A Prospective, Observational, Multi-centre, Cohort Study of the G7™Acetabular System Used With Compatible Femoral Stems in Patients With Degenerative Disease of the Hip
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Survival of the implant system
研究概览
简要总结
A prospective , observational, multi-centre, cohort study of the G7™ Acetabular System used with compatible femoral stems in patients with degenerative disease of the hip.
The study will be enrolled onto Beyond Compliance.
详细描述
The UK Beyond Compliance is a joint effort between implant manufacturers, implanting surgeons adopting our products, and the Beyond Compliance Advisory Group, all of whom are looking to ensure the safe and stepwise introduction of new or modified implants to the market in the interest of patients.
The G7 Acetabular Cup System is Biomet multi-bearing acetabular platform with a wide range of acetabular shell options recently launched. There is a need to provide evidence on the safety and performance of this cup to support the product in different markets.
The purpose of this multicenter study is to assess the clinical performance of the G7 acetabular system under standard condition of use. The data will help Biomet to gain 3A ODEP rating in 4 years and up to 10 year rating
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ≥18 years
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement;
- •Rheumatoid arthritis;
- •Correction of functional deformity;
- •Voluntary written Informed Consent obtained
- •Exclusion Criteria
- •Pre-operative:
- •Prospect for recovery to independent mobility compromised by known coexistent medical problems;
- •Requiring revision hip replacement;
- •Requiring bilateral hip replacement;
- •Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
- •Likely post-operative leg length inequality >5cm;
- •Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity);
- •Primary or metastatic tumour involving this hip;
- •Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
- •Previous organ transplant;
- •Previous arthrodesis or excision arthroplasty
- •Abnormal acetabulum:
- •Acetabular deficiency - >2cm superior loss acetabular dome or >1.5cm protrusion acetabulae or wall deficiency> half a wall;
- •Dysplasia (DDH) with >2.5cm subluxation or complete dislocation;
- •Body mass index > 40kg/m2;
- •Active or previous or suspected infection in this hip;
- •Sepsis or osteomyelitis;
- •Known sensitivity to device materials;
- •Women judged by the investigator to be of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period;
- •Unable to provide informed consent (insufficient English, cognitive disorder such as dementia, psychiatric illness);
- •Unable to complete follow-ups (life expectancy <5 years, insufficient English, lives overseas, unable to return easily).
- •Intra-operative:
- •Abnormal abductor mechanism - trochanter escape > 1.5cm or gluteus medius totally non-functional or trochanter absence;
- •Unavailability of required size of prosthesis;
- •Abnormal acetabulum:
- •Acetabular deficiency - >2cm superior loss acetabular dome or >1.5cm protrusion acetabulae or wall deficiency> half a wall;
- •Dysplasia (DDH) with >2.5cm subluxation or complete dislocation.
排除标准
- 未提供
结局指标
主要结局
Survival of the implant system
时间窗: 10 years post-surgery
Survival of the implant based on removal or intended removal of any component
次要结局
- EQ-5D-3L VAS(pre-op, 6 Months, 1 Year, 3 Year)
- Hip disability and Osteoarthiritis Outcome Score (HOOS)(pre-op, 6 Months, 1 Year, 3 Year)
- Radiographic assessment(post-op, 2-8 weeks, 1 Year, 3 Year)
- Oxford Hip Score(pre-op, 6 Months, 1 Year, 3 Year)
- Harris Hip Score(pre-op, 1 Year, 3 Year)
- EQ-5D-3L score(pre-op, 6 Months, 1 Year, 3 Year)
- Safety of the implant system(10 years post-surgery)