NCT05677061已完成不适用
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Lag Screw migration measured as y-translation (mm)
研究概览
简要总结
Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures
详细描述
Randomised study to determine the effect of HA coating on the stability of dynamic Hip screws used to stabilize femoral neck fractures. Stability of the screw will be determined by RSA measurements. Additionally the fracture stability will be evaluated by RSA measurements.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable intertrochanteric femoral fractures (Evans I, II, IV)
- •able to speak Danish
- •able to complete the postoperative controls
- •written consent
排除标准
- •unable to follow standard hip fracture regime
- •were breastfeeding
- •terminal disease
- •in need of open fracture reduction
- •in need of DHS plate with an angle different from 135 degrees
- •insertion of fewer than 3 tantalum beads in the femoral head (for RSA)
- •TAD >20mm in two dimensions in the first postoperative x-ray
- •fracture displacement >20mm in two dimensions in the first postoperative x-ray
结局指标
主要结局
Lag Screw migration measured as y-translation (mm)
时间窗: 6 months PO
Lag screw migration measured as y-translation (mm) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up
次要结局
- Clinical outcomes - NMS(Preoperative)
- Clinical outcomes - Leg Lengths difference(6 months)
- Lag screw migration measured as rotations in degrees(6 months PO)
- Radiological measurements(6 months)
- Lag screw migration measured as translations in mm(6 months PO)
- Clinical outcomes - HHS(6 months PO)
- Clinical outcomes - TUG test(6 months)
研究者
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