Artificial Knee Joint for Knee Replacement

Not currently recruiting at 9 trial locations

Overseen By Filesha Haniff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: BMI > 45, Infection, Neuromuscular deficiency, Systemic disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special knee implant called the Triathlon Tritanium Cone Augments for individuals needing a second knee replacement surgery. The goal is to determine if this implant can reduce the risk of the knee joint loosening over time. Suitable candidates have already undergone a knee replacement but require another surgery to replace both the upper and lower parts of the knee joint. This trial does not suit individuals with certain conditions, such as severe bone diseases or infections around the knee. As an unphased trial, it provides a unique opportunity to contribute to 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 Tritanium Cone Augments are safe for knee replacement?

Research shows that Triathlon Tritanium Cone Augments are safe for knee surgeries. Studies have found that patients usually tolerate these cone augments well. The likelihood of the parts becoming loose within two years is less than 2.8%. Most patients do not encounter major issues after surgery with these cone augments. This treatment is used in revision knee surgery, a follow-up procedure to fix or replace parts of a knee implant. Side effects are generally mild and similar to those of other knee surgeries. For concerns, discussing how this treatment might work with a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Triathlon Tritanium Cone Augments are unique because they incorporate advanced materials designed to enhance bone integration and stability in knee replacements. Unlike traditional knee replacement options that use standard metal components, these cone augments are made from porous titanium, which can encourage natural bone growth and potentially lead to a more secure and long-lasting joint. Researchers are excited about this treatment because it offers a promising solution for patients with compromised bone structure, aiming to improve outcomes and reduce the likelihood of revision surgeries.

What evidence suggests that the Triathlon Tritanium Cone Augments are effective for knee replacement?

Research has shown that the Triathlon Tritanium Cone Augments, which participants in this trial will receive, are highly effective for knee replacements. One study found that the chance of needing another surgery due to parts coming loose without infection is less than 2.8%, indicating that the parts remain securely attached. Additionally, the Stryker Triathlon Total Knee System, which includes these cone augments, has demonstrated a high success rate, with 98.7% of knee replacements lasting well overall and 99.2% lasting well without issues related to loosening. These findings suggest that these augments are a reliable choice for knee surgeries, making them a promising option for those needing a knee replacement. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 needing revision knee replacement surgery, who can follow the post-op plan. It's not for those with a BMI over 45, infections around the knee, systemic diseases like Lupus, excessive steroid use, prisoners, material allergies or certain neuromuscular issues.

Inclusion Criteria

Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form

I am over 18, not pregnant, and my bones have stopped growing.

I am eligible for a complete knee replacement revision.

Exclusion Criteria

Patient is a prisoner

Patient has a known sensitivity to device materials

Patient has a failed unicondylar knee prosthesis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision total knee arthroplasty (TKA) with the Triathlon TS Total Knee System and Triathlon Tritanium Cone Augments

Intraoperative

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of end-of-stem pain and AORI classification

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Triathlon Tritanium Cone Augments

Trial Overview The study evaluates Triathlon Tritanium Cone Augments in knee revision surgeries. It aims to show that less than 2.8% of these augments will loosen within two years after surgery without randomizing patients into different treatment groups.

How Is the Trial Designed?

Group I: Triathlon Tritanium Cone Augments Experimental Treatment 1 Intervention

Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02521103

Triathlon Tritanium Cone Augments Outcomes Study The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/03/NCT02521103/Prot_SAP_000.pdf

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

3. ctv.veeva.com ctv.veeva.com/study/triathlon-tritanium-cone-augments-outcomes-study

Triathlon Tritanium Cone Augments Outcomes Study The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the ...

4. withpower.com withpower.com/trial/phase-7-2015-0bebe

Artificial Knee Joint for Knee Replacement 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 ...

5. stryker.com stryker.com/content/dam/stryker/joint-replacement/training-and-education/2023-jr-fellows-summit/resources/TRITS-PG-6_Rev-1_21969.pdf

Triathlon® Tritanium® Cone Augments Treatment of large bone defects with trabecular metal cones in revision total knee arthroplasty: short term clinical and radiographic outcomes. J. Arthroplasty ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/K143393.pdf

Stryker Orthopaedics Ms. Margaret Klippel Associate Strategic ... The Triathlon® Tritanium® Cone Augment is intended for use in primary or revision total knee arthroplasty where there is a femoral and/or tibial ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02521103?term=tritanium&viewType=Table&rank=5

Triathlon Tritanium Cone Augments Outcomes Study Patient has a Body Mass Index (BMI) > 45. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device ...