A Prospective, Randomized Study of Summit™ Porocoat® Versus Summit™ DuoFix™ HA in Cementless Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- Harris Hip Score (HHS)
研究概览
简要总结
Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty
详细描述
Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total hip replacement
- •Patient age less than or equal to 75
- •Sufficient bone stock to support prosthesis
排除标准
- •Previous hip replacement
- •Significant angular/bony deformity
- •Active joint sepsis
- •Metal allergy
- •Renal transplant
- •Psychosocial disease
- •Neurological disease/musculoskeletal disease that may affect weight-bearing
结局指标
主要结局
Harris Hip Score (HHS)
时间窗: Preoperative, 6, 12, 24, 36, 48, and 60 months
The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 90-100 is excellent, 80-90 is good, 70-80 is fair, 60-69 is poor, and 60 or below is failed. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comforatably sit in a chair are all scored. The doctor assesses patient hip function by testing flexion, extension, adduction and abduction.
次要结局
- Medical Imaging as a Secondary Outcome Inclusive of All Post-operative Intervals for All Participants at Study Closure.(Postoperative, 6, 12, 24, 36, 48 and 60 months)