Similar treatment time and pain in tension-band plating vs stapling for hemiepiphysiodesis .
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(8):18 Acta Orthop. 2013 Apr;84(2):202-6. doi: 10.3109/17453674.2013.782526. Epub 2013 Mar 14The present trial evaluated 20 children with idiopathic genu valgum (IGV) who were randomized for hemiepiphysiodesis with either a tension band construct or staples to correct angular deformities. To compare the efficiency of both treatment methods, the time for correction of deformity, changes in angles as measured on radiographs, pain by visual analog scale (VAS) and analgesic consumption were recorded. The post-operative results indicated no differences between using staples and tension band plating for all outcomes.
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
3/4
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?
Hemiepiphysiodesis is used to correct excessive angular deformities in the extremities of children. Implants stop unilateral growth until the deformity is corrected and are then removed to resume growth. Staples have been used for this procedure, but are associated with complications such as staple migration, breakage, and premature growth plate closure. More recently, tension-band plating has been introduced for faster correction and prevention of growth plate compression. However, no known randomized trial has demonstrated superiority of tension-band plating technique over stapling.
Qual era la domanda di ricerca principale?
How do the clinical and radiographic effects of stapling compare to tension-band plating in children with IGV of the distal femur?
- The tension band group and staples group had similar time taken to correct idiopathic genu valgum deformity (mean 340 days (286–394) vs. mean 349 days (263–435), respectively) (p=0.8). Cohen’s delta showed an estimated effect size of 0.075.
- No implant failures, infection or growth arrests occurred, while all 20 children achieved correction of genu valgum deformity.
- Although groups differed in gender (M/F in staples group = 3/7 vs tension band = 8/2) and age (tension band group mean age = 10.1 ( 8–14 years) vs. staples group mean age = 11.1 (6–13) years), there were no differences in treatment time, preoperative intermalleolar distance, and measured radiographic values (LDFA, MPTA, and MAD) treatment (p>0.05).
- VAS pain was recorded for 18/20 children and was similar in both groups (p>0.05) 72 hours postoperatively.
- 1 child in tension-band group had a rebound of intermalliolar distance of 8 cm and was scheduled for surgery
Che cosa devo ricordare di più?
Hemiepiphysiodesis with both tension band and staples have similar treatment time and angle correction of idiopathic genu valgum.
Come influenzerà l'assistenza ai miei pazienti?
The trial was not able to show superiority of either hemiepiphysiodesis methods. Further studies with larger populations need to be conducted as this study may be underpowered.
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