No significant difference in 10-yr migration between high & low viscosity cement in THA .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2017;5(3):1 Acta Orthop. 2016 Oct;87(5):473-839 patients scheduled for cemented total hip arthroplasty were randomized to receive either low viscosity bone cement or high viscosity bone cement. The purpose of this study was to compare femoral component migration via radiostereometric analysis (RSA) over a 10-year follow-up. The results of this study demonstrated no significant differences between groups in femoral component translation or rotation over the follow-up.
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
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
2/4
Therapy Description
3/4
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?
Aseptic loosening of components in cemented total hip arthroplasty is the most common reason for revision and has been suggested to be predicted by early, short-term migration. High and medium viscosity bone cement have traditionally been used, with low viscosity bone cement more recently introduced. It is unknown if early migration, and ultimately revision rates, significantly differ between high and low viscosity bone cement.
Qual era a principal questão de investigação?
In cemented total hip arthroplasty, is there any significant difference in radiostereometric analysis of component migration between components fixed with low viscosity bone cement (Palamed) versus high viscosity bone cement (Palacos) over a 10-year follow-up?
- Only 12 patients were available for the 10-year follow-up.
- No significant difference between groups in mediolateral, craniocaudal, or anteroposterior translation of the femoral component was observed over 10-year follow-up (p=0.5, 0.4, and 0.9, respectively).
- Maximum total point motion also did not significantly differ between the Palamed group (1.3mm [95%CI 0.88-1.8]) and the Palacos group (1.3mm [95%CI 0.56-2.1]) after 10 years (p=0.7).
- No significant difference between groups in mediolateral, craniocaudal, or anteroposterior rotation of the femoral component was observed over 10-year follow-up (p=0.6, 0.9, and 0.6, respectively).
- There were no differences in the Harris Hip Score at any time point between the two groups.
De que é que me devo lembrar mais?
In cemented total hip arthroplasty, there was no significant difference in femoral prosthesis migration after 10 years between components fixed with a low viscosity bone cement (Palamed) and components fixed with a high viscosity bone cement (Palacos).
Como é que isto afectará o tratamento dos meus doentes?
The results of this study suggest that low viscosity Palamed bone cement and high viscosity Palacos cement demonstrate similar long-term stability of the femoral component in cemented total hip arthroplasty. The similar results observed with these two types of cement suggest that decisions regarding the cement used should be left to the discretion of the surgeon. However, it should be noted that the limited number of patients still available at the 10-year follow-up limited the ability to detect significant differences.
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