SPRINT- Randomized Trial of Tibial Fracture Fixation

SPRINT- 胫骨骨折固定的随机试验

• 批准号: 6458137
• 负责人: Marc F. Swiontkowski
• 金额: $ 35.81万
• 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 2005-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6458137
• 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(摘自申请)：胫骨骨折是最常见的 长骨骨折。外科医生同意髓内钉是植入物 在需要手术的情况下可以选择。然而，决定是扩大还是扩大 髓内钉植入前的髓内管仍存在争议。 支持者认为，扩髓增加了皮质弓的血流量，增加了 骨折固定的稳定性，并在骨折端提供自体骨移植 骨折部位。反对者认为扩髓会损害骨内血液。 供应和威胁骨折愈合。因此，我们建议一种随机化的 扩髓髓内植入与非扩髓髓内植入的对比试验 或开放性胫骨骨折。符合条件的患者将获得1)扩髓 在置入髓内钉之前的髓内管或2) 无需事先扩髓髓内钉即可插入髓内钉 卡纳尔。外科医生将遵循严格的规程来管理这两个区域的病人。 组。该议定书将包括禁止在六点之前重新操作 胡说八道。旨在改善骨折愈合(骨)的再手术率 移植、换指甲或取出指甲、软组织覆盖手术) 分别在6个月、9个月和1年时确定。次要结果将包括 重返工作岗位、功能状态和与健康相关的生活质量。大的 试验的规模将揭示对真实情况的更可靠和更准确的估计 两种治疗方法的效果。这项试验的结果将对 指导临床实践。