MDR - G7 中性和 G7 自由约束中性髋臼内衬
G7 Freedom Constrained Neutral Liner 和 G7 Neutral +5mm Liner 在初次和翻修全髋关节置换术(植入物和器械)中的上市后临床随访研究
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
研究概览
详细说明
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).
研究类型
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
This will include a consecutive series of subjects implanted with the G7 Freedom Constrained Liners in primary and revision total hip arthroplasty according to the approved
描述
Inclusion Criteria:
- Patient must be 18 years of age or older and skeletally mature
- Patient must be willing and able to sign Institution Review Board (IRB) approved informed consent
- Noninflammatory degenerative joint disease including:
- Osteoarthritis
- Avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other -techniques
- High risk of dislocation due to:
- History of prior dislocation
- Bone loss
- Joint or soft tissue laxity
- Neuromuscular disease
- Intraoperative instability
- Revision procedures where other treatment or devices have failed
Exclusion Criteria:
- Off-label use
- Infection and/or distant foci of infections which may spread to the implant site
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease
- 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
- Patient is unwilling to sign an informed consent
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
G7 Freedom Constrained Liners
Patients that have been implanted with a G7 Freedom Constrained liner to repair hip malfunction or disease. |
Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Device Safety assessed through the frequency and incidence of revisions, complications and adverse events
大体时间:Out to five years
|
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified. |
Out to five years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Device Performance and Benefits evaluated through the Oxford Hip Score
大体时间:Out to five years
|
The OHS is a patient completed 12 question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms. |
Out to five years
|
合作者和调查者
调查人员
- 研究主任:Erin Osborn、Zimmer Biomet
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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