EUCTR2006-001916-54-SE进行中（未招募）不适用
A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects signed and dated IRB or IEC-approved informed consent form.
- •2. Skeletally mature and aged >= 18 years (closed epiphysis)
- •3. Subjects with a either a closed proximal humeral fracture or a diaphyseal humerus fracture classified as:
- •- Proximal Humeral Fracture (NEER classification): nondisplaced, minimally displaced (<45° angluation and <1cm displaced), 2-Part, 3-Part or 4-Part
- •- Diaphyseal Humeral Fracture (OTA classification): Simple OTA 12-A- Wedge OTA 12-B or Complexe OTA 12-C
- •4. Treatment plan includes only conservative (non-operative) therapy within 48 hours of injury.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Open proximal or humeral shaft fractures.
- •2. Additional planned procedure(s) to stimulate fracture union following application of an initial immobilization device.
- •3. Shoulder dislocation at the time of injury.
- •4. Fractures located in the distal third of the humerus.
- •5. Concurrent fractures of the ipsilateral or contralateral upper extremity that would impede performance on a functional assessment.
- •6. Treatment initiated for osteoporosis within the past 16 weeks.
- •7. Any previous use of therapies that can be considered bone anabolic (parathyroid hormone, growth hormone, anabolic steroids or fluoride at bone therapeutic doses) within the past year.
- •8. Pathological fractures, except if due to postmenopausal or senile osteoporosis
- •9. Documented history of amlignacy, except basal or squalmous carinoma that has been treated and has fully resolved for a minimum of 5 years.
- •10.Retained surgical hardware in the humerous under study due to previous fracture.
研究者
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