The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
赞助:
University of Calgary
合作者:
信息的提供 (责任方):
Prism Schneider，University of Calgary
| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | September 7, 2017 | ||
| 预计主要完成日期 | May 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Foot and Ankle Ability Measure (FAAM)[ Time Frame: 24 months ] Foot and Ankle Ability Measure (FAAM) at 24 months post initial Lisfranc surgery |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries | ||
| 正式标题 ICMJE | The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries | ||
| 简要概况 | Injuries to the midfoot tarsometatarsal joint, or Lisfranc joint, are notoriously debilitating. Poor functional outcomes following Lisfranc injuries have motivated surgeons to look for potential improvements in post-operative care. There are currently no evidence-based guidelines to direct implant removal for patients with operatively treated Lisfranc injuries. Routine implant removal has significant implications related to health care costs, lost time from work, potential surgical complications, and possibly functional impairment. Therefore, stakeholders including patients, surgeons, employers, and administrators will benefit from evidence-based guidelines for implant removal following operatively treated Lisfranc injuries. To date, there has not been a prospective randomized study evaluating the efficacy of implant removal compared with implant retention for Lisfranc injuries. The aim of this study is to directly compare patient-reported and radiographic outcomes, in order to provide robust evidence for optimal post-operative treatment regimens regarding implant removal or retention for operatively treated Lisfranc injuries. |
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| 详细说明 | This study is a multicenter, randomized clinical trial comparing implant retention (Retention Group) to scheduled implant removal (Removal Group) in 100 skeletally mature patients with Lisfranc injuries previously treated with screw and/or plate fixation. The primary outcome measure is the validated, patient-reported Foot and Ankle Ability Measure (FAAM) at 1-year post initial Lisfranc injury. Secondary outcome measures include: 1. American Orthopedics Foot and Ankle Midfoot Score (AOFAS), 2. patient-reported Visual Analogue Scale (VAS) for Foot and Ankle, 3. range of motion, 4. radiographic assessment of Lisfranc reduction, 5. comparative cost analysis between treatment groups. This study will follow patients for 1-year post-injury. Patients, surgeons, employers, and administrators will benefit from an evidence-based approach to implant removal following operatively treated Lisfranc injuries. This study will allow orthopaedic surgeons to counsel patients regarding the advantages and disadvantages of implant retention compared with removal. This study will provide robust data to inform clinical decision making for surgeons and provide patients with information regarding expected functional outcomes following Lisfranc injuries. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: This study is a multicenter randomized clinical trial comparing implant retention (Retention) to scheduled removal of implants (Removal) in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation. 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
100 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2021 | ||
| 预计主要完成日期 | May 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 18 years of age or older and skeletally mature - Subject has Lisfranc injury that was previously treated with screws and/or plate fixation within 21 days of initial injury - Subject must be enrolled in study within 6 weeks (+/-2 weeks) from time of initial fixation operation - The patient must be medically fit for anaesthesia - Subject is willing and able to provide written informed consent for trial participation - Subject is willing and able to comply with the study protocol including return for all follow-up evaluations Exclusion Criteria: - Subject has a significant pre-existing foot injury or deformity - There has been loss of fixation or reduction prior to enrollment - Subject was treated with a primary tarsometatarsal joint fusion - Subject has a delay in initial treatment greater than 21 days from time of injury - Subject has an active infection in the area of surgical approach - Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time - Subject has a history of rheumatoid arthritis, Diabetes, metabolic bone disease (including osteoporosis actively being treated), active malignancy, pathologic fracture or other pre-existing pathologic condition affecting the Lisfranc complex - Subject has a high risk of death from surgery (ASA physical status Class V) - Subject is likely unable to maintain follow-up - Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires - Subject is pregnant or planning on becoming pregnant in the following year | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Canada | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Prism Schneider，University of Calgary | ||
| 研究赞助商 ICMJE | University of Calgary | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | University of Calgary | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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