TRAUMA
Reduction of tunnel enlargement with use of autologous ruptured tissue in anterior cruciate ligament reconstruction: a pilot clinical trial
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(11):40 Arthroscopy. 2014 Apr;30(4):468-74. doi: 10.1016/j.arthro.2013.12.014.10 patients with ACL deficiencies were randomized to undergo double-bundle ACLR with either autologous ruptured ACL tissue sutured to grafts or conventional grafts, to compare magnitude of tunnel enlargement and clinical outcomes. Results indicated a significant decrease in femoral tunnel enlargement between groups, favouring the ruptured tissue group. Tibial tunnel enlargement ratios were similar between groups. Clinical outcomes were also not significantly different between groups.
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
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？
Recent developments in anterior cruciate reconstruction have focused on achieving anatomic reduction of the AM and PL bundles with hamstring grafts. However, while patients enjoy favourable outcomes, treatment can lead to significant tunnel enlargement and complicate ACL revision surgeries in the long-term. Recently, researchers have observed properties of tendon-bone healing in ruptured ACL tissue (i.e. CD34+ cells). Applications in animal studies have demonstrated a capacity for healing and ability to reduce magnitude of tunnel widening. This study aimed to pilot a technique that utilizes autologous rupture ACL tissue as a graft in a human clinical study.
主な研究課題は何ですか？
Does the use of a graft, with autologous ruptured ACL tissue sutured to its ends, in anterior cruciate ligament reconstruction decrease tunnel enlargement and improve clinical results when compared to conventional ACLR, 2 years after treatment intervention?
重要な知見は？
- Tunnel enlargement was significantly less in the ruptured tissue group compared to the conventional (control) group in both femoral tunnels (AM and PL). Femoral AM tunnel enlargement ratios were 84.6% +/- 15.9 and 119.5% +/- 24.1 in the ruptured tissue and control groups respectively (p=0.0283). Ratios for the PL tunnel were 84.2% +/ -14.0 compared to 151.3% +/- 23.8, respectively (p=0.0090).
- Tunnel enlargement for femoral AM and PL tunnels were not significantly different between groups. Enlargement ratios for tibial AM tunnel were 71.0% +/- 11.2% versus 77.8% +/- 15.4% for the ruptured tissue group and control group, respectively, and 65.8% +/- 10.8% versus 96.9% +/- 30.5 for the PL tunnel (p>0.05 for both comparisons).
- Clinical outcome measures at 2 years postoperative did not differ significantly between the ruptured tissue group and control group: Mean Lysholm scores were 92.6 vs 93.0, respectively, anterior knee stability 1.4 vs 1.0, and pivot-shift test results 4/5 in both groups (p>0.05 for all).
最も覚えておくべきことは？
Tunnel enlargement of the femoral AM and PL tunnels were both significantly reduced in the ruptured tissue group compared to the conventional group. Tibial tunnel enlargement was comparable between techniques. Additionally, Lysholm scores, anterior knee stability, and pivot-shift tests were not significantly different between groups.
それが私の患者ケアにどのように影響するか？
Double-bundle ACLR using grafts of autologous ruptured ACL tissue sutured to doubled semitendinosus tendons appeared to yield less femoral tunnel widening while providing similar clinical outcomes when compared to a conventional technique. Findings from this pilot study warrant larger next-phase trials in populations of a wider age range. Additionally, further research is needed to elicit the healing mechanism of this technique.
免責事項
このページに記載されている内容は、情報提供のみを目的としたものであり、専門的な医療アドバイス、診断、治療の代わりとなるものではありません。治療が必要な場合は、必ず医師の診断を仰ぐか、最寄りの救急外来を受診してください。このページに記載されている内容に関して個人が表明した意見、信念、見解は、OrthoEvidenceの意見、信念、見解を反映するものではありません。
0の4 月間無料記事のロック解除
