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2014年3月31日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Stryker European Operations BV (Netherlands)
- 入组人数
- 100
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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