Complications; Arthroplasty, MechanicalNCT02924961
Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design
A study testing Triathlon PS total knee system with mobile-bearing and Triathlon PS total knee system with fixed-bearing in people with Complications; Arthroplasty, Mechanical and Aseptic Loosening, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications; Arthroplasty, Mechanical, Aseptic Loosening
- What is being tested?
- Triathlon PS total knee system with mobile-bearing and Triathlon PS total knee system with fixed-bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2008to Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (minimum age of 18 years old, no maximum age limit) is diagnosed with osteoarthritis or rheumatoid arthritis and requires primary arthroplasty.
- Patient is capable of giving informed consent and expressing a willingness to comply with this study
- Patient has no major deformities (i.e. sagittal and coronal deformities are less then 15 degrees)
- The ability to perform a lunge and step-up motion without the help of bars or a cane.
- No or slight pain during activity according to the Knee Society Pain Score
Who cannot join
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- The individual has a functional impairment of any other lower extremity joint besides the operated knee
- Patient has a flexion contracture of 15° and more
- Patient has a varus/valgus contracture of 15° and more
- Patients requiring revision arthroplasty
- The patient does not understand the Dutch or English language good enough to participate.
- The use of walking aids
- The inability to walk more than 500 meters
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Orthopaedics, Leiden University Medical Center
Leiden, 2300RC
About this study
The goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.
Read the detailed description
The goal of this study is to perform a kinematic evaluation of a MB and FB knee prosthesis designs (Triathlon, Stryker, USA), by means of fluoroscopy and RSA and compare the different designs. The findings of this study will contribute to improve total knee designs and improve rehabilitation strategies.
Objectives:
- To evaluate if there is micromotion of the prosthesis with respect to the bone and if there is a different migration pattern between the designs.
- To assess and compare the in vivo kinematic patterns of the knee designs by means of fluoroscopy. This will be done on a subset of the patients (the first 20 patients able to perform step-up and lunge motions 6 months post-operatively in a controlled manner without the use of bars and walk more than 1 km)
- To evaluate if the polyethylene bearing in the mobile bearing is rotating and if this changes over time.
- Results of the RSA study will be used to correlate the kinematic parameters (fluoroscopy) with the migration results in order to identify factors of risk for the survival of total knee prostheses.
- Being tested
- Triathlon PS total knee system with mobile-bearing, Triathlon PS total knee system with fixed-bearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon PS total knee system with mobile-bearingDevice
Also called Stryker Orthopaedics
Triathlon PS total knee system with fixed-bearingDevice
Also called Stryker Orthopaedics
| Study group | Role | What they receive |
|---|---|---|
| Triathlon Mobile-bearing | Experimental | Primary total knee replacement with cemented Triathlon posterior stabilized mobile-bearing Receives: Device: Triathlon PS total knee system with mobile-bearing |
| Triathlon Fixed-bearing | Active comparator | Primary total knee replacement with cemented Triathlon posterior stabilized fixed-bearing Receives: Device: Triathlon PS total knee system with fixed-bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration, measured by means of RSA on the first 20 patients (fluoroscopy subset)
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
Measured: First or second day postoperatively, 6 months, 1 year
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: First or second day postoperatively, 6 months, 1 year and annually thereafter up to 20 years
Assessment of the knee flexion range by means of fluoroscopy during step-up motions
Patients will be asked to perform three step-up motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is knee flexion range (degrees).
Measured: 6 months and 13 months postoperatively
Assessment of the axial rotation range of femoral component by means of fluoroscopy during step-up motions
Patients will be asked to perform three step-up motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is axial rotation range of femoral component (degrees).
Measured: 6 months and 13 months postoperatively
Assessment of the knee flexion range by means of fluoroscopy during lunge motions
Patients will be asked to perform three lunge motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is knee flexion range (degrees).
Measured: 6 months and 13 months postoperatively
Assessment of the axial rotation range of femoral component by means of fluoroscopy during lunge motions
Patients will be asked to perform three lunge motions (height 18 cm) with bare feet in front of a flat panel fluoroscope. Outcome measurement is axial rotation range of femoral component (degrees).
Measured: 6 months and 13 months postoperatively
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: Within 3 months prior to surgery, 6 months postoperatively, 1 year and and annually thereafter up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startApr 2008
- Primary completionJul 2011
- Study completionFeb 2016
Why it stopped: Mobile-bearing insert dislocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Arthroplasty, MechanicalStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, R.G.H.H. Nelissen, Leiden University Medical Center
- Investigators
- R.G.H.H. Nelissen, MD, PhD, Principal investigator, Head of Department of Orthopaedics, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924961
- Sponsor's protocol ID
- P07.205
- Status last verified
- Mar 2018
- First submitted
- 21 Sep 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: IPD analysis is scheduled
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopic and RSA Evaluation of the Triathlon Total Knee Prosthetic Design
- ClinicalTrials.gov ID
- NCT02924961
- Acronym / sponsor ID
- P07.205
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Mobile-bearing insert dislocation
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- Apr 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Oct 2016 (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 goal of this study is to compare the fixed bearing (FB) Triathlon knee (Stryker, USA) and the mobile bearing (MB) Triathlon knee (Stryker, USA) and study the effect of implant design on kinematics and micromotion. During two tasks the kinematics measured with fluoroscopy (kinematics and movement of the polyethylene bearing). Roentgen Stereophotogrammetric Analysis (RSA) will be used to evaluate micromotion between prosthesis and the bone for the MB and FB Triathlon knee.
Detailed description
The goal of this study is to perform a kinematic evaluation of a MB and FB knee prosthesis designs (Triathlon, Stryker, USA), by means of fluoroscopy and RSA and compare the different designs. The findings of this study will contribute to improve total knee designs and improve rehabilitation strategies.
Objectives:
- To evaluate if there is micromotion of the prosthesis with respect to the bone and if there is a different migration pattern between the designs.
- To assess and compare the in vivo kinematic patterns of the knee designs by means of fluoroscopy. This will be done on a subset of the patients (the first 20 patients able to perform step-up and lunge motions 6 months post-operatively in a controlled manner without the use of bars and walk more than 1 km)
- To evaluate if the polyethylene bearing in the mobile bearing is rotating and if this changes over time.
- Results of the RSA study will be used to correlate the kinematic parameters (fluoroscopy) with the migration results in order to identify factors of risk for the survival of total knee prostheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triathlon Mobile-bearing | Experimental | Device: Triathlon PS total knee system with mobile-bearingPrimary total knee replacement with cemented Triathlon posterior stabilized mobile-bearing |
| Triathlon Fixed-bearing | Active comparator | Device: Triathlon PS total knee system with fixed-bearingPrimary total knee replacement with cemented Triathlon posterior stabilized fixed-bearing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient (minimum age of 18 years old, no maximum age limit) is diagnosed with osteoarthritis or rheumatoid arthritis and requires primary arthroplasty.
- Patient is capable of giving informed consent and expressing a willingness to comply with this study
- Patient has no major deformities (i.e. sagittal and coronal deformities are less then 15 degrees)
- The ability to perform a lunge and step-up motion without the help of bars or a cane.
- No or slight pain during activity according to the Knee Society Pain Score
Key exclusion criteria (8 listed)
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- The individual has a functional impairment of any other lower extremity joint besides the operated knee
- Patient has a flexion contracture of 15° and more
- Patient has a varus/valgus contracture of 15° and more
- Patients requiring revision arthroplasty
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 PS total knee system with mobile-bearingAlso: Stryker Orthopaedics | Device | Triathlon Mobile-bearing |
| Triathlon PS total knee system with fixed-bearingAlso: Stryker Orthopaedics | Device | Triathlon Fixed-bearing |
Primary outcome
Migration, measured by means of RSA on the first 20 patients (fluoroscopy subset)
Time frame: First or second day postoperatively, 6 months, 1 year
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: First or second day postoperatively, 6 months, 1 year and annually thereafter up to 20 years
Assessment of the knee flexion range by means of fluoroscopy during step-up motions
Time frame: 6 months and 13 months postoperatively
Assessment of the axial rotation range of femoral component by means of fluoroscopy during step-up motions
Time frame: 6 months and 13 months postoperatively
Assessment of the knee flexion range by means of fluoroscopy during lunge motions
Time frame: 6 months and 13 months postoperatively
Assessment of the axial rotation range of femoral component by means of fluoroscopy during lunge motions
Time frame: 6 months and 13 months postoperatively
Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)
Time frame: Within 3 months prior to surgery, 6 months postoperatively, 1 year and and annually thereafter up to 20 years
Results and safety
The study was stopped early (reason given: Mobile-bearing insert dislocation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: Undecided. IPD analysis is scheduled
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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.
R.G.H.H. Nelissen, MD, PhD principal investigator
Head of Department of Orthopaedics, Leiden University Medical Center
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 PS total knee system with mobile-bearing and Triathlon PS total knee system with fixed-bearing in people with Complications; Arthroplasty, Mechanical and Aseptic Loosening, run by Leiden University Medical Center 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Mar 2018. 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?
The study was stopped early (reason given: Mobile-bearing insert dislocation). Results are not available in the source record.
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 on the first 20 patients (fluoroscopy subset) (time frame: First or second day postoperatively, 6 months, 1 year). 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 7 Mar 2018.