Triathlon PSR Outcomes Study

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

37 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial evaluates a knee replacement system called the Triathlon Total Knee System with a special part known as the PSR Tibial Insert. It targets patients who are having their first knee replacement surgery. The system works by replacing damaged knee parts with artificial ones to help improve movement and reduce pain. The Triathlon Total Knee System has shown excellent early outcomes and high survival rates in previous studies.

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 data supports the effectiveness of the treatment Triathlon PSR Tibial Insert?

Research on the Triathlon Total Knee system, which includes the PSR Tibial Insert, shows excellent outcomes and high patient satisfaction up to 10 years after surgery, with a 95.4% survivorship rate. Studies also highlight significant improvements in knee function and pain relief shortly after surgery, which are maintained over time. ^{1 2 3 4 5}

Is the Triathlon PSR Tibial Insert safe for use in humans?

The Triathlon knee replacement system, which includes the PSR Tibial Insert, has been used in many knee surgeries and generally shows good safety with high patient satisfaction and low complication rates over 10 years. However, there are rare cases of complications, such as dislocation of the insert in infected joints. ^{1 2 6 7 8}

How does the Triathlon PSR Tibial Insert treatment differ from other treatments for knee conditions?

The Triathlon PSR Tibial Insert is part of a cementless total knee arthroplasty system, which offers potential benefits like improved biological fixation compared to traditional cemented systems. This approach may lead to better long-term outcomes and reduced revision rates due to advances in implant design and materials. ^{1 6 7 9 10}

Eligibility Criteria

Inclusion Criteria

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

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

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

Treatment Details

Interventions

• Triathlon PSR Tibial Insert

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes and survivorship of cementless triathlon total knee arthroplasties: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ten-Year Results of the Triathlon Knee Replacement: A Cohort Study. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Clinical and radiographic short mid-term outcomes of primary total stabilizer knee arthroplasty. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Comparative Analysis of Contemporary Fixed Tibial Inserts: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Early experience with a new total knee implant: maximizing range of motion and function with gender-specific sizing. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Dislocation of a polyethylene insert in an infected knee joint after a Triathlon total knee arthroplasty. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Five-year survivorship and patient-reported outcome of the Triathlon single-radius total knee arthroplasty. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Excellent 10-year patient-reported outcomes and survival in a single-radius, cruciate-retaining total knee arthroplasty. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Excellent mid-term follow-up for a new 3D-printed cementless total knee arthroplasty. [2021]