Global, Multicenter and Prospective Post-Market Clinical Follow-Up Study of the G7® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 358
- 试验地点
- 20
- 主要终点
- Survival of the implant system
研究概览
简要总结
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty
详细描述
The G7 Dual Mobility construct offers dislocation resistance without the need to constrain the femoral head, providing stability and high range of motion. Dual Mobility systems decrease the risk of post-operative instability in high-risk patients in both primary and revision arthroplasties.
This study will enroll up to 358 hips globally, 179 for the Vivacit-E and 179 for the Longevity polyethylene bearings. From the 179 hips per bearing variant, the study will enroll 60 primary and 119 revision arthroplasty hips. The Longevity bearing variant will only be enrolled in the US, as it is not CE marked and unregistered in the APAC market. Vivacit-E bearings will be enrolled globally.
A maximum of 20 study centers will be selected globally. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target maximum 24 primary hip arthroplasties and maximum 47 revision hip arthroplasties. Each site is encouraged to enroll both, primary and revision, subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 to 80 years of age, inclusive
- •Patient is skeletally mature
- •Patient qualifies for (total) hip arthroplasty based on physical exam and medical history including at least one of the following:
- •Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- •Rheumatoid arthritis
- •Dislocation risks
- •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 is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
- •Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent
排除标准
- •Patient is septic, has an active infection or has osteomyelitis at the affected joint
- •Patient has significant osteoporosis as defined by treating surgeon
- •Patient has metabolic disorder(s) which may impair bone formation
- •Patient has osteomalacia
- •Patient has distant foci of infections which may spread to the implant site
- •Patient has rapid joint destruction, marked bone loss or bone resorption apparent on pre-operative radiographs
- •Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
- •Patient is undergoing simultaneous bilateral THA
- •Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which are likely to jeopardize the outcome of the surgery.
- •Patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- •Patient is known to be pregnant
- •The patient is in a vulnerable population group such as:
- •a prisoner
- •a known alcohol or drug abuser
- •mentally incompetent or unable to understand what participation in this study entails
结局指标
主要结局
Survival of the implant system
时间窗: 10 years
Survival of the implant system based on removal of the study device
Safety of the implant system
时间窗: 10 years
Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
次要结局
- Radiographic Assessment(5 years)
- EQ-5D-5L(10 years)
- Oxford Hip Score(10 years)
- Modified Harris Hip Score(10 years)