SPRINT- Randomized Trial of Tibial Fracture Fixation

SPRINT- 胫骨骨折固定的随机试验

• 批准号: 7169352
• 负责人: Marc F. Swiontkowski
• 金额: $ 7.35万
• 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/7169352
• 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（取自应用）：胫骨骨折是最常见的

项目成果

Reamed compared with unreamed nailing of tibial shaft fractures: Does the initial method of nail insertion influence outcome in patients requiring reoperations?

• DOI: 10.1503/cjs.012222
• 发表时间: 2023-07
• 期刊: Canadian journal of surgery. Journal canadien de chirurgie

Economic evaluation of reamed versus unreamed intramedullary nailing in patients with closed and open tibial fractures: results from the study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT).

闭合性和开放性胫骨骨折患者铰髓内钉与未铰髓内钉的经济评估：前瞻性评估胫骨骨折患者铰髓内钉的研究结果（SPRINT）。

• DOI: 10.1016/j.jval.2010.10.034
• 发表时间: 2011
• 期刊: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
• 作者: SPRINTInvestigators;Briel,Matthias;Sprague,Sheila;Heels-Ansdell,Diane;Guyatt,Gordon;Bhandari,Mohit;Blackhouse,Gordon;Sanders,David;Schemitsch,Emil;Swiontkowski,Marc;Tornetta3rd,Paul;Walter,StephenD;Goeree,Ron
• 通讯作者: Goeree,Ron

Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design.

• DOI: 10.1186/1471-2474-9-91
• 发表时间: 2008-06-23
• 期刊: BMC MUSCULOSKELETAL DISORDERS
• 影响因子: 2.3

Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial.

参与随机临床试验会改变结果吗？

• DOI: 10.1097/bot.0000000000000533
• 发表时间: 2016
• 期刊: Journal of orthopaedic trauma
• 影响因子: 2.3
• 作者: Lin,CarolAlice;Bhandari,Mohit;Guyatt,Gordon;Walter,StephenD;Schemitsch,EmilH;Swiontkowski,Marc;Sanders,David;Tornetta3rd,Paul;SPRINTInvestigators
• 通讯作者: SPRINTInvestigators

(Sample) size matters! An examination of sample size from the SPRINT trial study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures.

• DOI: 10.1097/bot.0b013e3182647e0e
• 发表时间: 2013-04
• 期刊: Journal of orthopaedic trauma
• 影响因子: 2.3
• 作者: SPRINT Investigators;Bhandari M;Tornetta P 3rd;Rampersad SA;Sprague S;Heels-Ansdell D;Sanders DW;Schemitsch EH;Swiontkowski M;Walter S
• 通讯作者: Walter S