THA: Less transverse rotation of tantalum trabecular metal acetabular cup .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):18 Acta Orthop. 2011 Apr;82(2):155-60. Epub 2011 Mar 2560 patients with noninflammatory hip arthritis were randomized to receive either a tantalum trabecular metal acetabular cup or titanium fiber-mesh cup, as part of the primary hip arthroplasty surgical procedure. The primary endpoint was cup migration. Bone mineral density and the Harris hip score were also evaluated. Results indicated positive early results with the tantalum trabecular metal cup on fixation outcomes, as well as comparable results on the secondary endpoint outcomes. A longer observation period is recommended to examine the effects over a longer time period.
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
Randomization
3/4
Outcome Measurements
3/4
Inclusion / Exclusion
2/4
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?
Initial stability is critical for an implant to achieve bone ingrowth. A number of clinical studies have shown good outcomes in bone ingrowth with trabecular metal. However, no published studies have examined this relationship with radiostereometric analysis (RSA). This study compares tantalum trabecular metal acetabular cups and titanium fiber-mesh cups in primary hip arthroplasty.
Qual era a principal questão de investigação?
What are the outcomes in cup migration, bone mineral density, and Harris hip scores with tantalum trabecular metal acetabular cups compared to titanium fibermesh cups, in patients with noninflammatory hip arthritis undergoing primary hip arthroplasty at 2 years?
- Radiostereometric analysis (RSA) indicated minimal rotation and translation at the 2-year follow-up. No statistically significant difference was seen between the two groups on translation. The trabecular tantalum surface cups (Monoblock) had less rotation on the transverse axis compared to the titanium fiber-mesh cup (Trilogy) (Monoblock: Mean -0.01 degrees [95%CI: -0.11 to 0.12]; Trilogy: Mean -0.60 degrees [95%CI: -0.72 to -0.48]) (p=0.04)
- Both groups reported a similar increase in Harris hip score at 3 months postoperatively from a score of 50 (28-70) to 92 (76-100) in the tantalum group and from 48 (34-64) to 95 (77-100) in the Trilogy group
- Both groups had similar degrees of reduction in bone mineral density
De que é que me devo lembrar mais?
Positive early results were seen for both implant cups in terms of fixation onto the acetabular host bone. RSA revealed both groups had minimal rotation and translation (with less rotation on the transverse axis for the tantalum group). Results also indicated similar reduction in bone mineral density and similar increase in Harris hip score.
Como é que isto afectará o tratamento dos meus doentes?
A study with a longer observation period is recommended to determine the long-term outcomes of the tantalum trabecular metal acetabular cups.
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