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MDR - G7 中性和 G7 自由约束中性髋臼内衬

2026年9月29日 更新者:Zimmer Biomet

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

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:Erin Osborn、Zimmer Biomet

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年4月1日

初级完成 (实际的)

2022年6月30日

研究完成 (实际的)

2022年6月30日

研究注册日期

首次提交

2019年7月18日

首先提交符合 QC 标准的

2019年9月17日

首次发布 (实际的)

2019年9月18日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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