Retrospective and Prospective Multi-Center Outcomes Study of G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 275
- 试验地点
- 7
- 主要终点
- Implant dislocation rate
研究概览
简要总结
This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.
详细描述
The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 to 80 years of age, inclusive
- •Skeletally mature
- •Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
- •Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
- •Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- •Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent
排除标准
- •Is septic, has an active infection or has osteomyelitis at the affected joint
- •Has significant osteoporosis as defined by treating surgeon
- •Has metabolic disorder(s) which may impair bone formation
- •Has osteomalacia
- •Has distant foci of infections which may spread to the implant site
- •Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
- •Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
- •Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- •Is known to be pregnant
- •Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
- •Has a known sensitively or allergy to one or more of
结局指标
主要结局
Implant dislocation rate
时间窗: One year post-surgery
Dislocation is defined as the complete loss of articulation contact between two artificial joint components.
次要结局
- Implant survivorship by revision rates(Up to 5 years post-surgery)
- Pain and Functional Performance by Oxford Hip Score(Up to 5 years post-surgery)
- Quality of life by JHEQ(Up to 5 years post-surgery)
- Quality of life by EQ-5D-5L questionnaire(Up to 5 years post-surgery)
- Pain and Functional Performance by JOA Hip Score(Up to 5 years post-surgery)
- Adverse events reported(Up to 5 years post-surgery)