ISRCTN96308751已完成未知
Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE): a multicenter randomized controlled trial
Stryker Trauma GmbH (Germany)0 个研究点目标入组 736 人开始时间: 2011年10月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 736
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/04/2012:
- •1. Adult men or women aged 18 years and older (with no upper age limit)
- •2. An intertrochanteric fracture (stable or unstable), AO Type 31-A1 or 31-A2, confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI)
- •3. Low energy fracture (defined as a fall from standing height)
- •4. No other major trauma
- •5. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker
- •6. Anticipated medical optimization of the patient for operative fixation of the proximal femur
- •7. Operative treatment within 7 days after the trauma (operative treatment should take place as soon as possible as permitted by each institution's standard of care)
- •8. Provision of informed consent by patient or proxy
- •Previous inclusion criteria:
- •1. Adult men or women aged 18 years and older (with no upper age limit)
- •2. A trochanteric fracture (stable or unstable) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI)
- •3. Low energy fracture (defined as a fall from standing height)
- •4. No other major trauma
- •5. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker
- •6. Anticipated medical optimization of the patient for operative fixation of the proximal femur
- •7. Operative treatment within 7 days after the trauma (operative treatment should take place as soon as possible as permitted by each institution's standard of care)
- •8. Provision of informed consent by patient or proxy
排除标准
- •Current exclusion criteria as of 05/04/2012:
- •1. Associated major injuries of the lower extremity (i.e. ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip)
- •2. Retained hardware around the affected proximal femur
- •3. Infection around the proximal femur (i.e. soft tissue or bone)
- •4. Patients with disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, or osteomalacia)
- •5. Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation
- •6. Patients with a subtrochanteric fracture
- •7. Patients with a pathologic fracture
- •8. Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3
- •9. Obesity in the judgment of the attending surgeon
- •10. Off-label use of the implant
- •11. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year)
- •12. Likely problems, in the judgment of the Site 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.
- •13. Patient is enrolled in another ongoing drug or surgical intervention trial
- •14. If the attending surgeon believes that there is another reason to exclude this patient from INSITE. This reason will be documented on the case report forms
- •Previous exclusion criteria:
- •1. Associated major injuries of the lower extremity (i.e. ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip)
- •2. Retained hardware around the affected proximal femur
- •3. Infection around the proximal femur (i.e. soft tissue or bone)
- •4. Patients with disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, or osteomalacia)
- •5. Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation
- •6. Patients with a subtrochanteric fracture
- •7. Patients with a pathologic fracture
- •8. Patients with a reverse oblique fracture pattern
- •9. Obesity in the judgment of the attending surgeon
- •10. Off-label use of the implant
- •11. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year)
- •12. Likely problems, in the judgment of the investigators, with maintaining followup. E.g. 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
- •13. Patient is enrolled in another ongoing drug or surgical intervention trial
- •14. If the attending surgeon believes that there is another reason to exclude this patient from INSITE. This reason will be documented on the case report forms
研究者
相似试验
终止
不适用
The impact of intramedullary (in the bone) nails versus sliding hip screws on health-related quality of life in patients with hip fractureACTRN12612000520831Stryker Australia Ptd Ltd736
已完成
不适用
Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE): a multicenter randomized controlled trialS72.1Pertrochanteric fractureDRKS00003342Stryker Osteosynthesis Clinical Research850
尚未招募
Unknown
Comparing Surgical Approaches for Displaced Hand Fractures: A Clinical Study of Intramedullary Screws versus Dorsal PlatesThe health condition studied is surgical procedures for displaced extra-articular metacarpal fractures.Injuries and Accidents - FracturesACTRN12624000003572Gold Coast Hospital and Health Services100
已完成
2 期
Plate Osteosynthesis Versus ESIN of Displaced Midclavicular FracturesClavicle FracturesNCT01015924University Hospital, Akershus125
已完成
不适用
Outcome of intra-medullary nailing compared to conventional plating in middle third clavicle fractures - a prospective randomized controlled trialInjury, Occupational Diseases, PoisoningMusculoskeletal DiseasesPatients with clavicle fracturesPACTR201805003376209Stellenbosch Univeristy100