Triathlon Tritanium Cone Augments Outcomes Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2028-03-31

Brief Summary

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This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. 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 Augments at 2 years postoperative.

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Detailed Description

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Conditions

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Arthroplasty Replacement Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triathlon Tritanium Cone Augments

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

Group Type OTHER

Triathlon Tritanium Cone Augments

Intervention Type DEVICE

The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in primary or revision TKA

Interventions

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Triathlon Tritanium Cone Augments

The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in primary or revision TKA

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
* 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.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

* 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 implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* 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).
* Patient has a failed unicondylar knee prosthesis.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No