Ypsilanti, Michigan 48197

  • Knee

Purpose:

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.


Criteria:

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.


NCT ID:

NCT02521103


Primary Contact:

Ajay Rastogi
Phone: 201-831-5807
Email: ajay.rastogi@stryker.com


Backup Contact:

Email: jillian.mohn@stryker.com
Jillian Mohn
Phone: 201-831-5496


Location Contact:

Ypsilanti, Michigan 48197
United States

Kara Sawaya
Phone: 734-712-8087
Email: ksawaya@michiganheart.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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