Risedronate following total hip arthroplasty does not prevent periprosthetic bone loss .
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original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(2):4 Acta Orthop. 2015 Oct;86(5):569-7474 patients scheduled for uncemented total hip arthroplasty were randomized to postoperative administration of either risedronate or placebo for 6 months. The purpose of this study was to compare changes in periprosthetic bone mineral density between groups at 4 year follow-up. Additionally, component migration, the incidence of heterotopic ossification, and clinical outcomes were assessed during follow-up. Results demonstrated no significant difference in periprosthetic BMD changes between groups after 4 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?
Periprosthetic bone mass loss following total hip arthroplasty remains an important concern, given its implications in possible periprosthetic fracture and component loosening. Much research has been conducted on the efficacy of risedronate, a bisphosphonate, in the attenuation of bone loss in patients with osteoporosis, and research has started to be conducted in its possible role as a postoperative therapy following total joint arthroplasty. Nevertheless, the body of evidence is still too small to establish the role of risedronate therapy following total hip arthroplasty.
¿Cuál era la pregunta principal de la investigación?
Following total hip arthroplasty, what effect does risedronate therapy have on periprosthetic bone resorption, as compared to placebo over 4 year follow-up?
- Mean decrease in BMD of Gruen zones 1 and 7 after 4 years did not significantly differ between groups. In Gruen zone 1, the mean decrease in BMD was -19% (+/-14) in the risedronate group and -21% (+/-13) in the placebo group (p=1.0). In Gruen zone 7, decreases were -23% (+/-16) and -22% (+/-15%), respectively (p=1.0).
- There were also no significant between-group differences in percent change in BMD of Gruen zones 2-6 after 4 years (all p>0.05).
- Groups demonstrated a similar degree of subsidence of the femoral stem after 4 years; -1.7mm (+/-1.2) in the risedronate group and -1.7mm (+/-1.5) in the placebo group.
- Incidence of heterotopic ossification was similar between groups; 10 patients of the risedronate group (8 Class I-II; 2 Class III-IV) and 8 patients in the placebo group (7 Class I-II; 1 Class III-IV).
- Clinical outcome measures of the Harris Hip Score and EQ-5D were similar between groups at 4-year follow-up.
¿Qué es lo que más debo recordar?
Postoperative administration of risedronate for 6 months after total hip arthroplasty was not met with a significant effect on perioprosthetic bone mineral density at 4-year follow-up, as compared to placebo.
¿Cómo afectará esto al cuidado de mis pacientes?
The results of this study suggest that risedronate is not effective for long-term attenuation of periprosthetic bone mineral density following total hip arthroplasty. Additional, high-quality randomized controlled trials are needed to confirm the current findings, and evaluate if there is role of risedronate in the postoperative management of patients following total hip arthroplasty.
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