Muller vs. Virtec straight stem shape comparable for long-term radiological change in THR .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(12):16 Acta Orthop. 2016 Apr;87(2):120-5.646 patients (711 hips) patients undergoing primary total hip replacement with straight femoral stem cement fixation were randomized to receive either a Muller straight stem (MSS) or the Virtec straight stem (VSS) for the purpose of comparing long-term radiographical and survival success ten years post-surgery. Results demonstrated that patients in both groups had comparable implant survival, osteolysis, subsidence, and debonding rates at 10 years.
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)?
Sí = 1
Incierto = 0,5
No relevante = 0
No = 0
La evaluación de los criterios de información evalúa la transparencia con la que los autores informan de las características metodológicas y del ensayo dentro de la publicación. La evaluación se divide en cinco categorías que se presentan a continuación.
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Randomization
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Outcome Measurements
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Inclusion / Exclusion
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Therapy Description
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Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
El Índice de Fragilidad es una herramienta que ayuda en la interpretación de hallazgos significativos, proporcionando una medida de fuerza para un resultado. El Índice de Fragilidad representa el número de eventos consecutivos que es necesario añadir a un resultado dicotómico para que el hallazgo deje de ser significativo. Un número pequeño representa un hallazgo más débil y un número grande un hallazgo más fuerte.
¿Por qué se necesitaba ahora este estudio?
There are two major femoral stem fixation methods that are regularly used in total hip replacement: shape-closed or force-closed stems. In shape-closed fixation, stems are surrounded by a thin cement mantle and are enhanced with an additional press-fit fixation against the cortical bone. Furthermore, shape-closed fixation can use varying stem shapes, including the Muller straight stem (which has a rectangular cross section) and the Virtec straight stem (which has a wider cross section with rounder edges). Due to the lack of conclusive evidence supporting a significant long-term benefit of one stem shape over the other, the current study was conducted.
¿Cuál era la pregunta principal de la investigación?
For patients undergoing cemented shape-closed fixation during total hip replacement, did either the Muller straight stem (MSS) or the Virtec straight stem (VSS) result in significant radiographical improvement in osteolysis, radiolucency, and distal migration when compared at least ten years post-surgery?
- When compared at 10 years, Kaplan-Meier (KM) survival after "revision of component for any reason" was observed to be 92% (95% CI 88-95) in the MSS group and 95% (95% CI 92-97) in the VSS group; the difference was not significant (p=0.1)
- KM survival after revision for "aseptic loosening of the stem", specifically was 96% (95% CK 94-99) in the MSS group and 98% (95% CI 97-100) in the VSS group; the difference was also not significant (p=0.2).
- 399 hips (196 in the MSS group and 203 in the VSS group) were radiologically assessed at a mean follow-up of 11 (10 to 16) years for unrevised hips and 6.85 (1 to 16) years for revised hips.
- In the stems that were revised for aseptic loosening (n=22), 17 of them displayed radiological osteolysis on the final radiograph before revision; osteolysis was found to be more common in the MSS groups in Gruen zones 2, 6, and 7 (p=0.06, p=0.07, and p=0.04 respectively).
- Subsidence was found in 5 MSS stems and 4 VSS stems; debonding at the cement-prosthesis interface was found in 6 MSS stems and 4 VSS stems (all 10 cases of debonding were observed in Gruen zone 1).
¿Qué es lo que más debo recordar?
For patients undergoing cemented shape-closed fixation during total hip replacement, both the Muller straight stem (MSS) and the Virtec straight stem (VSS) resulted in adequate long-term survival with minimal aseptic loosening, incidence of osteolysis, subsidence and debonding.
¿Cómo afectará esto al cuidado de mis pacientes?
The results of this study suggest that Muller and Virtec stems offer excellent survival over a 10 year period. Further randomized trials should be undertaken to evaluate the effect of stem geometry on radiographic changes and survival in different implants.
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