SPORTS MEDICINE
All-inside meniscal repair with bioabsorbable meniscal screws or with bioabsorbable meniscus arrows: A prospective, randomized clinical study with 2-year results
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):203 Am J Sports Med. 2010 Nov;38(11):2211-7.42 patients undergoing all-inside meniscal repair were randomized to be treated with bioabsorbable meniscal arrows or meniscal screws, with the hypothesis that similar clinical outcomes would be seen at short-term follow-up for meniscal repair. At an average follow-up time of 27 months, the clinical outcomes, measured Lysholm score and the International Knee Documentation Committee (IKDC) knee score, were similar, except the arrow group showed significantly greater chondral damage.
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。
3/4
Randomization
3/4
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？
The recommended treatment for meniscal tears is to repair the tear and to save the menisci whenever possible. The focus now has shifted towards all-inside meniscal repair techniques.At present, there is a lack of prospective randomized clinical studies that compare these different all-inside meniscal repair devices. In a 2 year study period, this trial compared 2 such techniques: repair with the bioabsorbable Trinion meniscal screw and repair with the bioabsorbable meniscus arrow.
主な研究課題は何ですか？
Are there any differences in clinical and radiographic outcomes of an all inside meniscal repair with the use of bioabsorbable meniscal screw and bioabsorbable meniscal arrow 2 years after surgery?
重要な知見は？
- The Lysholm score, the IKDC function score, and the IKDC final score reported no significant difference between the groups preoperatively and at the 2-year follow-up.
- In the meniscal arrow group, mild chondral damage (grade I) was observed in 5 patients in the medial femoral condyle on the same side as the meniscal repair, while In the screw group, no chondral damage was observed (p = 0.008).
- 17% of the screw group and 30% in the arrow group had failures (P = 0.242)
- The meniscal healed in 14 patients (8 in the screw group and 6 in the arrow group), and as partially healed in 4 patients (3 in the screw group and 1 in the arrow group).
- No significant differences were seen in tenderness in the joint line by McMurray test at 2 year follow up.
- All knees were stable and similar proportion of patients were able to carry out same level sporting activity (15 vs 12) or at a lower level activity (2 in each group)
最も覚えておくべきことは？
All-inside meniscal repair with bio-absorbable meniscal screws and arrows resulted in similar clinical outcomes. However, significantly more chondral damage was observed when patients received arrows for fixation. The authors discontinued the study for ethical reasons based on the observed chondral damage findings.
それが私の患者ケアにどのように影響するか？
According to the study findings, it was suggested that meniscal repair performed with bioabsorbable meniscal screws resulted in better results than the meniscal repair with bioabsorbable meniscus arrows. The use of meniscal arrows for fixation was associated with significant chondral damage.
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