TRAUMA
Open Reduction and Internal Fixation Compared with Circular Fixator Application for Bicondylar Tibial Plateau Fractures
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2025;13(3):41 J Bone Joint Surg Am. 2006 Dec;88(12):2613-23.82 patients with 83 displaced bicondylar tibial plateau fractures were randomized to receive standard open reduction and internal fixation with medial and lateral plates or percutaneous and/or limited open fixation and application of a circular fixator. At the 2 year follow-up there was no significant difference in clinical outcomes between the open reduction group and circular fixator group, however, a marginally faster return to function was observed at 6 months in the circular fixator group. Additionally, patients in the circular fixator group required a significantly shorter hospital stay than the patients in the internal fixation group, and the open reduction and internal fixation group exhibited significantly more complications.
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。
2/4
Randomization
2/4
Outcome Measurements
4/4
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？
Open reduction and internal fixation (ORIF) of bicondylar fractures of the tibial plateau is the current gold standard for treatment. However, damage caused by the original injury and the surgical procedure can lead to a high rate of complication. Alternative methods of treating bicondylar fractures of the tibial plateau have become increasingly common due to negative effects of complications associated with ORIF. One of these alternative treatments is circular frame fixation with or without percutaneous lag-screw fixation. This study aimed to determine whether percutaneous and/or limited open fixation and application of a circular fixator provides better fracture reduction quality than standard open reduction and internal fixation with medial and lateral plates.
主な研究課題は何ですか？
Does percutaneous and/or limited open fixation and application of a circular fixator improve clinical outcomes of patients with displaced bicondylar tibial plateau fractures when compared to open reduction and internal fixation with medial and lateral plates 2 years after surgery?
重要な知見は？
- At 6 months, the HSS knee score was 72 for the circular fixator group and 61 for the open reduction group (p=0.064). At 1 year the HSS knee score was 72 for the circular fixator group and 67 for the open reduction group (p=0.406). At 2 years, the HSS knee score was 75 for the circular fixator group and 68 for the open reduction group, which was found to be not statistically significant (p=0.307).
- The difference in mean pain, stiffness, or function on the WOMAC score between the circular fixator group and open reduction group at 6 months, 1 year, and 2 years was found to be not clinically significant (p>0.05), and no difference in total arc of knee motion was apparent (p>0.05).
- Both the circular fixator group and open reduction group achieved significantly lower mean WOMAC scores at the 2 year follow-up relative to preoperative scores (p<0.05).
- The difference between preoperative and 2 year follow-up SF-36 scores were found to be clinically significant for both the circular fixator group (p=0.001) and the open reduction group (p=0.014). At the 2 year follow-up, the difference between the circular fixator group and open reduction group was not significant for all SF-36 domains except for the bodily pain domain, which was significantly better for the circular fixator group (p=0.041).
- The circular fixation group required a significantly shorter hospital stay (9.9 days) than the open fixation group (23.4 days) (p=0.024) along with significantly less Intraoperative blood loss (213 mL vs. 544 mL respectively; p= 0.006).
- The quality of osseous reduction was similar between groups. Patient ability to return to preinjury activities at 6 months and 12 months was superior in the circular fixation group compared to the ORIF groups (p=0.031 and p=0.024 respectively) but not at 2 years.
- 7 (18%) ORIF patients reported a deep infection. The number of unplanned repeat surgical interventions, along with their severity, was greater in the ORIF group (37 procedures) compared with the circular fixator group (16 procedures) (p= 0.001).
最も覚えておくべきことは？
The data suggested that percutaneous and/or limited open fixation and application of a circular fixator did not significantly improve clinical outcomes of the knee but significantly reduced the required hospital stay when compared to standard open reduction and internal fixation with medial and lateral plates. Complications were also significantly more incident in the open reduction and internal fixation group.
それが私の患者ケアにどのように影響するか？
The study suggests that percutaneous and/or limited open fixation and application of a circular fixator may not significantly improve clinical outcomes when compared to standard open reduction and internal fixation with medial and lateral plates over a 2 year follow-up period. Further research using larger sample sizes are required to confirm the findings of this study.
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