FOOT & ANKLE
Outcomes of operative treatment of unstable ankle fractures: a comparison of metallic and biodegradable implants
この研究はハイインパクトの可能性があります。
OEのAI駆動型ハイインパクト指標は、論文が掲載されたジャーナルと論文自体の科学的内容の両方からのシグナルを統合することで、論文が持つ可能性の高い影響力を推定します。
最先端の自然言語処理を用いて開発されたOEハイインパクトモデルは、ジャーナルのインパクトファクターのみよりも、研究の将来の引用実績をより正確に予測します。
これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(6):38 J Bone Joint Surg Am. 2012 Nov 21;94(22):e1661-7. doi: 10.2106/JBJS.K.01221109 patients with unstable ankle fractures, requiring surgical intervention, were included in this study to compare clinical outcomes of metal and biodegradable implant fixations. Patients who underwent fixation using a metal implant had a shorter mean operative time, required less time to bone union, and had superior American Orthopaedic Foot and Ankle Society ankle-hindfoot scale scores at 12 months. Patients in the metal implant group also had fewer non-unions when compared to the biodegradable implants; however, this difference was not significant.
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
Aleatorización
2/4
Medidas de resultado
4/4
Inclusión/Exclusión
4/4
Descripción del tratamiento
4/4
Estadística
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？
Due to the complexity of displaced ankle fractures surgical reduction and fixation are required to ensure the best functional recovery. Metallic implants are often used to provide adequate stability; however, metallic implants have a number of theoretical and practical disadvantages, including stress shielding and the need for possible secondary operations to remove the implant. The use of biodegradable implants, as an alternative for internal fixator for ankle fractures, was introduced in the 1980's, and the advent of new technologies have led to the development of numerous biodegradable materials - each with different characteristics. Comparisons between biodegradable implants made of polylevolactic acid and metallic implants for fixations of displaced ankle fractures have yet to be conducted using a randomized trial.
主な研究課題は何ですか？
Does the use of biodegradable implants, made of polylevolactic acid, provide similar clinical and functional outcomes compared to the use of metallic implants for the fixation of unstable ankle fractures, assessed over a 12 month period?
重要な知見は？
- The mean operative time in group 1 (Metal) was 30.2 +/- 4.5 minutes compared to the mean operative time of 56.6 +/- 10.7 minutes (p<0.001) in group 2 (Bio)
- There were no differences in the reduction of medial malleolus, lateral malleolus, posterior malleolus, and syndesmosis. 6 of 12 patients in group 2 (Bio) with medial malleolar fractures had a fracture gap postoperatively or during follow-up.
- Mean time to bone union was significantly shorter in group 1 (Metal) compared to group 2 (Bio) (p=0.002): 15.8 weeks and 17.6 weeks, respectively.
- Mean AOFAS scores were greater in group 1 (Metal): 87.5+/-3.8 compared to group 2 (Bio): 84.3+/-6.6 (p=0.004)
- There were no differences SMFA dysfunction and bother indexes between the two groups (p=0.06 and 0.052, respectively); although, there was a trend present towards better scores in group 1 (Metal).
- A subgroup of patients with lateral malleolar fractures did not demonstrate differences in clinical outcomes between groups.
- There were two non-unions in group 2 (Bio) and none in group 1 (Metal) (p=0.228)
- 18 of 53 patients in group 1(Metal) had hardware removal surgery.
最も覚えておくべきことは？
Fixation of unstable ankle fractures with metal implants required significantly less operative time, resulted in shorter time to radiographic union, and superior AOFAS scores;however, it is unclear if this difference in AOFAS scores was clinically relevant. The use of a metallic implant also resulted in fewer non-unions, but this difference was not significant.
それが私の患者ケアにどのように影響するか？
Metal implants provide superior outcomes for unstable ankle fractures compared to biodegradable implants made of polylevolactic acid. The use of a metal implant reduces operative time, time to union, and improves some functional measures; however, further clinical trials are necessary to support the findings of this study. Additionally, comparisons between metal implants and other biodegradable materials need to be conducted.
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
