SPORTS MEDICINE
Is there a role for adult non-cultivated bone marrow stem cells 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)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
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
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
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.
主な研究課題は何ですか？
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?
重要な知見は？
- 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.
最も覚えておくべきことは？
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).
それが私の患者ケアにどのように影響するか？
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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