SPORTS MEDICINE
The Effect of Graft Tissue on Anterior Cruciate Ligament Outcomes: A Multicenter, Prospective, Randomized Controlled Trial Comparing Autograft Hamstrings With Fresh-Frozen Anterior Tibialis Allograft
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):222 Arthroscopy. 2012 Aug;28(8):1079-86. doi: 10.1016/j.arthro.2012.05.010147 patients undergoing anterior cruciate ligament (ACL) reconstruction were randomized to receive surgery with autogenous hamstring tendon or with fresh-frozen allograft anterior tibialis tendon. Over 2 years, there was no difference between the two groups with regard to stability, pivot shift test results, radiographic outcomes, International Knee Documentation Committee (IKDC) subjective and functional scores, and complications.
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。
4/4
Randomização
3/4
Medidas de resultado
2/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
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？
Although research has shown excellent results with regard to the use of autografts in ACL reconstruction, some surgeons prefer to use allografts in order to prevent the occurrence of harvest site morbidity. There is little high quality research investigating the effectiveness of allografts, in that most studies have been retrospective in nature. From this research, it has been determined that rejection and slow recovery are potential problems in patients who receive allografts. This study aimed to compare the use of an autogenous hamstring tendon with a fresh-frozen allograft anterior tibialis tendon in ACL reconstruction in order to determine if there is a difference between the two treatments with regard to stability and functioning.
主な研究課題は何ですか？
Is there a difference between the use of autogenous hamstring tendon and fresh-frozen anterior tibialis tendon allograft in ACL reconstruction with regard to clinical outcomes and knee stability assessed over 2 years?
重要な知見は？
- At 2 years, there was no significant difference between the two groups for the maximum manual KT scores (autograft: 85% with normal stability, allograft: 90% with normal stability; p>0.05)
- The two groups did not differ with respect to mean IKDC subjective scores (91.0, 90.9; p>0.05) and mean functional IKDC scores (85% normal, 90% normal; p>0.05) at 2 years
- There was no significant difference between the two groups at 2 years for the pivot-shift test results (89% with normal findings, 92% with normal findings; p>0.05), the number of patients with effusion (1 in the autograft group and 0 in the allograft group; p>0.05), knee extension (94% with normal extension, 96% with normal extension; p>0.05), thigh circumference (p>0.05), and the single leg hop test results (p>0.05)
- According to radiographs, 93% of the autograft group and 88% of the allograft group had no evidence of medial compartment arthrosis (p>0.05). 96% of the autograft group and 88% of the allograft group demonstrated no evidence of lateral compartment arthrosis.
最も覚えておくべきことは？
Results suggest that there is no difference between the use of a hamstring autograft and the use of a fresh-frozen soft-tissue tibialis allograft in ACL reconstruction with regard to clinical outcomes, function, knee stability, and radiographic outcomes at 2 years.
それが私の患者ケアにどのように影響するか？
Further research with appropriate sample sizes, greater follow up, and patient-centered clinical outcomes is needed to compare the effectiveness of autografts and allografts in ACL reconstruction.
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