Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Adverse Event (safety)
研究概览
简要总结
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.
详细描述
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified.
The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must be a legal adult who has reached full skeletal maturity.
- •Patient must be treated for one of the following indications:
- •Noninflammatory degenerative joint disease including osteoarthritis and 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
- •Revision procedures where other treatment or devices have failed
- •Patient must be able and willing to complete the protocol required follow-up visits.
- •Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent.
排除标准
- •Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.
- •Patient has a metabolic disorder that may impair bone formation.
- •Patient has osteomalacia.
- •Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.
- •Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
- •Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease
- •Patient is a prisoner.
- •Patient is a current alcohol or drug abuser.
- •Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- •Patient is pregnant.
研究组 & 干预措施
G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners
Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up.
干预措施: Vivacit-E and Longevity (HXLPE) Liners (Device)
结局指标
主要结局
Adverse Event (safety)
时间窗: At 10 years
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Survival of the study device (liner); whether or not it is still implanted in the subject
时间窗: At 10 years
Survivorship will be based on revision or intended revision of the study device (liner).
次要结局
- Pain and Function using Modified Harris Hip Score(At 10 years)
- Patient Quality of Life using EQ-5D-5L Descriptive System(At 10 years)
- Pain and Function using Oxford Hip Score(At 10 years)
- Patient Quality of Life using EQ-5D-5L EQ visual analogue scale(At 10 years)