Radiostereometric analysis: no additional benefit of Unique femoral stem compared to AGB-I .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(13):9 Acta Orthop. 2014 Apr;85(2):152-8100 patients with primary or secondary osteoarthritis were randomized to investigate any additional benefits associated with the use of the Unique customized stem compared with the conventional ABG-I stem. Patients were evaluated over 5 years using radiostereometric (RSA). The evidence presented in this study revealed no improvement in long-term mechanical stability associated with the Unique stem. It is important to note that no included patients presented with abnormal geometry of the upper femur for which the custom stems are developed.
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
Aleatorización
3/4
Medición de resultados
4/4
Inclusión / exclusión
4/4
Descripción de la terapia
3/4
Estadísticas
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?
Micromovements along the implant-bone interface are associated with loosening of uncemented femoral stem implants. Generally speaking, a 40 micrometer interfacial motion contributes to partial bone ingrowth, and those exceeding 150 micrometers completely disrupts ingrowth. Mechanical stability of the implant is influenced by patient- and implant-specific factors, and uncemented customized femoral stems are hypothesized to promote superior mechanical fixation compared to standard implants. This study was needed to conduct radiostereometric (RSA) follow-up on a 5 year RCT that evaluated the Unique customized stem (Scandinavian Customized Prosthesis [SCP]), against a conventional ABG-I stem.
Qual era la domanda di ricerca principale?
What is the comparative migration between the use of the Unique customized stem, and the conventional ABG-I stem, as evaluated using radiostereometric (RSA) over 5 years?
- Motion between the 2 types of stems were comparable (all p>0.05): The median subsidence was -0.03mm for the ABG-I stem compared to -0.13mm for the Unique stem (p=0.15). Mean retroversion was 0.15 degrees compared to -0.08 degrees in the ABG-I and Unique stems respectively (p=0.41).
- Time was noted as a factor that was significantly related to: translation along the y (p=0.02) and z (p<0.01) axes and rotation around the x (p=0.03) and z (p=0.01) axes.
- A single Unique stem subsided 5.3mm within the first year and then stabilized. Further analysis revealed no loosening.
- Mean preoperative Merle d’Aubigne score was 11 in the ABG-I group compared to 10 in the Unique groups. At final follow-up of 5 years, mean scores in both groups was 17.
- Preoperative pain decreased from 6.5 to 1.1 in the ABG-I group and from 6.5 to 1.0 in the Unique group. Satisfaction was 1.1 and 0.7 respectively at 5 years.
- No hips were revised over the 5 years; there were, however, 5 complications: ABG –I group had 2 instances of DVT and 2 early dislocations. The Unique group had 1 common peroneal nerve dysfunction.
Che cosa devo ricordare di più?
Radiostereometric analysis (RSA) between the use of the Unique customized stem ((Scandinavian Customized Prosthesis (SCP)), and the conventional ABG-I stem revealed no improvement in long-term mechanical stability associated with the Unique stem.
Come influenzerà l'assistenza ai miei pazienti?
The evidence presented in this study indicated no additional benefits associated with the use of the Unique customized stem ((Scandinavian Customized Prosthesis (SCP)). It is important to note that none of the included patients presented with abnormal geometry of the upper femur for which the custom stems were developed.
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