Metasul metal-on-metal THRs have high rate of revision and incidences of radiolucent lines .
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(16):1 Bone Joint J. 2013 Jul;95-B(7):881-6. doi: 10.1302/0301-620X.95B7.31067399 hips undergoing total hip replacement were randomized to receive either Metasul metal-on-metal (MoM), metal-on-conventional polyethylene (MoP), or ceramic-on-polyethylene (CoP) bearings using a cemented triple-tapered polished femoral component (MS-30). The study aimed to compare the three types of bearings in clinical and radiological outcomes. The results taken at 2,5,and 7 years revealed that MoM group had the lowest Harris Hips scores, higher rates of revision, and higher incidence of radiolucent lines in unrevised hips.
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.
3/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
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?
Metasul metal-on-metal (MoM) articulation has shown lower wear rates than metal-on-polyethylene (MoP) bearings in Total Hip Replacement (THR), especially when used in cementless fixation. However, some evidence has reported that cemented MoM articualtions using 28 mm bearing have high rates of radiolucent lines (RLLs) and aseptic loosening. Hence, this RCT aimed to compare cemented Metasul MOM bearing with MoP and ceramic-on-polyethylene (CoP) bearings.
¿Cuál era la pregunta principal de la investigación?
How do long term outcomes, such as incidences of radiolucent lines (RLLs), rate of revision, and clinical results, compare between cemented Metasul MoM, MoP, and ceramic-on-polyethylene (CoP) bearings used in total hip replacement?
- No difference was found in mean abduction angle (p=0.69) and HHS (p=0.104) at 7 years in 341 hips (86%) between the three bearing types.
- MoM hips had higher incidences of peri-acetabular radiolucent lines of greater and equal to 2mm (p<0.001),
- 12 revisions were performed, 8 in the MoM group, 3 in the MoP group and 1 in the CoP group. There was a significant difference in the number of revisions between the MoM and Mop/Cop groups (p<0.001).
- No aseptic loosening was seen in the MoP and CoP groups.
- 4infections occurred in the MoM group compared with 1 infection in the MoP group and 1 infection in the CoP group.
¿Qué es lo que más debo recordar?
The trial indicated that at a 7 year follow up period, cemented metal-on-metal bearings resulted in higher incidence of radioluscent lines around the acetabular component than metal-on-polyethylene and ceramic-on-polyethylene bearings. The metal-on-metal bearing also required higher revision rates and had lower Harris Hip scores.
¿Cómo afectará esto al cuidado de mis pacientes?
The study suggests that patients with 28 mm Metasul metal-on-metal bearing should be followed with caution when compared to the other implants used. It is unclear how these results may be applied to other metal on metal implants. Continuing surveillance of the outcomes of differing implant designs and bearing surfaces is warranted.
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