Unstable ankle fractures: Better clinical results with metal versus biodegradable implants .
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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)?
Sim = 1
Incerto = 0,5
Não relevante = 0
Não = 0
A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.
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
O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.
Porque é que este estudo era necessário agora?
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.
Qual era a principal questão de investigação?
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.
De que é que me devo lembrar mais?
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.
Como é que isto afectará o tratamento dos meus doentes?
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.
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