Coatings for femoral stems .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):23 Acta Orthop. 2011 Jun;82(3):308-14. Epub 2011 Apr 1950 arthritic patients undergoing total hip arthroplasty were randomized to receive either distally tapered, extended coated stems, or straight proximally coated stems, to study potential differences in implant migration. At 2 years post-surgery, radiostereometric analysis revealed that both stem types demonstrated large amounts of implant migration, with no significant differences between groups.
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
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
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?
The varying types of femoral stem coatings used for total hip arthroplasty have been investigated in studies to determine implant migration and rotation. This study aims to further investigate the outcomes with respect to extended coating versus proximal coating.
Qual era la domanda di ricerca principale?
Does an extended coated stem lead to reduced implant migration two years postoperatively, when compared to a proximally coated stem in patients undergoing total hip arthroplasty for primary osteoarthritis?
- no statistically significant difference during RSA assessment with respect to rotation or translation detected between groups at any of the follow-up points
- implant migration of both groups was significant from initial postoperative measurements
Che cosa devo ricordare di più?
Both implant stem groups demonstrated significant migration in comparison to baseline measures; however, no statistically significant difference was detected between the groups. The authors recommend that additional follow-ups are required in future trials.
Come influenzerà l'assistenza ai miei pazienti?
Both implants demonstrate significant migration,which warrants further investigation; however, this trial was unable to conclude which coating is superior. Additionally, the authors cite this study as an evidence for the necessity of RSA, as standard protocol to monitor all new implants.
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