经皮骨粘接剂应用于琼斯骨折不愈合或延迟愈合的“危险”:一种假设。

IF 2.6 Q1 SURGERY Patient Safety in Surgery Pub Date : 2022-12-02 DOI:10.1186/s13037-022-00348-3
Niaz Ahankoob, Vincent P Stahel
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引用次数: 1

摘要

背景:几十年来,骨胶粘剂一直处于骨科外科研究的前沿,因为它们可能在骨折治疗中具有潜在的益处。目前关于骨粘接剂的出版物和研究可以应用于我们目前的假设,为Jones骨折提供一种新的微创治疗选择。选择骨折的金标准治疗是非手术,但有并发症的风险,包括不愈合和延迟愈合。假设提出:我们假设经皮骨粘接剂的应用将为不需要手术固定的骨折模式提供额外的治疗选择,但将受益于额外的稳定性。主要观察指标为(1)骨巩固所需时间(定义为4个桥接皮质中的3个)和(2)缺勤时间(无法工作),以及手术后第一周内的疼痛程度。次要观察指标是不愈合或延迟愈合的发生率。我们假设选择骨粘接剂可以加速骨巩固,减少缺勤,减少手术后第一周内的疼痛程度,并减少延迟愈合和/或不愈合的发生率。假设检验:我们提出了一项前瞻性、多中心、随机、开放标签的临床试验,通过经皮注射骨粘接剂来检测急性非移位或轻度移位琼斯骨折。假设含义:骨粘接剂是骨折治疗的新前沿,目前处于实验室和动物试验阶段。合适的骨粘接剂配方尚未被批准用于临床试验,但骨粘接剂的意义可能不仅仅是减少并发症和易于稳定选定的闭合性骨折。如图1所示的可注射化合物,与非手术治疗相比,该粘合剂可以经皮应用,希望获得更好的结果。临床试验的总体目标是为患者提供一种安全的治疗选择,以提高非手术骨折的骨愈合率,而不是目前对相同骨折的金标准治疗,具有早期疼痛控制,早期骨巩固和较低延迟愈合/不愈合的风险。在未来的研究中,使用经皮骨粘接剂的理想患者群体是那些有多种医学合并症,手术风险大于手术收益的患者,以及基于骨折类型或系统生物学的骨不连高风险患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Percutaneous bone adhesive application for Jones fracture "at-risk" of nonunion or delayed union: a hypothesis.

Background: Bone adhesives have been on the forefront of orthopedic surgery research for decades due to the potential benefit they may have in fracture management. Current publications and research being conducted on bone adhesive could be applied to our current hypothesis for the benefit of a novel minimally invasive treatment option for a select cohort of fractures, Jones fractures. The select fracture's gold standard of treatment would be nonoperative, but with risk of complications including nonunion and delayed union.

Presentation of hypothesis: We hypothesize that percutaneous application of bone adhesive will provide an additional treatment option for fracture patterns that do not require operative fixation, but would benefit from additional stability. The primary outcome measures would be (1) duration of time required for bony consolidation (defined as 3 of 4 bridging cortices) and (2) duration of absenteeism (inability to work), and pain levels within the first week after the procedure. Secondary outcome measures would be the incidence of nonunion or delayed union. We hypothesize that the select bone adhesive would accelerate bony consolidation, decrease absenteeism, decrease pain levels within the first week after procedure, and decrease the incidence of delayed union and/or nonunion.

Testing of hypothesis: We propose a prospective multicenter, randomized, and open label trial clinical trial to test the bone adhesive via percutaneous injection into acute non-displaced or minimally displaced Jones fractures.

Implications of hypothesis: Bone adhesives are a new frontier in treatment of fractures, currently in laboratory and animal testing phases. The appropriate bone adhesive formula has not been approved for clinical trial use, but the implications of the bone adhesive may go beyond decreased complications and ease of stabilizing a select cohort of closed fractures. With the injectable compound illustrated (Fig. 1), the adhesive could be applied percutaneously in hopes of achieving improved outcomes compared to non-operative treatment. The overall goal of the clinical trial is to provide patients a safe treatment option for improved bone union rates of nonoperative fractures compared to the current gold standard management of the same fracture with earlier pain control, early bony consolidation and lower risk of delayed union/nonunion. The ideal patient population for use of a percutaneous bone adhesive in future studies would be for those with multiple medical comorbidities for whom surgical risks outweigh the benefits, in addition to patients at high risk for nonunion based on fracture pattern or systemic biology.

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来源期刊
CiteScore
6.80
自引率
8.10%
发文量
37
审稿时长
9 weeks
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