patient Consent Form.
- Patients eligible and scheduled to undergo primary total knee replacement with any of the following indication.
- 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.
- The subject is a male or non-pregnant female between 40 and 75 years of age.
Key exclusion criteria (15 listed)
- The subject is morbidly obese, defined as Body Mass Index (BMI) of > 37.
- Previous major knee surgery
- 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 > 3 months ago with good outcome can be included in the study).
- Patients with other severe concurrent joint involvements that can affect their outcome.
- Patient has a flexion contracture of 15° and more.
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 |
|---|---|---|
| Uncemented Triathlon Tritanium CR Total Knee SystemAlso: Stryker OrthopaedicsPrimary Total Knee Replacement | Device | Uncemented Triathlon Tritanium CR |
| Cemented Triathlon CR Total Knee SystemAlso: Stryker OrthopaedicsPrimary Total Knee Replacement | Device | Cemented Triathlon CR |
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: 3 months, 1, 2, 5, 7 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
Sören Toksvig-Larsen, Ass Prof principal investigator
Department of Orthopaedics Hässleholm-Kristianstad-Ystad, Hässleholm Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncemented Triathlon Tritanium CR Total Knee System and Cemented Triathlon CR Total Knee System in people with Arthroplasty and Replacement, run by Region Skane at 2 sites in 2 countries.
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 7 inclusion and 15 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: under way, not looking for participants, 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.
Where is the study taking place?
The record lists 2 sites in Netherlands, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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.