Local peroperative treatment of bisphosphonate improves knee prosthesis fixation .
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)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
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
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
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 la domanda di ricerca principale?
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?
- 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.
Che cosa devo ricordare di più?
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.
Come influenzerà l'assistenza ai miei pazienti?
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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