Higher AP laxity with irradiated versus non-irradiated hamstring allograft in DB ACL reconstruction .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2018;6(9):16 Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):251-259112 patients scheduled for unilateral anterior cruciate ligament reconstruction were randomized to have the procedure completed using either a gamma-irradiated hamstring allograft or a non-irradiated hamstring allograft. Patients were assessed over a 5-year follow-up after surgery. Findings demonstrated significantly poorer results for instrumented knee laxity and subjective knee stability tests at 5 years in the irradiated allograft group compared to the non-irradiated allograft group. However, there were no differences in functional and activity 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)?
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?
A tear of the anterior cruciate ligament (ACL) is a common sporting injury. Arthroscopic reconstruction of the ACL is often undergone in those who wish to restore knee stability and return to athletic activities. Though traditionally completed using autogenic tissue sources, there has been a recent increase in the use of allografts in ACL reconstruction. Irradiation remains a common method of graft sterilization, though concerns have been expressed about the potential negative impact of gamma irradiation on mechanical properties of the graft.
¿Cuál era la pregunta principal de la investigación?
In double-bundle ACL reconstruction, do gamma-irradiated hamstring tendon allografts result in significantly worse knee stability and clinical scores when compared to non-irradiated hamstring tendon allografts, assessed over a minimum of 5-year follow-up?
- Mean instrumented anteroposterior knee laxity at final follow-up was significantly higher in the Ir-Allo group (9.0+/-1.1mm) compared to the Non-Ir-Allo group (5.3+/-1.0mm) (p=0.000).
- The percentage of patients demonstrating side-to-side difference in instrumented AP knee laxity of <3mm was significantly lower in the Ir-Allo group (14/39) compared to the Non-Ir-Allo group (38/44) (p=0.000).
- The percentage of patients demonstrating side-to-side difference in instrumented AP knee laxity of >5mm was significantly higher in the Ir-Allo group (12/39) compared to the Non-Ir-Allo group (4/44) (p=0.000).
- Significant differences between groups at final follow-up were observed for grading of the pivot-shift test (p=0.001), anterior draw test (p=0.000), and Lachman test (p=0.000), with fewer patients in the Ir-Allo group demonstrating negative tests for each when compared to the Non-Ir-Allo group.
- No significant differences in functional outcomes (Overall IKDC, knee ROM, vertical jump, one-legged hop) were observed between groups at final follow-up.
- No significant differences in patient-reported outcome measures (IKDC subjective, Cincinnati knee score, Lysholm, Tegner) were observed between groups at final follow-up.
¿Qué es lo que más debo recordar?
In anatomic double-bundle ACL reconstruction with a hamstring allograft, irradiated allografts demonstrated significantly greater knee instability and laxity, including instrumented AP translation and subjective grading using the Lachman, anterior drawer, and pivot shift test, when compared to non-irradiated allografts over a minimum of 5-year follow-up. However, despite significant differences in measured mechanical outcomes, there was still no difference in clinical outcomes.
¿Cómo afectará esto al cuidado de mis pacientes?
The results of this study suggest that irradiation of hamstring tendon allografts for use in double-bundle ACL reconstruction may result in poorer mid-term knee laxity and stability, and may result in a higher rate of clinical failure when considering thresholds of anteroposterior side-to-side differences in translation. Despite the lack of significant difference in overall functional outcome in the mid-term between irradiated and non-irradiated hamstring tendon allografts, the data on knee stability from the current study appear to identify non-irradiated hamstring tendon allografts as the potential better choice for graft in anatomic double-bundle ACL reconstruction.
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