Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem: Five-Year Results Of A Prospective, Randomized DEXA-Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 主要终点
- Stem specific stress shielding of a short compared to a straight hip stem
研究概览
简要总结
The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the proximal femur after implantation of the Fitmore compared to the CLS stem.
详细描述
After power analysis, 140 consecutive patients were prospectively included in the randomisation protocol receiving either a Fitmore short or a CLS straight stem. The short stem was assigned in 57 (37% females) cases and the straight stem in 83 (38% females) hips. Periprosthetic bone mineral density was measured before surgery, 7 days, 3, 12 and 60 months postoperatively, using dual energy x-ray absorptiometry (DEXA). The results of the first postoperative measurement served as the baseline value. Because of the different length of the two prostheses we used adapted Gruen zones to divide the periprosthetic bone in seven regions of interest (ROI) with equal length in the proximal zones 1,2,6 and 7, only the regions 3 and 5 featured different sizes. Clinical results were recorded using the WOMAC and the Harris hip score (HHS).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary osteoarthritis of the hip
- •written informed consent
- •indication for cementless total hip arthroplasty
排除标准
- •previous surgery in the same hip
- •femoral fracture
- •metabolic bone disease
- •drugs affecting bone quality
- •contralateral THA within the study period
- •infectious disease or bony tumor
结局指标
主要结局
Stem specific stress shielding of a short compared to a straight hip stem
时间窗: Five years postoperatively
Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem
次要结局
- Clinical Outcome after short compared to straight stem THA(Five years postoperatively)
研究者
PD Dr. med Ralf Bieger
PD Dr. med
University Hospital Ulm