Total Knee ArthroplastyTriathlonCRNCT02535741
Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee
A study testing Triathlon CR Total Knee System in people with Total Knee Arthroplasty, run by Stryker Orthopaedics at 6 sites in 4 countries.
Trial summary
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Triathlon CR Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Oct 2006to May 2016
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
- Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery.
- Patients requiring a primary total knee replacement.
- Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Patients with intact collateral ligaments.
Who cannot join
- Patients with inflammatory arthritis.
- Patients that are morbidly obese, body mass index (BMI) > 40.
- Patients with a history of total / unicompartmental reconstruction of the affected joint.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
Show all 12Show fewer
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days duration).
- Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- Patients with a knee fusion to the affected joint.
- Patients with an active or suspected latent infection in or about the knee joint.
- Patients with a history of total joint replacement on the opposite knee within less than 1 year.
- Patients requiring bilateral total knee replacement.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany2 sites
DRK Klinik Baden-Baden
Baden-Baden, Baden-Wurttemberg, 76530
Medizinische Universität Hannover
Hanover, Lower Saxony, 30625
Spain2 sites
Instituto Municipal de Asistencia Sanitaria
Barcelona, CP08003
Hospital Costa del Sol
Marbella, Andalusia, 24156005 W
Finland1 site
Hospital District of South West Finland
Turku, Westfinland, 20521
About this study
Official title: Clinical Outcome Study for the Triathlon CR Total Knee
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.
Read the detailed description
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Triathlon CR Total Knee System
- Keywords
- Knee Replacement, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon CR Total Knee SystemDevice
Primary total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| Triathlon CR Total Knee System | Other | Primary total knee replacement Receives: Device: Triathlon CR Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Triathlon CR Active Range of Motion (ROM)
Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.
Measured: 2 years follow-up
Secondary outcomes (4)
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 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, 3 months, 1, 2, 3, 4 and 5 years follow-up
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire
The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Measured: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire
The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.
Measured: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startOct 2006
- Primary completionMay 2013
- Study completionMay 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Stukenborg-Colsman, Prof., Principal investigator, Medizinische Universität Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535741
- Sponsor's protocol ID
- K-S-016
- Acronym
- TriathlonCR
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2015
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.
PubMed 19047702
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
- Clinical Outcome Study for the Triathlon CR Total Knee
- ClinicalTrials.gov ID
- NCT02535741
- Acronym / sponsor ID
- TriathlonCR / K-S-016
- Conditions
- Total Knee Arthroplasty
- Keywords
- Knee Replacement, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- May 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 7 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.
Detailed description
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triathlon CR Total Knee System | Other | Device: Triathlon CR Total Knee SystemPrimary total knee replacement |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation.
- Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery.
- Patients requiring a primary total knee replacement.
- Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
Key exclusion criteria (12 listed)
- Patients with inflammatory arthritis.
- Patients that are morbidly obese, body mass index (BMI) > 40.
- Patients with a history of total / unicompartmental reconstruction of the affected joint.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
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 CR Total Knee SystemPrimary total knee replacement | Device | Triathlon CR Total Knee System |
Primary outcome
Mean Triathlon CR Active Range of Motion (ROM)
Time frame: 2 years follow-up
Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.
4 secondary outcomes
Investigation of Patient Outcome With Radiographic Analysis
Time frame: Pre-operative, 3 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, 3 months, 1, 2, 3, 4 and 5 years follow-up
Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire
Time frame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire
Time frame: Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up
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.
- Background: PubMed 19047702Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.
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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.
Christina Stukenborg-Colsman, Prof. principal investigator
Medizinische Universität Hannover
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triathlon CR Total Knee System in people with Total Knee Arthroplasty, run by Stryker Orthopaedics at 6 sites in 4 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 6 inclusion and 12 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 6 sites in Germany, Spain, Denmark, Finland. 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 Dec 2015). 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?
Mean Triathlon CR Active Range of Motion (ROM) (time frame: 2 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535741, which also lists 1 linked publication.
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.