Migration and survival of all-polyethylene tibial components compared to the metal-backed modular components of the Triathlon CS Total Knee System. A RSA study

Stryker European Operations BV (Netherlands)0 个研究点目标入组 60 人开始时间: 2014年9月22日最近更新: 2023年12月19日

适应症

试验速览

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35099566/ (added 05/12/2023) 2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29714073/ 2-year results (added 05/12/2023)

•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. Patients eligible and scheduled to undergo primary total knee replacement with any of the following indication
•2.1. Painful and disabled knee joint resulting from osteoarthritis (Ahlbäck stage II to V)
•2.2. 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 subject is a male or non-pregnant female between 40 and 75 years of age

•1. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 37
•2. Previous major knee surgery
•3. Patients who had a Total Knee Arthroplasty (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. Patients with other severe concurrent joint involvements that can affect their outcome
•5. Patient has a flexion contracture of 15° and more
•6. Patient has a varus/valgus contracture of 15° and more
•7. The subject will be operated bilaterally
•8. The subject has an active or suspected latent infection in or about the knee joint
•9. Osteomyelitis
•10. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
•11. The subject has a systemic or metabolic disorder leading to progressive bone deterioration
•12. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements
•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

发起方

Stryker European Operations BV (Netherlands)