NCT02030431终止不适用
Dynaloc vs. Multiple Cancellous Screws for Treatment of Femoral Neck Fractures
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Shortening of the femoral neck
研究概览
简要总结
A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures
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
- 年龄范围
- 50 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women (see age specifications below) with subcapital femoral neck fractures (stable or unstable) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- •Patients between 50 and 69 years of age with any Garden type femoral neck fracture
- •Patients older than 70 years of age with femoral neck fractures Garden type I and II
- •Patients older than 70 years of age with a femoral neck fracture Garden types III and IV and contraindication to hemiarthroplasty.
- •Operative treatment within 4 days (i.e., 72 hours) of presenting to the emergency room.
- •Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- •Anticipated medical optimalization of the patient for operative fixation of the hip.
- •Provision of informed consent by patient or proxy.
- •Low energy fracture (defined as a fall from standing height).
- •No other major trauma.
排除标准
- •Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- •Retained hardware around the affected hip.
- •Abnormal opposite hip making end-point evaluation impossible
- •Infection around the hip (i.e., soft tissue or bone).
- •Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy).
- •Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors).
- •Patients with Parkinson's disease (or dementia or other neurological deficit) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- •Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
结局指标
主要结局
Shortening of the femoral neck
时间窗: 1 year
次要结局
- Reoperation(1 year)
研究者
Lars C. Borris
Consultant of Orthopaedic surgery
Aarhus University Hospital
研究点 (2)
Loading locations...
相似试验
终止
4 期
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate FixationDistal Femur FracturesNCT01693367AO Innovation Translation Center5
招募中
不适用
EVALUATION OF TWO DIFFERENT ATTACHMENT SYSTEMS IN MANDIBULAR OVERDENTURES RETAINED WITH TWO INCLINED IMPLANTSInclined ImplantsNCT05695612Alexandria University22
进行中（未招募）
不适用
Assessment of Novaloc and Locator Attachment SystemsCompletely Edentulous MaxillaNCT06011031Ain Shams University14
招募中
不适用
Clinical and Economic Comparison of 2 Methods of Intubation Tube Fixation : AnchorFastTM Versus Current Cord FixationIntubation ComplicationEscharNCT06533436Hopital Foch350
已完成
不适用
Use of Interlocking Detachable Coils System in Embolization of Peripheral Arterial EmbolizationPeripheral Arterial DiseaseNCT05391399Shanghai Shenqi Medical Technology Co., Ltd121