Prospective Exploratory Study:Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Bone mineral density changes
研究概览
简要总结
Prospective explorative study for the investigation of short-term and medium-term outcomes regarding bone mineral density changes after revision hip arthroplasty making use of bone impaction grafting. Outcome measurements will include objective and subjective clinical data, complications and adverse events, radiographic data measurements recorded at several postoperative intervals.
详细描述
Hypothesis, open questions and specific aims of the project:
We believe that it is important to gain further insight in the process of bone graft remodeling and the preservation of bone stock after bone impaction grafting.
Radiographs are far from conclusive and CT scan can not be repeated on regular intervals for obvious reasons. Prospective follow-up of the BMD of the bone impaction area will contribute to our further understanding. There is no literature available on BMD changes in the acetabulum after bone impaction grafting.
From our recent experiences with earlier research on BMD in specific ROI in the femoral neck we are motivated to further explore the potential of our DEXA technology and software in the field revision hip arthroplasty.
We hypothesize that BMD changes in the bone impaction grafted acetabulum can be adequately monitored with modern DEXA techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •revision hip arthroplasty with acetabular defects eligible for bone impaction grafting
- •Diagnosis: acetabular osteolytic defects after primary total hip arthroplasty, planned for revision hip arthroplasty with bone impaction grafting.
- •Patient is between 35 and 75 years old.
- •Patient is expected to recover completely.
- •Patient is willing and able to come to follow-up examinations.
- •Patient has signed an informed consent.
排除标准
- •Infection of the hip joint or distant infection (may cause hematogenous spread to the implant site)
- •Hip fractures
- •Patient is younger than 35 years or older than 75 years.
- •Patient is not willing and/or able to come to follow-up examinations
- •Patient has not signed an informed consent
- •Relative contra-indications:
- •With regard to the patient's general health:
- •Metabolic disorders or medication (e.g. steroids) which may impair bone formation
- •Osteomalacia
- •Disorders of the immune system, caused by disease or immunosuppressive medication which increase the risk of infection.
- •Poor prognosis for good wound healing: decubitus ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition
研究组 & 干预措施
Bone Mineral Density
Bone mineral density measurement with "intervention" DEXA at the bone impaction graft site:
DEXA: dual energy X-ray absorptiometry
干预措施: DEXA: dual energy X-ray absorptiometry (Radiation)
Hip function
Hip Function/mobility development:
Harris Hip Score
干预措施: Harris Hip Score (Other)
pain experience
Pain experiences after surgery in the hip joint VAS-pain
干预措施: VAS-pain (Other)
General Patients Health condition
Patients health condition monitoring: intervention SF12:
Short Form Health Survey 12
干预措施: Short Form Health Survey 12 (Other)
Intervention Satisfaction
Patients satisfaction development after the intervention VAS-satisfaction
干预措施: VAS-satisfaction (Other)
结局指标
主要结局
Bone mineral density changes
时间窗: 24 months
Acetabular bone mineral density measurements after bone impaction grafting using DEXA, changes in density compared to baseline levels: at \< 2weeks postoperative, at 3, 6, 12 and 24 months postoperative
次要结局
未报告次要终点
研究者
Job van Susante
MD, PhD
Rijnstate Hospital