FOOT & ANKLE
Primary Open Reduction Internal Fixation Versus Primary Arthrodesis for Lisfranc Injuries: A Prospective Randomized Study
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(1):14 Foot Ankle Int. 2009 Oct;30(10):913-22.32 patients (25 at last follow-up) with acute tarsometatarsal joint fractures or fracture dislocations were randomized to receive primary arthrodesis (PA) or primary open reduction and internal fixation (PORIF). This study evaluated whether the PA procedure produced improved functional outcomes and fewer secondary surgeries. The results at all-time points (3, 6, 12, 24 months) indicated that there were no physical function differences reported for Short Form-36 (SF- 36) and Short Musculoskeletal Function Assessment (SMFA) scores. The PA procedure resulted in fewer planned/unplanned secondary surgeries compared to PORIF.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
2/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
The tarsal-metatarsal joint (TMT) or Lisfranc complex is a vital component in supporting the transverse arch of the midfoot. Dislocations and fracture-dislocations of the TMT are commonly associated with long term disability due to osteoarthritis or residual deformities. The authors suggest that PA may result in better functional outcomes and fewer follow-up surgeries when compared to primary ORIF. Therefore, this study aimed to compare the clinical and radiographic outcomes associated with these two treatment methods.
主な研究課題は何ですか？
Does PA treatment of patients with TMT injuries result in better functional outcomes and reduced rate of follow-up surgery when compared to traditional primary ORIF?
重要な知見は？
- No statistically significant differences in terms of physical function were seen on the SF-36 or SMFA scores at any follow up time points (p> 0.05)
- The rate of planned and unplanned follow-up surgeries was significantly different between the two groups: 78.6% in primary ORIF vs. 16.7% in PA (p< 0.05)
- The PA group showed a trend towards better SMFA index and SF-36 scores, however this only reached significance for the arm/hand index of the SMFA. At 3 months compared to the 6-, 12- and 24-month intervals, time had significant effect on improved physical functioning, decreased disability, and increased social functioning measured on the SF-36. It also had an effect on improved daily activity, mobility, and physical function, measured on the SMFA (p < 0.05).
- There were no significant differences in patient satisfaction between the groups, assessed via a telephone follow-up at 53 months (PORIF (9/10, 90%) versus PA (12/13, 92%); p>0.05).
- At 2 years, 14/14 (100%) of the patients in the PORIF group had anatomic reductions, whereas 17/18 patients (94%) in the PA group had solid fusion and anatomic reductions.
- At 2 years, 11 patients (79%) in the PORIF group required hardware removal surgery and 3 patients (17%) in the PA group required additional surgeries (3 hardware removals, one symptomatic screw, two hardware removals due to patient request). This difference was statistically significant (p<0.05).
- In terms of complications, there was one incidence of an asymptomatic broken screw in the PORIF group. In the PA group, complications included one delayed union (due to a broken screw), one non-union, one case of superficial cellulitis. In either group, there were no deep infections or neural injury.
最も覚えておくべきことは？
Both primary open reduction internal fixation (ORIF) and primary arthrodesis (PA), lead to improved functional outcomes in patients with tarsometatarsal joint fractures. However, PA significantly reduces the rate of secondary operations when compared to primary ORIF.
それが私の患者ケアにどのように影響するか？
Although this study suggests a decreased rate of follow-up operation in patients with primary arthrodesis, this study lacks a large sample size and has weak external validity.
免責事項
このページに記載されている内容は、情報提供のみを目的としたものであり、専門的な医療アドバイス、診断、治療の代わりとなるものではありません。治療が必要な場合は、必ず医師の診断を仰ぐか、最寄りの救急外来を受診してください。このページに記載されている内容に関して個人が表明した意見、信念、見解は、OrthoEvidenceの意見、信念、見解を反映するものではありません。
0の4 月間無料記事のロック解除
