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Factors predicting negative outcomes in intramedullary nailing of the tibia
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TRAUMA

Prognostic factors for predicting outcomes after intramedullary nailing of the tibia
High Impact
Este estudo foi identificado como tendo um impacto potencialmente elevado. A métrica de Alto Impacto da OE, baseada em IA, estima a influência que um artigo poderá ter, integrando sinais da revista em que foi publicado e do conteúdo científico do próprio artigo. Desenvolvido com recurso ao mais avançado processamento de linguagem natural, o modelo High Impact da OE prevê com maior precisão o desempenho futuro de um estudo em termos de citações do que o fator de impacto da revista por si só. Isto permite o reconhecimento precoce de investigação clinicamente significativa e ajuda os leitores a concentrarem-se nos artigos com maior probabilidade de moldar a prática 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.


Detalhes do financiamento da publicação +
Financiamento:
Industry funded
Patrocinador:
Zimmer: Non-Industry Funded: CIHR; NIH; Orthopaedic Research & Education Foundation of the AAOS; OTA; HHS Research Grant; Canada Research Chair in Musculoskeletal Trauma at McMaster University
Conflitos:
None disclosed

Risco de viés

8/10

Critérios de notificação

19/20

Índice de Fragilidade

N/A

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)?

Sim = 1

Incerto = 0,5

Não relevante = 0

Não = 0

A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.

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

O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.

Porque é que este estudo era necessário agora?

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 a principal questão de investigação?

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?

Caraterísticas do estudo +
População:
1339 patients with open or closed tibial shaft fracture (Tscherne Type 0 to 3 and Gustilo-Anderson Type I to IIIB) that was amenable with surgical repair.
Intervenção:
Reamed Intramedullary Nail: Patients underwent surgical treatment receiving a reamed intramedullary nail (n=678).
Comparação:
Unreamed Intramedullary Nail: Patients underwent surgical treatment receiving an unreamed intramedullary nail (n=661).
Resultados:
Assessment of 15 baseline and surgical factors associated with the risk of negative outcomes. Negative outcomes were defined as a composite outcome which included; bone-grafting, implant exchange, dynamization in patients with a fracture gap of <1 cm, and infection/fasciotomy irrespective of fracture gap. Assessment was done using multi-variable logistic regression. Factors included in the analysis were; age, mechanism of injury, smoking status, NSAID use, Isolate vs additional injury, AO/OTA fracture classification, Location, Open vs Closed, reamed vs unreamed, Nail material, number of locking screws, Fracture gap, time from injury to treatment, postoperative weight bearing status and type of coverage.
Métodos:
RCT: double blind: Prognostic level II study.
Tempo:
1 year.

Quais foram os resultados importantes?

  • 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.
De que é que me devo lembrar mais?

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.

Como é que isto afectará o tratamento dos meus doentes?

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.

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OrthoEvidence. Factors predicting negative outcomes in intramedullary nailing of the tibia. OE Journal. 2013;1(6):117. Available from: https://myorthoevidence.com/AceReport/Show/factors-predicting-negative-outcomes-in-intramedullary-nailing-of-the-tibia

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