CTRI/2019/01/017098招募中4 期
A Prospective, Multicentre, Cohort Study Assessing theSafety and Efficacy of the ANTHEMâ?¢ CR Total KneeSystem in Patients following a Total Knee Arthroplasty
Smith and Nephew Orthopaedics AG0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease.
- •2. Subject is willing to sign and date an EC-approved consent form.
- •3. Subject has posterior cruciate ligament and all collateral ligaments intact in the index joint.
- •4. Subject is 18 to 75 years old at time of inclusion.
- •5. Subject plans to be available through five (5) years postoperative follow-up.
- •6. Subject agrees to follow the study protocol.
- •7. Subject has achieved skeletal maturity as deemed by enrolling investigator.
排除标准
- •1. Subject would receive the ANTHEM• CR Total Knee System on the affected knee as a revision for a previously failed (TKA) or unicondylar knee arthroplasty (UKA).
- •2. Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
- •3. Subject has a history of patellar fracture, patellectomy, or patello-femoral Instability.
- •4. Subject has inflammatory arthritis.
- •5. Subject possesses a contralateral or ipsilateral revision hip arthroplasty.
- •6. Subject has ipsilateral hip arthritis resulting in flexion contracture.
- •7. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
- •- Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty.
- •- Contralateral primary TKA or UKA.
- •8. Inadequate bone stock which would make the procedure unjustifiable including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia as deemed by the enrolling investigator.
- •9. Subject has collateral ligament insufficiency.
- •10. Subject has an active infection or sepsis (treated or untreated) or previous intra-articular infections.
- •11. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated.
- •12. Subject has conditions that may interfere with the TKA survival or outcome (e.g. Pagetâ??s or Charcotâ??s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus [i.e. not under treatment with oral/injectable medications to control blood glucose levels], fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease).
- •13. Subject has contralateral lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
- •14. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- •15. Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse.
- •16. Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
- •17. Any subject that meets the definition of a Vulnerable Subject per ISO14155:2011: individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate.
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