ISRCTN10744502进行中（未招募）3 期
Migration and survival of all-polyethylene tibial components compared to the metal-backed modular components of the Triathlon PS 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11月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31550947/ 2-year results (added 05/12/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35099566/ 5-year results (added 05/12/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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 with a pre-operative knee score of < 70
- •3. Patients scheduled to undergo primary total knee replacement with any of the following indication
- •3.1. Painful and disabled knee joint resulting from osteoarthritis
- •3.2. One or more compartments are involved
- •4. No indication for Triathlon PS
- •5. Need to obtain pain relief and improve function
- •6. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
- •7. A good nutritional state of the patient
- •8. The subject is a male or non-pregnant female between 40 and 75 years of age
排除标准
- •1. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40
- •2. Patient has a flexion contracture of 15° and more
- •3. Patient has a varus/valgus contracture of 15° and more
- •4. Patients with a pre-operative knee score of >70
- •5. The subject has a history of total or unicompartmental reconstruction of the affected joint
- •6. The subject will be operated bilaterally
- •7. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study)
- •8. 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 > 6 months ago with good outcome can be included in the study)
- •9. The subject has an active or suspected latent infection in or about the knee joint
- •10. Osteomyelitis
- •11. Sepsis
- •12. Patient who is expected to need lower limb joint replacement for another joint within one year
- •13. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
- •14. The subject has a systemic or metabolic disorder leading to progressive bone deterioration
- •15. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements
- •16. The subject?s bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis
- •17. The subject has had a knee fusion to the affected joint
- •18. Female patients planning a pregnancy during the course of the study
- •19. The patient is unable or unwilling to sign the Informed Consent specific to this study
研究者
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