ARTHROPLASTY
Local peroperative treatment with a bisphosphonate improves the fixation of total knee prostheses: A randomized, double-blind radiostereometric study of 50 patients
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):96 Acta Orthop. 2007 Dec;78(6):795-950 patients scheduled to receive a cemented knee prosthesis were randomized to receive either a localized treatment of ibandronate (a type of bisphosphonate) or a saline solution placebo during surgery. The primary outcome was maximal total point motion (MTPM) measured by radiostereometry (RSA). Results indicated that ibandronate appears to be a safe and viable treatment in reducing risk of prosthesis migration.
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
4/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
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?
An optimal balance of bone resorption and formation is required for better early fixation in knee prostheses. Bisphosphonates impair bone resorption, leading to a more positive balance for early implant fixation. A previous study by the same authors have indicated the effectiveness of a bisphosphonate (an oral treatment of clodronate) in reducing migration rates of knee prostheses.This study examines the outcomes in total knee prosthesis fixation when ibandronate is locally administered peroperatively during surgery.
Qual era a principal questão de investigação?
What are the outcomes in maximal total point motion (MTPM) at 24 months when ibandronate is locally administered peroperatively in patients undergoing total knee prosthesis surgery?
Quais foram os resultados importantes?
- The ibandronate group had reduced migration and had a reduction rate of 0.45 to 0.32 mm (95%CI for reduction: 0.04-0.21 mm) at 6 months. (p=0.006)
- Migration along the y-axis was influenced significantly in patients who received Ibandoronate prior to surgery (p=0.009)
- There was a reduction in migration from the postoperative examination of 0.47 to 0.36 mm (95% CI for reduction: 0.02-0.20 mm) at 12 months.
- There was a reduction in migration from the postoperative examination of 0.47 to 0.40 mm (95%CI: -0.01-0.16 mm) at 24 months.
De que é que me devo lembrar mais?
The locally administered ibandronate treatment appears to be a safe and effective treatment in reducing the risk of prosthesis migration during knee prosthesis fixation surgery.
Como é que isto afectará o tratamento dos meus doentes?
Patients may find improved stability and reduced migration when ibandronate is locally administered peroperatively during knee prosthesis fixation surgery. Further research on this study with a larger sample size is needed to verify the results presented in this study.
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