What side effects are associated with this type of intervention?

Common treatments for joint replacement surgery, such as the use of structural supports like the Triathlon Tritanium Cone Augments, aim to enhance stability and prevent aseptic loosening. Known side effects of these treatments can include infection, blood clots, implant loosening or failure, and adverse reactions to the materials used in the implants. Additionally, patients may experience pain, swelling, and limited mobility during the recovery period. It is important for patients to discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved various treatments for joint replacement surgery aimed at providing structural support and stability to prevent aseptic loosening. One such treatment is the Triathlon Tritanium Cone Augments, which are used in revision total knee arthroplasty to enhance stability and reduce the risk of aseptic loosening. These cone augments are designed to provide a stable foundation for the implant, thereby improving the longevity and success of the joint replacement. Other related FDA-approved treatments include different types of bone grafts, cementless fixation devices, and specialized coatings for implants that promote bone growth and integration.

What other types of research exist?

Promising novel alternatives to Triathlon Tritanium Cone Augments for joint replacement surgery include: 1) Conical hybrid connections, which have shown better screw stability compared to internal hex connections. 2) Pyrocarbon implants, which offer theoretical advantages and have shown good short-term outcomes, though long-term data is still required. 3) The STAR ankle replacement prosthesis, which has shown encouraging results in FDA studies and promises improved outcomes with further research.

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Orthopedic Implant

Artificial Knee Joint for Knee Replacement

N/A

Waitlist Available

Research Sponsored by Stryker Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation

Patient is a candidate for revision of all femoral and tibial components of a total knee replacement

Must not have

Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration

Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks of knee revision surgery may include pain at the site, infection risk increase and possible complications related to implant loosening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am eligible for a complete knee replacement revision.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am on long-term steroids or have a weakened immune system.

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I might have an infection in or near my knee where a device will be implanted.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Anderson Orthopaedic Research Institute (AORI) classification and Femoral Cone Augment size.

Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.

Bone structure of tibia

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Triathlon Tritanium Cone AugmentsExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

In joint replacement surgery, particularly with treatments like the Triathlon Tritanium Cone Augments, the primary mechanism of action involves providing structural support and stability to prevent aseptic loosening. Cone augments fill bone defects and create a stable foundation for the implant, which enhances the overall stability of the joint replacement. This is crucial for patients as it reduces the risk of implant failure, minimizes the need for revision surgeries, and improves long-term outcomes and quality of life.

Early versus late weight bearing & ankle mobilization in the postoperative management of ankle fractures: A systematic review and meta-analysis of randomized controlled trials.Comparison of Outcomes by Reconstructive Strategy in Patients with Prostheses for Proximal Femoral Focal Deficiency.Prognosis research ideally should measure time-varying predictors at their intended moment of use.