Prospective Randomised Control Trial to Compare the Effect Upon Bone Density and Clinical Outcomes When Using BoneMaster HA Coated Acetabular Cups Compared With Plasma Sprayed HA Coated Cups in Patients With Total Hip Replacements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Record and Measure Bone Density Using DEXA Scans at 24 Months.
研究概览
简要总结
The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint to the bone is by coating the implant to encourage the body to grow bone onto the replacement hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce the incidence of early failures due to poor bony attachment, which is a well known complication for early failure of total hip replacements.
The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the cup of the replacement hip. Density of the bone immediately surrounding the cup will be observed to see if there are differences between the two groups. The density of bone will be measured using standard x-ray assessment and in a smaller sample of 14 patients, using a special scan called Dual Energy X-ray Absorptiometry (DEXA Scan). Functional comparisons will be assessed through clinical scores.
详细描述
The patients will be identified by the orthopaedic surgeon in the orthopaedic clinic and deemed suitable for the study if all inclusion and exclusion criteria are met. 210 patients will be recruited to the study and each patient will be randomised into either of the groups allowing 105 patients into each group. Patients will be followed up at 6 months, 1 year and 2 years after the surgery. All patients will have radiographic assessments at these follow-up intervals, as well as Harris Hip, Oxford Hip and Womac scores. This will allow comparison of the two groups.
The BoneMaster coating has been extensively tested in cell and animal studies and has been evaluated in one previous clinical study and showed favorable results. Further investigation is required to ensure the new coating may enhance bony growth allowing better fixation of the hips in the early period after the operation and also over a longer period of time. The growth needs to be measured using a more sensitive scan than radiographic assessment alone, called DEXA which was also used in the previous study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Plasma-sprayed shell
Exceed ABT plasma-sprayed hydroxyapatite coated acetabular cup.
干预措施: Plasma Coated Acetabular Shell (Device)
BoneMaster coated shell
Exceed ABT BoneMaster hydroxyapatite coated acetabular cup.
干预措施: BoneMaster coated acetabular shell. (Device)
结局指标
主要结局
Record and Measure Bone Density Using DEXA Scans at 24 Months.
时间窗: 2 years.
DEXA scan cohort - DEXA scan was used to measure bone density. Below is the calculated net average bone mineral density (BMD) percentage change from baseline at 2 years.
Radiography to Determine Radiolucency in All Three DeLee & Charnley Zones of the Acetabulum.
时间窗: 2 years.
34 patient cases without duplicated data were the basis for the radiographic analysis that was conducted: Bonemaster group, n = 12; Plasma-Sprayed group, n = 22. The degree of osseous-fixation was determined by grading: 1-2 mm radiolucencies, classed as not fixated; \>2mm radiolucencies, classed as unstable.
次要结局
- Secondary Outcomes Are Functional Assessment Using Harris Hip Score(2 years)
- Secondary Outcomes Are Clinical Assessment Using Oxford Hip Score(2 years.)
- Secondary Outcomes Are Clinical Assessment Using WOMAC Hip Score(2 years)