NCT03450733已完成不适用
Post-Market Surveillance of the Wright Medical Technology Metal-on-Metal Total Hip System (FDA 522 Order)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 4
- 主要终点
- Rate of Adverse Local Tissue Reactions (ALTR)
研究概览
简要总结
This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of ≤ 8 years and > 8 years, since implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in Group 1, subjects must meet all of the following criteria:
- •Has been implanted with appropriate components of the WMT MOM THA System
- •Has previously undergone primary THA for any of the following:
- •non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- •inflammatory degenerative joint disease including rheumatoid arthritis;
- •correction of functional deformity.
- •Is willing and able to complete required study visit(s) and assessments
- •Plans to be available for the required study visit
- •Is capable of providing sufficient blood for sampling according to blood draw procedures
- •Is willing to sign the approved Informed Consent document
- •Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement and protocol enrollment strategy, and 4) the subject agrees to a second Informed Consent document and data collection specific to the second THA. Enrollment and treatment of a previously unimplanted hip is not permitted in this study.
- •To be included in Group 2, subjects must meet all of the following criteria:
- •Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants
- •Is not an employee of the Investigator
- •Is willing and able to provide Informed Consent document
- •Is willing and able to attend the requested study visit(s) and assessments
- •Is capable of providing sufficient blood for sampling according to blood draw procedures
排除标准
- •Subjects will be excluded from either study group if they meet any of the following criteria:
- •Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- •Subject is unwilling or unable to sign the Informed Consent document
- •Subject has documented substance abuse issues
- •Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- •Subject is currently incarcerated or has impending incarceration
- •Group 1 only: Subject has a condition or previously implanted medical device that contraindicates MRI (e.g. pacemaker, implantable defibrillator)
- •Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of implantation
结局指标
主要结局
Rate of Adverse Local Tissue Reactions (ALTR)
时间窗: ≤ 8 years and > 8 years, since implantation
To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)
次要结局
- Determine chromium and cobalt whole blood and serum ion levels across time intervals(≤ 8 years and > 8 years, since implantation)
- Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals(≤ 8 years and > 8 years, since implantation)
- Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).(≤ 8 years and > 8 years, since implantation)
- Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).(≤ 8 years and > 8 years, since implantation)
研究者
研究点 (4)
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