DRKS00007617进行中（未招募）不适用
Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems
MicroPort Scientific Cooperatief U.A.0 个研究点目标入组 64 人开始时间: 2014年12月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Subject previously underwent / is a candidate for primary THA for any of the following:
- •-Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia
- •-Inflammatory degenerative joint disease such as rheumatoid arthritis; or
- •-Correction of functional deformity
- •-Subject has been previously implanted / is a candidate to be implanted with the specified combination of components
- •-Subject is willing and able to complete required study visits or assessments
- •-Not previously implanted subject is able to undergo primary THA procedure
- •Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
- •-the specified combination of components were implanted in both
- •-all other aspects of the Inclusion/Exclusion Criteria are satisfied
- •-enrollment does not exceed the subject count specified in the Clinical Trial Agreement
- •-the subject agrees to a second Informed Consent document specific to the second THA
- •Prospective enrollment of a previously unimplanted contralateral hip is permitted in this study provided:
- •-it occurs not more than two years after the index THA
- •-the specified combination of components is used
- •-all other aspects of the Inclusion/Exclusion Criteria are satisfied
- •-enrollment does not exceed the subject count specified in the Clinical Trial Agreement
- •-the subject agrees to a second Informed Consent document specific to the second THA
排除标准
- •Exclusion Criteria:
- •-Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
- •-Subjects currently enrolled in another clinical study
- •-Subjects unwilling to sign the Informed Consent document
- •-Subjects with substance abuse issues
- •-Subject is incarcerated or has pending incarceration
- •-Subject is anticipated to require a contralateral THA less than 1 year after the index THA on the enrolled hip
- •In addition, not previously implanted subjects will be excluded if they meet any of the following criteria:
- •-Subject has any of the following contraindications at the time of implantation
- •-Overt infection
- •-Distant foci of infections (which may cause hematogenous spread to the implant site)
- •-Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram
- •-Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
- •-Neuropathic joints
- •-Hepatitis or HIV infection
- •-Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
研究者
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