Tibial fractures: Alpha-BSM comparable to autogenous bone graft in preventing subsidence .
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original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(3):115 J Bone Joint Surg Am. 2008 Oct;90(10):2057-61119 patients presenting with acute, closed, unstable tibial plateau fractures (120 fractures) were randomized to undergo standard open reduction and internal fixation with either a bioresorbable calcium phosphate cement (alpha-BSM) or an autogenous iliac bone graft. The results after a 12 month follow-up indicated that the use of alpha-BSM was superior in reducing articular subsidence compared to autogenous iliac bone graft.
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.
3/4
Randomization
4/4
Outcome Measurements
2/4
Inclusion / Exclusion
3/4
Therapy Description
2/4
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?
For patients with defects resulting from unstable tibial plateau fractures, use of the autogenous iliac bone graft is considered the standard choice of treatment. However, there are reported disadvantages and complications associated with this procedure. Prevention of articular surface collapse is the primary goal of autogenous grafting to treat subarticular defects; however, the use of artificial material with internal fixation may provide the necessary benefits and support for the articular surface. Few in vivo studies have demonstrated the benefits of a calcium phosphate cement (alpha-BSM) over bone grafts indicating the need for more trials evaluating the effectiveness of the alpha-BSM.
Qual era a principal questão de investigação?
Is the use of a calcium phosphate cement (alpha-BSM) as effective as autogenous iliac bone graft in the treatment of subarticular bone defects resulting from tibial plateau fractures, measured over a 12 month time period?
- There was no significant difference regarding the age, height, weight, sex and fracture patterns of the patients between the two groups.
- There was no difference between the two treatment groups with respect to union or the frequency of union, and infections.
- There was no dissolution in either the bone graft of the alpha-BSM prior to fracture union, evidenced by the absence of radiolucent zones on radiographs. No patients in either of the treatment groups had loss of internal fixation.
- During the 3-12 month follow up period, the autogenous bone graft group had a significantly higher rate of articular subsidence compared to the alpha-BSM group (subsidence of 2mm or greater in 30% of autogenous graft patients vs. 9% of alpha-BSM patients) (p=0.009).
- The alpha-BSM group demonstrated a greater improvement in range of motion compared to the autogenous graft group (not significant difference).
De que é que me devo lembrar mais?
This study demonstrated that alpha-BSM, for the intervention of tibial plateau fractures, resulted in similar and possibly better mechanical support when compared to autogenous bone grafts, as less subsidence was observed in patients treated with alpha-BSM.
Como é que isto afectará o tratamento dos meus doentes?
Patients with unstable tibial plateau fractures may receive comparable outcomes when treated with alpha-BSM compared to autogenous iliac bone graft. As this is one of the first studies investigating alpha-BSM in comparison to autogenous iliac bone graft, further trials are need to establish alpha-BSM as an adequate augmentation to open reduction and internal fixation of unstable tibial plateau fractures.
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