SPORTS MEDICINE
Arthroscopic anatomic double-bundle ACL reconstruction using irradiated versus non-irradiated hamstring tendon allograft
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)?
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。
2/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
3/4
Therapy Description
4/4
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？
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.
主な研究課題は何ですか？
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?
重要な知見は？
- 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.
最も覚えておくべきことは？
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.
それが私の患者ケアにどのように影響するか？
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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