Triathlon Tritanium Tibia Registry: National Multicentre Surveillance Register

Stryker0 个研究点目标入组 350 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•1. Patient is able to understand the meaning of the study and is willing to sign the EC approved, study specific Informed Patient Consent Form.
•2. Patient eligible and scheduled to undergo primary total knee replacement with any of the following indications:
•- Painful and disabled knee joint resulting from osteoarthritis (Ahlbäck stage II-V)
•- One or more compartments are involved
•3. Ability and willingness to follow instructions, including control of weight and activity level and to return for follow-up evaluations.
•4. A good nutritional state of the patient.
•5. The patient is a male or non-pregnant female between 40 and 75 years of age.

•1. The patient is morbidly obese, defined as Body Mass Index (BMI) of > 37.
•2. Previous major knee surgery.
•3. Patient who had a TKA on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 3 months ago with good outcome can be included in the study).
•4. Patient with other severe concurrent joint involvements that can affect their outcome.
•5. Patient has a flexion contracture of 15 degrees.
•6. Patient has a varus/valgus contracture of 15 degrees and more.
•7. The patient will be operated bilaterally.
•8. The patient has an active or suspected latent infection in or about the knee joint.
•9. Osteomyelitis.
•10. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
•11. The patient has a systemic or a metabolic disorder leading to progressive bone deteri-oration.
•12. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
•13. Female patients planning a pregnancy during the course of the study.
•14. The patient is unable or unwilling to sign the Informed Consent specific to this study.

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