Trabecular metal cementless implants lead to improved knee scores following TKA .
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(3):4 Clin Orthop Relat Res. 2013 Nov;471(11):3543-53145 patients, between the ages of 50 and 70 years, who were admitted for primary TKA and who had moderate to severe femorotibial gonarthrosis were randomly assigned into 1 of 2 groups to compare the efficacy of a tibial component fixed by a porous tantalum system to a conventional cemented implant in terms of clinical outcomes, complications/reoperations, and radiographic results. The findings of the study indicate that at the 5 year follow-up mean KSS and mean WOMAC scores were significantly better in the cementless group when compared to the cemented group. However, no differences in frequency of complications or aseptic loosening between the two groups were found.
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.
4/4
Aleatorización
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Medición de resultados
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Inclusión / exclusión
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Descripción de la terapia
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Estadísticas
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?
TKA has become a widely accepted procedure for reducing pain and improving function in patients who are experiencing physical limitations of the knee/leg. Currently, cemented TKA is the accepted standard for TKA consistently providing predictable and durable results, but certain restrictions/limitations with this procedure have led to further development of alternative techniques. Cementless fixation seeks to address the common issue of aseptic failure in patients with cemented fixation (especially in younger individuals), and increased durable biological fixation with more physiologic transfer of stress to the underlying bone. Early results with cementless implants showed promising results with achieving these goals, but a wide variety of complications and failures occurred. Tantalum, a newer biomaterial that mimics cancellous bone, may be able to overcome the issues that occurred with previous cementless implants.
Qual era a principal questão de investigação?
Does a tibial component fixed by a porous tantalum system achieve better clinical outcomes, fewer complications/reoperations, and improved radiographic results when compared to a conventional cemented implant?
- Patients who received Cementless tibia implants exhibited improved KSS and WOMAC scores when compared to those who received the cemented implants.
- At 5 year follow up mean KSS score was 90.4 in Group 1 and 86.5 in Group 2, a significant difference in favour of the Cementless group (p=0.02). Effect size at 95% CI for difference between the means was 3.88 +/- 2.87.
- At 5 year follow up the WOMAC mean was 15.1 in Group 1 and 19.1 in Group 2, a significant difference in favour of the Cementless implant group (p=0.02). Effect size at 95% CI for difference between the means was -4.0 +/- 3.9.
- Average KSS and WOMAC scores reported at 6 months and 5 years post operatively were significantly improved from preoperative levels in both groups (p<0.001 at both follow ups for both outcomes)
- No differences between groups in terms of frequency of complications or reoperations were found by final follow up. In total 10% of Group 1 patients and 14% of Group 2 patients underwent additional procedures for complications, most of which were manipulations under anesthesia.
- Radiographic analysis showed no difference in radiologic alignment at 5 years between the groups, and no changes in component position or osteolysis were found during the follow up period. Two patients in group 1 had progressive radiolucent lines under the anterior flange of their femoral component, but zero patients (in either group) experienced progressive radiolucent lines around the tibial component or aseptic loosening.
De que é que me devo lembrar mais?
At 5 year follow up KSS mean and mean WOMAC scores were significantly better in the cementless group when compared to the cemented group. There were no differences in frequency of complications or aseptic loosening between the two groups.
Como é que isto afectará o tratamento dos meus doentes?
The results of the study suggest that there are statistically significant differences between uncemented porous tantalum tibial components and conventional cemented tibial components in terms of knee function score, in favour of uncemented treatment. Further research determining if the difference in results outweighs the cost increase of the cementless treatment is needed.
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