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本文引用的文献

1
Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter?骨科随机试验中的结果报告:结果评估者的盲法是否重要?
J Bone Joint Surg Am. 2007 Mar;89(3):550-8. doi: 10.2106/JBJS.F.00683.
2
Intramedullary nailing of proximal quarter tibial fractures.胫骨近端四分之一骨折的髓内钉固定术。
J Orthop Trauma. 2006 Sep;20(8):523-8. doi: 10.1097/01.bot.0000244993.60374.d6.
3
Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial.重组人骨形态发生蛋白-2与同种异体骨移植对比自体骨移植用于重建伴有皮质缺损的胫骨干骨折:一项随机对照试验。
J Bone Joint Surg Am. 2006 Jul;88(7):1431-41. doi: 10.2106/JBJS.E.00381.
4
Does open reduction increase the chance of infection during intramedullary nailing of closed tibial shaft fractures?切开复位会增加闭合性胫骨干骨折髓内钉固定期间的感染几率吗?
J Orthop Trauma. 2006 May;20(5):317-22. doi: 10.1097/00005131-200605000-00004.
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A randomized, controlled trial of distal radius fractures with metaphyseal displacement but without joint incongruity: closed reduction and casting versus closed reduction, spanning external fixation, and optional percutaneous K-wires.一项关于伴有干骺端移位但无关节不匹配的桡骨远端骨折的随机对照试验:闭合复位及石膏固定与闭合复位、跨越外固定及选择性经皮克氏针固定的对比
J Orthop Trauma. 2006 Feb;20(2):115-21. doi: 10.1097/01.bot.0000199121.84100.fb.
6
An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods.一项观察性研究发现,随机对照试验的作者经常使用随机化隐藏和盲法,尽管他们并未报告这些方法。
J Clin Epidemiol. 2004 Dec;57(12):1232-6. doi: 10.1016/j.jclinepi.2004.03.017.
7
The less invasive stabilization system in the treatment of complex fractures of the tibial plateau: short-term results.微创稳定系统治疗胫骨平台复杂骨折的短期结果。
J Orthop Trauma. 2004 Sep;18(8):552-8. doi: 10.1097/00005131-200409000-00012.
8
Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials.与药物试验相比,在非药物试验中,盲法被认为更难实现和维持。
J Clin Epidemiol. 2004 Jun;57(6):543-50. doi: 10.1016/j.jclinepi.2003.12.010.
9
Reliability of radiographs in defining union of internally fixed fractures.X线片在确定内固定骨折愈合方面的可靠性。
Injury. 2004 Jun;35(6):557-61. doi: 10.1016/S0020-1383(03)00262-6.
10
Intramedullary nailing of humeral shaft fractures with a locking flexible nail.使用锁定弹性髓内钉治疗肱骨干骨折
J Bone Joint Surg Am. 2003 Nov;85(11):2103-10. doi: 10.2106/00004623-200311000-00007.

骨科创伤研究中骨折愈合评估的变异性。

Variability in the assessment of fracture-healing in orthopaedic trauma studies.

作者信息

Corrales Luis A, Morshed Saam, Bhandari Mohit, Miclau Theodore

机构信息

Department of Orthopaedic Surgery, University of California at San Francisco School of Medicine, 500 Parnassus Avenue, MU-320W, San Francisco, CA 94143, USA.

出版信息

J Bone Joint Surg Am. 2008 Sep;90(9):1862-8. doi: 10.2106/JBJS.G.01580.

DOI:10.2106/JBJS.G.01580
PMID:18762645
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2663323/
Abstract

BACKGROUND

There is a lack of consensus among orthopaedic surgeons in the assessment of fracture-healing. We conducted a systematic review of recent clinical studies of long-bone fracture care that were published in three major orthopaedic journals to identify current definitions of fracture-healing.

METHODS

MEDLINE and the computerized databases for The Journal of Bone and Joint Surgery (American Volume), The Journal of Bone and Joint Surgery (British Volume), and the Journal of Orthopaedic Trauma were searched from January 1996 through December 2006 with use of title, abstract, keyword, and medical subject headings. Therapeutic clinical studies of long-bone fractures of the appendicular skeleton in adults in which fracture-healing was assessed were selected. Two reviewers independently identified articles and extracted data. Any disagreement was resolved by consensus. We qualitatively and quantitatively summarized the definition of fracture union and the reliability of the assessment of radiographic fracture-healing.

RESULTS

One hundred and twenty-three studies proved to be eligible. Union was defined on the basis of a combination of clinical and radiographic criteria in 62% of the studies, on the basis of radiographic criteria only in 37%, and on the basis of clinical criteria only in 1%. Twelve different criteria were used to define fracture union clinically, and the most common criterion was the absence of pain or tenderness at the fracture site during weight-bearing. In studies involving the use of plain radiographs, eleven different criteria were used to define fracture union, and the most common criterion was bridging of the fracture site. A quantitative measure of the reliability of the radiographic assessment of fracture union was reported in two studies.

CONCLUSIONS

We found a lack of consensus with regard to the definition of fracture-healing in the current orthopaedic literature. Without valid and reliable clinical or radiographic measures of union, the interpretation of fracture care studies remains difficult.

摘要

背景

骨科医生在骨折愈合评估方面缺乏共识。我们对发表于三本主要骨科期刊上的近期长骨骨折治疗临床研究进行了系统评价,以确定当前骨折愈合的定义。

方法

通过标题、摘要、关键词和医学主题词,检索1996年1月至2006年12月期间的MEDLINE以及《骨与关节外科杂志》(美国版)、《骨与关节外科杂志》(英国版)和《骨科创伤杂志》的计算机数据库。选择评估成人四肢骨骼长骨骨折愈合情况的治疗性临床研究。两名 reviewers 独立识别文章并提取数据。任何分歧均通过协商解决。我们定性和定量地总结了骨折愈合的定义以及放射学骨折愈合评估的可靠性。

结果

123项研究符合要求。62% 的研究根据临床和放射学标准的组合来定义愈合,37% 仅根据放射学标准,1% 仅根据临床标准。临床上用于定义骨折愈合的标准有12种不同的标准,最常见的标准是负重时骨折部位无疼痛或压痛。在涉及使用普通X线片的研究中,用于定义骨折愈合的标准有11种不同的标准,最常见的标准是骨折部位骨痂形成。两项研究报告了骨折愈合放射学评估可靠性的定量测量。

结论

我们发现当前骨科文献中关于骨折愈合的定义缺乏共识。如果没有有效且可靠的临床或放射学愈合测量方法,骨折治疗研究的解读仍然困难。