Triathlon PSR Tibial Insert for Knee Replacement

Overseen By Britta von den Brincken

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: BMI > 45, Avascular necrosis, Inflammatory arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate post-operative care

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee insert called the Triathlon PSR Tibial Insert, designed to improve outcomes for people undergoing total knee replacement surgery. The researchers aim to determine if this new insert performs as well as older versions, helping patients regain mobility and reduce pain. It suits those with non-inflammatory degenerative joint disease, such as osteoarthritis, who are planning their first knee replacement surgery. Participants must adhere to a follow-up routine after surgery to track their progress. As an unphased trial, this study offers patients the opportunity to contribute to valuable research that could enhance future knee replacement outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking steroids in excess of normal physiological requirements, you may not be eligible to participate.

What prior data suggests that the Triathlon PSR Tibial Insert is safe for primary total knee arthroplasty?

Research has shown that the Triathlon PSR Tibial Insert, used in knee replacement surgeries, is generally safe for patients. Studies have found that patients tolerate this device well, with few problems. Available data reports no serious side effects or major complications.

Testing has confirmed the device's effectiveness and safety, and it is approved for use in knee surgeries, meeting safety standards for medical devices. The design of the Triathlon PSR Tibial Insert aims to allow more natural knee movement, reducing discomfort.

Overall, safety data supports the Triathlon PSR Tibial Insert as a reliable option for those undergoing knee replacement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Triathlon PSR Tibial Insert is unique because it offers a more personalized approach to knee replacement. Unlike standard tibial inserts, which often come in a fixed shape and size, the Triathlon PSR Tibial Insert is designed to fit more precisely with a patient's knee anatomy. This could potentially lead to better joint stability and a more natural range of motion. Researchers are excited about this treatment because it may improve patient outcomes by reducing wear and tear on the joint and enhancing overall comfort and mobility after surgery.

What evidence suggests that the Triathlon PSR Tibial Insert is effective for total knee arthroplasty?

Research has shown that the Triathlon Total Knee System, including the Triathlon PSR Tibial Insert under study in this trial, performs well over time. One study found that 95.4% of these knee replacements functioned properly 10 years after surgery, indicating successful outcomes for most patients a decade later. Another study reported that patients with the Triathlon knee replacement experienced significant pain relief and improved knee function. These findings suggest that the Triathlon PSR Tibial Insert effectively enhances knee replacement outcomes. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form

Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

You need a knee replacement surgery and it will be done using cement.

Exclusion Criteria

Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation

Patient has a Body Mass Index (BMI) > 45

Patient is already participating in the study for a contralateral total knee replacement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments including EQ-5D and SF-36 questionnaires

1 week

1 visit (in-person)

Treatment

Participants receive the Triathlon Total Knee System with the Triathlon PSR Tibial Insert

Surgery and immediate post-operative care

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments at 6 weeks and 1 year

1 year

2 visits (in-person)

Long-term Follow-up

Survivorship of the Triathlon PSR Insert is evaluated over a 10-year period

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Triathlon PSR Tibial Insert

How Is the Trial Designed?

Group I: Triathlon PSR Tibial Insert Experimental Treatment 1 Intervention

Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert

Who Is Running the Clinical Trial?

Stryker Orthopaedics

Lead Sponsor

Trials

79

Recruited

20,500+

Kevin A. Lobo

Stryker Orthopaedics

Chief Executive Officer since 2012

Bachelor's degree in Commerce from McGill University, MBA from University of Toronto

Dr. Jorge Enrique Diaz

Stryker Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan Medical School

Published Research Related to This Trial

The Stryker Triathlon Total Knee System shows excellent survivorship rates of 98.7% overall and 99.2% for aseptic causes, based on a systematic review of 20 studies with a mean follow-up of 3.8 years.

Clinical outcomes are also promising, with average Knee Society Scores (KSS) indicating high levels of pain relief (92.2) and functional improvement (82.7), suggesting effective performance of the cementless implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and survivorship of cementless triathlon total knee arthroplasties: a systematic review. Carlson, BJ., Gerry, AS., Hassebrock, JD., et al.[2022]

The Triathlon total knee replacement (TKR) showed excellent outcomes, with a 95.4% survivorship rate at 10 years post-surgery, indicating its long-term reliability for patients.

Patients experienced significant improvements in pain and function within the first three months after surgery, with satisfaction rates ranging from 79% to 94% over the follow-up period, demonstrating the effectiveness of the Triathlon prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-Year Results of the Triathlon Knee Replacement: A Cohort Study. Wylde, V., Penfold, C., Rose, A., et al.[2021]

In a study involving 60 patients, both the posterior stabilised and cruciate retaining versions of the Triathlon™ total knee prosthesis showed similar early stability in terms of tibial component migration over a two-year follow-up period.

Despite differences in specific types of movement (translation) between the two prosthesis types, there were no significant differences in clinical outcomes or functional performance, indicating both designs are effective options for knee arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial. Molt, M., Toksvig-Larsen, S.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04618770

NCT04618770 | Triathlon PSR Outcomes Study This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04618770?term=AREA%5BBasicSearch%5D(triathlon%20knee)&rank=7

NCT04618770 | Triathlon PSR Outcomes Study This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon ...

3. withpower.com withpower.com/trial/phase-1-2021-b8af0

Triathlon PSR Outcomes Study · Info for Participants The Triathlon total knee replacement (TKR) showed excellent outcomes, with a 95.4% survivorship rate at 10 years post-surgery, indicating its long-term ...

4. smartpatients.com smartpatients.com/trials/NCT04618770

Triathlon PSR Outcomes Study This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5137655/

Comparison of patient reported outcomes after Triathlon® and ... This study found that patients who had the Triathlon® prosthesis had significantly better pain relief (p<0.0001), function (p=0.028), knee related quality of ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K203421.pdf

K203421.pdf - accessdata.fda.gov Rotation (PSR) Triathlon@ tibial inserts. Type of Use (Select one or ... Safety and Effectiveness Data. The assessment of the non ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/70/NCT04618770/Prot_SAP_000.pdf

Triathlon PSR Outcomes Study Triathlon Total Knee System using the Triathlon PSR Tibial Insert. Sponsor ... documents, regulatory documents, data collection instruments, study data).

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K190402.pdf

August 22, 2019 Stryker Orthopaedics Margaret Crowe Klippel ... The Triathlon® All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (PS) and ...

9. stryker.com stryker.com/content/dam/stryker/no-index/training-and-education/jr45/june/resources/Triathlon%20Knee%20Replacement%20Presentation.pdf

Triathlon® TS Tibial Insert provides +/- 2˚ valgus-varus constraint but permits +/- 7˚ rotational freedom. • In a study of 172 difficult primary TKAs with two-year follow- ...