Unstable ankle fractures: Better clinical results with metal versus biodegradable implants .
تم تحديد هذه الدراسة على أنها ذات تأثير كبير محتمل.
يُقدّر مقياس التأثير العالي الذي يعتمد على الذكاء الاصطناعي من OE التأثير المحتمل لورقة بحثية ما من خلال دمج الإشارات من كل من المجلة التي نُشرت فيها والمحتوى العلمي للمقالة نفسها.
تم تطوير نموذج OE High Impact باستخدام أحدث تقنيات معالجة اللغة الطبيعية، ويتنبأ نموذج OE High Impact بدقة أكبر بأداء الاقتباس المستقبلي للدراسة أكثر من معامل تأثير المجلة وحده.
وهذا يتيح التعرف المبكر على الأبحاث ذات المغزى السريري ويساعد القراء على التركيز على المقالات التي من المرجح أن تشكل الممارسة المستقبلية.
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)?
نعم = 1
غير مؤكد = 0.5
غير ذي صلة = 0
لا = 0
يقيّم تقييم معايير الإبلاغ الشفافية التي يبلغ بها المؤلفون عن الخصائص المنهجية والتجريبية للتجربة في المنشور. ينقسم التقييم إلى خمس فئات معروضة أدناه.
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
مؤشر الهشاشة هو أداة تساعد في تفسير النتائج المهمة، وتوفر مقياسًا لقوة النتيجة. ويمثل مؤشر الهشاشة عدد الأحداث المتتالية التي يجب إضافتها إلى نتيجة ثنائية التفرع لجعل النتيجة غير مهمة. يمثل الرقم الصغير نتيجة أضعف ويمثل الرقم الكبير نتيجة أقوى.
لماذا كانت هناك حاجة لهذه الدراسة الآن؟
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.
ما هو سؤال البحث الرئيسي؟
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?
- 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.
ما الذي يجب أن أتذكره أكثر؟
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.
كيف سيؤثر ذلك على رعاية مرضاي؟
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.
تنويه
هذا المحتوى الموجود في هذه الصفحة هو لأغراض إعلامية فقط وليس الغرض منه أن يكون بديلاً عن المشورة الطبية المتخصصة أو التشخيص أو العلاج. إذا كنت بحاجة إلى علاج طبي، اطلب دائمًا مشورة طبيبك أو اذهب إلى أقرب قسم طوارئ إليك. الآراء والمعتقدات ووجهات النظر التي يعبر عنها الأفراد في المحتوى الموجود في هذه الصفحة لا تعكس آراء ومعتقدات ووجهات نظر أورثوإيفيدنس.
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