The Effect of Combined Drug Therapy in Lateral Fragility Fractures of the Femur:a Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Visual Analogic Scale
研究概览
简要总结
It was conducted a prospective study with a series of 50 patients treated by intramedullary nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with the same fractures treated with Vitamin D alone (control group including 25 patients).
One independent observer performed clinical, biochemical and functional evaluations at T0 (1st day post-surgery) and at T1 (12 months later) Biochemical markers (serum calcium level, serum phosphate level, PTH (parathormone), Vitamin D, serum C-terminal telopeptide), VAS (Visual Analogic Scale) and HHS (Harris Hip Score) score, and femur densitometric views were administered at each evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •femur fractures type 31-A1, A2, (Muller ME, Nazarian S, Kock P et al.);
- •age 60 - 85 years;
- •co-operative patients;
- •Body Mass Index (BMI) < 30 Kg/m²;
- •patients treated by intramedullary nailing surgery (PFNA Synthes®);
- •patients with osteoporosis disease if T-Score< -2,5;
排除标准
- •patients with heart, kidney, neurological diseases;
- •patients with metabolic and systemic disease (rheumatoid arthritis, diabetes mellitus);
- •previous surgery or severe osteoarthritis of lower limbs;
- •specific drugs treatments such as anticoagulants or psychiatric drugs.
研究组 & 干预措施
patients treated with Vitamin D and Clodronic Acid
干预措施: Clodronic Acid (Drug)
结局指标
主要结局
Change in Visual Analogic Scale
时间窗: Day 1; Month 12 (after surgey)
The Hip Pain was quantified using the Visual Analogic Scale ranging between 0 (no pain) and 10 points (worst imaginable pain).
次要结局
未报告次要终点