Electrochemical versus plasma-coated femoral implant in total hip arthroplasty .
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by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(12):47 Acta Orthop. 2011 Feb;82(1):13-950 patients undergoing total hip arthroplasty were randomized to receive either plasma-sprayed hydroxyapatite (HA) or electrochemically deposited hydroxyapatite (Bonemaster, BM),as a coating for the fixation of uncemented femoral stems, in order to compare the safety and efficacy of the two coatings. At a follow-up of two years, the two groups were similar in regards to their clinical outcomes.
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
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?
Alternative bone coatings, such as Bonemaster (BM), provide potential advantages in terms of remodelling and transporting of bone-active substances. The trial was necessary to investigate whether the use of this alternative is safe for conventional clinical use.
Qual era a principal questão de investigação?
In patients undergoing total hip arthroplasty for non-inflammatory osteoarthritis, does electrochemically deposited Bonemaster provide non-inferior results in terms of safety, as compared with a conventional femoral implant utilizing plasma-sprayed hydroxyapatite?
- The null hypothesis was rejected for BMD in Gruen zone 1 (p = .01); bone loss was less in the BM group. The null hypothesis was accepted for all other regions (p > .05)
- No statistically significant results were obtained with respect to femoral migration or rotation following implantation (p > .05)
- There were no significant differences in the Harris Hip Scores at two year follow-up between the groups (p > .05)
- There were no significant differences in the oxford hip score between the two groups (p > .05)
De que é que me devo lembrar mais?
Functional scores, migration, and rotation of the femoral head following total hip arthroplasty were not significantly different. Potential benefits in terms of bone mineral density were identified in favor of the Bonemaster group.
Como é que isto afectará o tratamento dos meus doentes?
The results suggest that Bonemaster is clinically non-inferior to conventional plasma-sprayed hydroxyapatite and is a viable alternative. Long term follow-up is necessary to investigate other potential benefits of electrochemical deposition and whether or not long-term fixation is achieved. The small sample size of the study should be taken into account.
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