NL-OMON52880招募中不适用
Triathlon Tritanium Tibia Registery; national multicentre surveillance register - Triathlon Tritanium Tibia Registery
Reinier Haga Orthopedisch Centrum0 个研究点目标入组 350 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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. 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
- •- 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.
排除标准
- •1. The patient is morbidly obese, defined as Body Mass Index (BMI) of > 37.
- •2. Previous major knee surgery.
- •3. Patient 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. 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
- •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 deterioration.
- •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.
研究者
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