Factors predicting negative outcomes in intramedullary nailing of the tibia .
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Ciò consente di riconoscere prima le ricerche clinicamente significative e aiuta i lettori a concentrarsi sugli articoli che hanno maggiori probabilità di influenzare la pratica futura.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(6):117 J Bone Joint Surg Am. 2012 Oct 3;94(19):1786-93. doi: 10.2106/JBJS.J.01418.1226 patients who were included in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) and completed the 1 year follow-up were included in this study to identify prognostic factors for predicting negative outcomes of this treatment. Multivariable logistic regression analysis identified an increased risk of a negative event for high energy fractures, stainless steel nails vs titanium nails, fracture gaps, full postoperative weight bearing, and open fractures treated with reamed nailing from the 15 baseline and surgical factors investigated.
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
4/4
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 surgical fixation of tibial shaft fractures using intramedullary nail has become common practice, however, the choice between reamed and unreamed intramedullary nails has remained controversial. A recent study (SPRINT) investigated the outcomes of the use of reamed and unreamed intramedullary nails in the treatment tibial shaft fractures. Further assessments of baseline and surgical factors that may influence the risk of negative outcomes were needed to facilitate optimal patient care and guide treatment practices.
Qual era la domanda di ricerca principale?
Are there prognostic baseline or surgical factors associated with the risk of negative outcomes at 1 year following reamed or unreamed intramedullary nailing of open/ closed tibial shaft fractures?
- 1226 patients completed the one year follow-up and were used in the prognostic assessment. 622 patients were treated with reamed intramedullary nails and 604 patients were treated with unreamed intramedullary nails.
- There was an increased risk of negative outcomes in high-energy injuries compared to low energy injuries (OR=1.57 95CI, 1.05 to 2.35) (p=0.03), A similar increase in risk with evident with the use of stainless steel nails compared to titanium (OR-1.52 95CI 1.10 to 2.13) (p<0.01).
- A fracture gap of <1 cm compared to no fracture gap was also associated with a greater risk of negative outcomes (OR= 2.4 95CI, 1.47 to 3.94) (p<0.001), and finally full postoperative weight bearing compared to partial postoperative weight bearing was also associated with a greater risk of negative outcomes (OR=1.63 95CI 1.00 to 2.64) (p<0.048)
- The increased risk associated with full postoperative weight bearing and nail material was attributed to the autodynamization component of the composite score for negative outcomes. Autodynamization rate was 12.8 percent for full weight bearing versus 3.9 percent for partial/non-weight bearing. Autodynamization rate was 2.3 percent with titanium and 10.1 percent with stainless steel.
- Open fracture increased the risk of a negative outcome only for patients who had reamed nailing (OR=3.26 95CI 2.01 to 5.28). Patients who had primary closure or delayed primary closure had a decrease risk of an event compared to those requiring additional soft-tissue reconstruction. (OR=0.18; 95CI, 0.09 to 0.35, and OR= 0.29 CI 0.14 to 0.62 respectively)
- Reamed nailing had a decreased risk of negative outcomes than unreamed for patients with closed fractures (OR=0.60 95CI 0.40 to 0.92) (p=0.02). This relationship was no longer significant with the removal of autodynamization from the composite.
Che cosa devo ricordare di più?
The multivariable analysis identified a number of prognostic factors for negative events during the treatment of open and closed tibial shaft fractures. An increased risk of a negative event was found for high energy fractures, stainless steel nails vs titanium nails, fracture gaps, full postoperative weight bearing, and open fractures treated with reamed nailing.
Come influenzerà l'assistenza ai miei pazienti?
The findings from this study have identified a number of prognostic factors that may indicate an increased risk of a negative event during treatment of tibial fractures. The findings from this study can assist in identifying the best possible treatment option depending on the characteristics of the injury and instrumentation available.
DISCLAIMER
Il contenuto di questa pagina è solo a scopo informativo e non intende sostituire la consulenza, la diagnosi o il trattamento medico professionale. Se ha bisogno di cure mediche, si rivolga sempre al suo medico o al pronto soccorso più vicino. Le opinioni, le convinzioni e i punti di vista espressi dalle persone sui contenuti presenti in questa pagina non riflettono le opinioni, le convinzioni e i punti di vista di OrthoEvidence.
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