ISRCTN12965327已完成未知
Polyethylene wear study on the triathlon total knee prosthesis: a prospective randomized single centre study
Stryker European Operations BV (Netherlands)0 个研究点目标入组 100 人开始时间: 2014年3月31日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- 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. Need to obtain pain relief and improve function.
- •5. Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
- •6. A good nutritional state of the patient.
- •7. Full skeletal maturity of the patient, patients who are at least 18 years of age.
- •8. Patients of either sex.
排除标准
- •1. The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40.
- •2. Skeletal immaturity of the patient, patients who are less than 18 years of age.
- •3. Patient has a flexion contracture of 15° and more.
- •4. Patient has a varus/valgus contracture of 15° and more.
- •5. Patients with a pre-operative knee score of >70.
- •6. The subject has a history of total or unicompartmental reconstruction of the affected joint.
- •7. The subject will be operated bilaterally.
- •8. 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).
- •9. 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).
- •10. The subject has an active or suspected latent infection in or about the knee joint
- •11. Osteomyelitis
- •12. Sepsis
- •13. Patients who will need lower limb joint replacement for another joint within one year.
- •14. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •15. The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- •16. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- •17. The subject?s bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- •18. The subject has had a knee fusion to the affected joint.
- •19. Female patients planning a pregnancy during the course of the study.
- •20. The patient is unable or unwilling to sign the Informed Consent specific to this study.
研究者
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