Artificial Knee Joint for Knee Replacement

Recruiting at 8 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

145 Participants Needed

Trial Summary

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 Tritanium Cone Augments for knee replacement?

Research shows that 3D-printed cone augments, similar to Triathlon Tritanium Cone Augments, can significantly improve knee function and delay the need for more extensive surgeries in patients with bone defects. In a study, patients experienced improved knee scores and range of motion after using these cones in knee replacement revisions. ^{1 2 3 4 5}

Is the artificial knee joint for knee replacement generally safe for humans?

The studies suggest that tritanium cones, used in knee replacement surgeries, are generally safe with few specific complications noted. Infections occurred in a small percentage of patients, but overall, the use of these cones showed good clinical and radiological outcomes. ^{1 2 3 4 6}

What makes the Triathlon Tritanium Cone Augments treatment unique for knee replacement?

The Triathlon Tritanium Cone Augments treatment is unique because it uses a cementless design with advanced 3D printing technology, which allows for strong biological fixation to the bone, potentially leading to better long-term outcomes compared to traditional cemented knee replacements. ^{1 7 8 9 10}

What is the purpose of this trial?

This trial is testing a knee replacement system that includes special cone-shaped parts made from Tritanium. It is aimed at patients who need a second knee replacement surgery because their first one failed. The cone-shaped parts are designed to fit into the bone and keep the new knee implant securely in place, reducing the chance of it becoming loose. Tritanium cones are used to manage bone loss in revision total knee arthroplasty, providing stability and support for the new implant.

Eligibility Criteria

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

I have a condition like Lupus or Paget's disease that worsens my bone health.

Timeline

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

Treatment Details

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.

Participant Groups

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

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A finite element analysis of tibial tritanium cones without stems in varying bone defects. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Metaphyseal cones in revision total knee arthroplasty: The role of stems. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

A prospective study on outcome of patient-specific cones in revision knee arthroplasty. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Does the use of 3D-printed cones give a chance to postpone the use of megaprostheses in patients with large bone defects in the knee joint? [2022]

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

Do Porous Tantalum Metaphyseal Cones Improve Outcomes in Revision Total Knee Arthroplasty? [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Comparative Analysis between Cone and Sleeve in Managing Severe Bone Defect during Revision Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. [2019]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

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

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

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