PMCF Study to Provide Safety, Performance, and Clinical Benefits Data of the Longevity IT Oblique and Offset Liners in Primary and Revision Total Hip Arthroplasty - A Retrospective Enrollment/Prospective Follow-up Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent Adverse Events (safety)
研究概览
简要总结
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary or revision total hip arthroplasty (implants and instrumentation) at a minimum of 10-year follow-up.
详细描述
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Longevity IT Oblique and Offset liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 1, 3, 5, 7, and 10 years*. The subject devices have been on the market since 2010 but have insufficient data to support 10 years of clinical history. A prospective aspect to the study will be utilized to collect long-term data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study devices must have been implanted following the appropriate surgical technique and IFU
- •Patient must be 18 years of age or older
- •Patient must be willing and able to sign or verbally consent using the IRB approved informed consent
- •Patient must have undergone primary or revision hip arthroplasty with the Longevity IT Oblique and/or Offset liners according to a cleared indication, which includes the following:
- •Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital, epiphysis, fused hip, fracture of the pelvis, and diastrophic variant
- •Revision where other devices or treatments have failed
- •Patient must have reached full skeletal maturity
排除标准
- •Off-label use of study devices
- •Osteoradionecrosis
- •Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
- •Systemic or local infection
- •Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- •Patient is known to be pregnant or nursing
- •Patient is a prisoner
- •Patient is a known alcohol or drug abuser
- •Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
结局指标
主要结局
Incidence of treatment-emergent Adverse Events (safety)
时间窗: 10 years
This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events with particular focus on those that may be related to the study device.
次要结局
- Performance and Clinical Benefits - Activity Level(10 years)
- Pain and Functional Performance - Oxford Hip Score(10 years)
- Performance and Clinical Benefits - Harris Hip Score(10 years)