Adult stem cells do not appear to accelerate graft-to-bone healing in ACL reconstruction .
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(8):38 Knee Surg Sports Traumatol Arthrosc. 2014 Jan;22(1):66-71. doi: 10.1007/s00167-012-2279-9. Epub 2012 Nov 2.43 patients undergoing anterior cruciate ligament (ACL) surgery using a hamstring graft were randomly assigned to a stem cell or a control group to evaluate the effect of stem cells on graft-to-bone healing. In the study, adult non-cultivated bone marrow stem cells were harvested from select patients and intra-operatively delivered in and around the femoral end of the graft. Upon analysis, the non-cultivated bone marrow stem cells did not appear to advance graft-to-bone healing in ACL reconstruction at 3 months post-operative.
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.
1/4
Randomization
4/4
Outcome Measurements
1/4
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?
In anterior cruciate ligament (ACL) reconstruction, healing of the tendon graft to the bone is crucial for a successful surgery. Recent research has explored the use of growth factors and stem cells to improve and enhance osteointegration of the graft within the bone tunnel, and avoid complications such as tendon pullout out, which can occur even up to a few months postoperatively. The aim of this study was to determine if non-cultivated adult bone marrow mesenchymal stem cells (BMSCs) could enhance tendon-to-bone healing in the femoral tunnel following ACL reconstruction using a hamstring graft.
¿Cuál era la pregunta principal de la investigación?
Are adult non-cultivated bone marrow stem cells able to accelerate tendon-to-bone healing in the femoral tunnel, measured approximately 3 months after ACL reconstruction?
- On PDW-FatSat images, there was no significant difference between the experimental vs. control group in median SNR of the upper interzone [12.3 (7.6-14.6) vs. 10.6 (8.7-13.1)] and lower interzone [10.4 (8.3-13.3) vs.12.4 (10.6-13.4)] (p>0.05).
- On T1W-FatSat-Gad images, there was no significant difference between the experimental vs. control group in median SNR of the upper interzone [22.3 (17.5-27.8) vs. 22.5 (18.8-31.0)] and lower interzone [21.8 (18.1-26.1) vs. 24.5 (21.1-33.5)] (p>0.05).
- A graft biopsy from one patient in each group revealed no apparent differences in collagen amount, vascularity, and number of cells between samples. Both patients were chosen for biopsies because they required second-look arthroscopy for meniscectomy at 4 months.
¿Qué es lo que más debo recordar?
From the results obtained in this study, graft-to-bone healing after ACL reconstruction does not appear to be expedited with the use of adjuvant adult non-cultivated bone marrow mesenchymal stem cells (BMSCs).
¿Cómo afectará esto al cuidado de mis pacientes?
While it appears stem cells do not accelerate graft to bone healing in ACL reconstruction, larger trials are required to confirm these results. Furhermore, it should be noted that MRI evaluation may not be sensitive enough to detect histological changes at the tendon-to-bone interface. Future studies are needed to further evaluate the efficacy of this augmentative therapy.
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