Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Survivorship of the study device
研究概览
简要总结
This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.
详细描述
This multi-center prospective follow-up study will evaluate clinical outcomes, functional outcomes, radiological outcomes and further characterize the safety profile of the G7 Dual Mobility Hip Arthroplasty System. This will be accomplished by assessing these domains using the Harris Hip Score, UCLA Activity Score, and EQ-5D-3L, obtaining and assessing radiographs and the tracking of device or procedure related adverse events. Subjects will undergo unilateral primary or revision total hip arthroplasty and will then be followed for 10 years with intervals at 6 weeks, 1-, 2-, 3- 5- and 10 years. For the 10 year visit, subjects will not be required to present in their doctor's office, but will fill out a survey. Subsequent to 10 year data collection, the subject's participation in the study will be compete.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who are undergoing revision hip arthroplasty
- •Patients who are undergoing total hip arthroplasty (THA) for the correction of a functional deformity
- •Patients in need of treatment of femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- •Patients suffer from substantial pain and/or limited function, are appropriate for a primary total hip arthroplasty, considered at high risk for dislocation and have one of the following:
- •Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- •Rheumatoid arthritis
- •Decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
- •From 18 to 80 years of age (inclusive) at time of procedure
- •BMI equal to or less than 35
- •Unilateral total hip replacement
- •Willing and able to comply with the study procedures
排除标准
- •Patients undergoing total hip arthroplasty following non-union of previous surgically treated fracture.
- •Infection, sepsis or osteomyelitis at the affected joint
- •Significant osteoporosis as defined by treating surgeon
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption on preoperative radiographs
- •Underwent contralateral THA within 12 months of planned index procedure
- •Contralateral THA planned within 12 months of index procedure
- •Vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease
- •The patient is
- •A prisoner
- •A known alcohol or drug abuser
- •The patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- •The patient is known to be pregnant
- •The patient has a known sensitivity or allergy to one or more of the implanted materials, inducing but not limited to chromium, cobalt, and ceramic
结局指标
主要结局
Survivorship of the study device
时间窗: 5 years
This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.
次要结局
- Radiographic measurements of the implanted device(10 years)
- Patient Physical Activity(10 years)
- Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device(10 years)
- Patient Quality of Life(10 years)
- Harris Hip Score(10 years)