NCT04064008Enrolling By Invitation不适用
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Survivorship of ProFemur Z Stem out to 10 years
研究概览
简要总结
Single center, prospective follow-up of previously implanted subjects
详细描述
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
- •Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
- •Subject is willing and able to complete required study visits or assessments.
- •Plans to be available through the 10 year postoperative follow-up visit.
- •Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
- •the PROFEMUR Z Revision Femoral Stem was 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, and
- •the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.
排除标准
- •Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol.
- •Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
- •Has or had an overt infection at the time of implantation.
- •Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation.
- •Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation.
- •Has or had 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.
- •Subjects unwilling to sign the Informed Consent document.
- •Subjects with substance abuse issues.
- •Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- •Subjects who are incarcerated or have pending incarceration.
结局指标
主要结局
Survivorship of ProFemur Z Stem out to 10 years
时间窗: 10 years.
Kaplan-Meier survivorship at specific intervals out to 10 years follow up
次要结局
- to characterize total functional scores for subjects, as assessed by Oxford Hip Scores(2-5 years, 5-7 years, and 10 years.)
- Revision rate of the Profemur Z stem out to 10 years(2-5 years, 5-7 years, and 10 years.)
研究者
研究点 (1)
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