ArthroplastyNCT04618770
Triathlon PSR Outcomes Study
A study testing Triathlon PSR Tibial Insert in people with Arthroplasty and Knee, run by Stryker Orthopaedics at 1 site in United States.
Trial summary
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty, Knee
- What is being tested?
- Triathlon PSR Tibial Insert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 27 Jan 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation.
- Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for primary cemented total knee replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- Patient has a Body Mass Index (BMI) > 45.
- Patient is already participating in the study for a contralateral total knee replacement.
- Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- Patient has a compromised bone stock which cannot provide adequate support to the prosthesis.
Show all 11Show fewer
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- Patient is diagnosed with lumbar radicular pain.
- Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- Patient has a known sensitivity to device materials.
- Patient is a prisoner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.
- Conditions
- Arthroplasty, Knee
- Being tested
- Triathlon PSR Tibial Insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon PSR Tibial InsertDevice
The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
| Study group | Role | What they receive |
|---|---|---|
| Triathlon PSR Tibial Insert | Other | Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert Receives: Device: Triathlon PSR Tibial Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SF-36 Physical Component Score
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; 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, 1 year
Secondary outcomes (3)
EuroQol-5 Dimension (EQ-5D)
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: PreOp, 6 week, 1 year
Range of Motion
Range of Motion evaluates how much the knee can be bent and straightened. The normal range of motion is typically 0 to 135 degrees.
Measured: PreOp, 6 weeks, 1 year
Survivorship of Triathlon PSR Insert
All-cause survivorship of the Triathlon PSR Tibial Insert will be evaluated through 10 year.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start8 Feb 2021
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Why it stopped: Sponsor decision due to lack of enrolment
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 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618770
- Sponsor's protocol ID
- 103
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2020
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert
- ClinicalTrials.gov ID
- NCT04618770
- Acronym / sponsor ID
- 103
- Conditions
- Arthroplasty, Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision due to lack of enrolment
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triathlon PSR Tibial Insert | Other | Device: Triathlon PSR Tibial InsertCases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation.
- Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for primary cemented total knee replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (11 listed)
- Patient has a Body Mass Index (BMI) > 45.
- Patient is already participating in the study for a contralateral total knee replacement.
- Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
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 PSR Tibial InsertThe Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion. | Device | Triathlon PSR Tibial Insert |
Primary outcome
Mean SF-36 Physical Component Score
Time frame: pre-operative, 6 weeks, 1 year
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
3 secondary outcomes
EuroQol-5 Dimension (EQ-5D)
Time frame: PreOp, 6 week, 1 year
Range of Motion
Time frame: PreOp, 6 weeks, 1 year
Survivorship of Triathlon PSR Insert
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 PSR Tibial Insert in people with Arthroplasty and Knee, run by Stryker Orthopaedics at 1 site in United States.
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 11 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 11 Dec 2023. 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 United States. 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 Nov 2023). 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 SF-36 Physical Component Score (time frame: pre-operative, 6 weeks, 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 11 Dec 2023.