Triathlon Total Stabilizer (TS) Outcomes Study

Launched by STRYKER ORTHOPAEDICS · Aug 12, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
• • Patient is a male or non-pregnant female 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) \> 40.
• • 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.