Tibial components for primary knee osteoarthritis .
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):108 Acta Orthop. 2011 Apr;82(2):177-86.50 patients were randomized to receive either high-porosity trabecular metal (TM) tibial components or low-porosity titanium pegged porous fiber-metal (Ti) components in the treatment of primary osteoarthritis of the knee. This study was performed to compare the stability of these cementless implants. The results indicated that TM tibial components migrated less than the Ti components at 1 and 2 year post-surgery follow-ups.
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.
3/4
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?
There is currently insufficient evidence regarding the efficacy of high-porosity double-pegged trabecular metal versus low-porosity titanium pegged fiber-metal as a cementless tibial component for patients suffering from primary knee osteoarthritis.
Qual era la domanda di ricerca principale?
Does a high-porosity double-pegged trabecular metal component tibial lead to improved fixation as compared to a low-porosity titanium fiber-metal tibial component in patients undergoing intervention for primary knee osteoarthritis, when measured two years post-operatively?
- Migration of the trabecular (TM) component was significantly less than the low-porosity titanium component. This result was significant at both the one year (p = .01) and two year follow-up (p = .004).
- AKSS reports of both groups indicated reductions in pain at 2 year follow-up compared to preoperative scores, with 14/22 in the TI group and 17/23 in the TM group, reporting no pain.
Che cosa devo ricordare di più?
The trabecular metal component was superior to the low-porosity titanium component in terms of total migration, measured two years postoperatively.
Come influenzerà l'assistenza ai miei pazienti?
This study provides support for the use of porous tantalum as an alternative to traditional implants. However, the small sample size of the study and the unknown results of longer term follow up should be considered.
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