Triathlon Tritanium Cone Augments Outcomes Study

  • STATUS
    Recruiting
  • End date
    Jul 25, 2028
  • participants needed
    145
  • sponsor
    Stryker Orthopaedics
Updated on 25 March 2022

Summary

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.

Details
Condition Arthroplasty, Replacement, Knee
Treatment Triathlon Tritanium Cone Augments
Clinical Study IdentifierNCT02521103
SponsorStryker Orthopaedics
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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