SPORTS MEDICINE
Single-Bundle versus Double-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial with 6-Year Follow-up
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2022;10(10):43 J Knee Surg. 2017 Nov;30(9):898-90460 patients requiring anterior cruciate ligament (ACL) reconstruction were randomized to either double-bundle reconstruction or single-bundle reconstruction. Patients were assessed for instrumented anteroposterior knee laxity (KT-2000), subjective function, objective functional performance on hop tests, and osteoarthritis development over 6-year follow-up. Results demonstrated no significant differences in any outcome measure between the two groups. One case of rerupture was recorded, occurring in the DB reconstruction group.
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
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/5
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 prevalent comparison in research on outcomes following anterior cruciate ligament is single-bundle versus double-bundle reconstruction. More recently, emphasis has been placed on whether specific technical factors may influence if differences are found between groups or not.
主な研究課題は何ですか？
In anterior cruciate ligament reconstruction, does double-bundle reconstruction, using an independent tunnel drilling technique, provide significantly greater anteroposterior knee stability compared to single-bundle reconstruction, using a transtibial technique, assessed over 6-year follow-up?
重要な知見は？
- At final follow-up, there was no significant difference in side-to-side difference KT-2000 results between the DB group (1.4+/-0.6mm) and the SB group (1.3+/-0.8mm) (p=0.74).
- At final follow-up, there was no significant difference in Lysholm score between the DB group (96.4+/-17.3) and the SB group (94.2+/-15.3) (p=0.36).
- At final follow-up, there was no significant difference in IKDC score between the DB group and the SB group (p=0.23).
- At final follow-up, there were no significant differences between the DB group and the SB group in single hop distance (p=0.1528), crossover top distance (p=0.14) and the timed hop test (p=0.16).
- There was one case of rerupture (DB group).
- Medial compartment OA development was observed in 3 patients of the DB group and 2 patients of the SB group.
最も覚えておくべきことは？
In ACL reconstruction, there was no significant difference in 6-year AP stability, subjective functional outcome, or objective functional performance between cases completed using double-bundle, independent tunnel drilling reconstruction and cases completed using single-bundle, transtibial drilling reconstruction.
それが私の患者ケアにどのように影響するか？
Mid-term follow-up to 6-year data appears to suggest that outcomes may be similar for double-bundle ACL reconstruction and single-bundle ACL reconstruction. There does not appear to be significant differences in subjective or objective function, AP stability, or OA development between the two techniques. Nonetheless, this study is one of only a few randomized trials to extend follow-up beyond 5 years in a comparison between double- and single-bundle reconstruction. Accordingly, additional data is needed to verify if there are indeed any differences in outcome between the two techniques.
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