SPRINT- Randomized Trial of Tibial Fracture Fixation

SPRINT- 胫骨骨折固定的随机试验

• 批准号: 6732006
• 负责人: Marc F. Swiontkowski
• 金额: $ 30.1万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-05-28 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6732006
• 关键词: bone fracture; bone plates; bone transplantation; clinical research; clinical trials; fracture fixation; human subject; human therapy evaluation; implant; longitudinal human study; medical implant science; musculoskeletal disorder therapy; orthopedics; patient oriented research; tibia

DESCRIPTION (Taken from the application):Tibial fractures are the most common long bone fractures. Surgeons agree that intramedullary nails are the implant of choice when surgery is indicated. However, the decision to, ream or enlargen the intirarnedullary canal prior to nail insertion remains controversial. Proponents believe that reaming increases cortical bow blood flow increases the stability of the fracture fixation, and provides autogenous bone graft at the fracture site. Opponents believe that reaming damages the endosteal blood supply and threatens fracture healing. We, therefore, propose a randomized trial of reamed vs nonreamed intramedulary insertion in 900 patients with dosed or open tibial shaft fractures. Eligible patients receive 1) reaming of the intramedullary canal prior to insertion of an intramedullary nail or 2) insertion of an intramedullary nail without prior reaming of the intramedullary canal. Surgeons will follow a strict protocol in managing patients in both groups. The protocol will include proscription to re-operation prior to six rnonths. The rate of re-operations aimed at improving fracture healing (bone grafting, nail exchange or removal, soft tissue coverage procedures) will be determined at 6 months, 9 months and one year. Secondary outcomes will Include return to work, functional status and health-related quality of life. The large size of the trial will reveal a more reliable and precise estimate of the true effect of both treatments. The results from this trial will be useful in guiding clinical practice.

描述（摘自应用程序）：胫骨骨折是最常见的 长骨骨折外科医生一致认为髓内钉是植入物 当需要手术时，可以选择。然而，决定扩大或扩大 髓内钉插入前的髓内管仍有争议。 支持者认为，扩髓增加皮质弓血流量， 骨折固定的稳定性，并提供自体骨移植在 骨折部位反对者认为扩髓损伤了骨内膜血液 供应并威胁骨折愈合。因此，我们提出了一个随机的 在900例患者中进行的扩髓与非扩髓内插入试验， 或开放性胫骨干骨折合格患者接受1）扩髓 在插入髓内钉之前插入髓内管，或2） 插入髓内钉而无需预先扩髓 运河外科医生将遵循严格的协议来管理这两个国家的病人。 组该协议将包括禁止在六点之前再次手术。 rnonths。旨在改善骨折愈合的再次手术率（骨 移植、指甲交换或移除、软组织覆盖手术）将被 在6个月、9个月和1年时测定。次要结局将包括 恢复工作、功能状态和与健康有关的生活质量。大 试验的规模将揭示一个更可靠和准确的估计， 两种治疗的效果。这项试验的结果将有助于 指导临床实践。