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)?
Oui = 1
Incertain = 0,5
Non pertinent = 0
Non = 0
L'évaluation des critères de rapport permet d'évaluer la transparence avec laquelle les auteurs rapportent les caractéristiques méthodologiques et les caractéristiques de l'essai dans la publication. L'évaluation est divisée en cinq catégories qui sont présentées ci-dessous.
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 de fragilité est un outil qui aide à l'interprétation des résultats significatifs, en fournissant une mesure de la force d'un résultat. L'indice de fragilité représente le nombre d'événements consécutifs qui doivent être ajoutés à un résultat dichotomique pour que le résultat ne soit plus significatif. Un petit nombre représente un résultat plus faible et un grand nombre un résultat plus fort.
Pourquoi cette étude était-elle nécessaire maintenant ?
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.
Quelle était la principale question de recherche ?
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?
Quels sont les résultats importants ?
- 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 quoi dois-je me souvenir en priorité ?
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.
Comment cela affectera-t-il les soins prodigués à mes patients ?
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.
AVIS DE NON-RESPONSABILITÉ
Le contenu de cette page est fourni à titre d'information uniquement et n'est pas destiné à remplacer un avis médical, un diagnostic ou un traitement professionnel. Si vous avez besoin d'un traitement médical, demandez toujours l'avis de votre médecin ou rendez-vous au service des urgences le plus proche. Les opinions, croyances et points de vue exprimés par les individus sur le contenu de cette page ne reflètent pas les opinions, croyances et points de vue d'OrthoEvidence.
0 de 4 articles mensuels GRATUITS débloqués
