ARTHROPLASTY
Is There an Advantage to Knotless Barbed Suture in TKA Wound Closure? A Randomized Trial in Simultaneous Bilateral TKAs
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(2):1 Clin Orthop Relat Res. 2015 Jun;473(6):2019-2750 patients undergoing bilateral total knee arthroplasty (TKA) were randomly assigned to undergo closure with knotless bidirectional barbed sutures in one knee and standard sutures in the other. The purpose of this study was to determine whether there is a superior technique in terms of clinical outcomes and cost-effectiveness. Findings of this study determined knotless bidirectional barbed sutures to be more effective for closure time and direct operative cost compared to standard sutures. However, Knee Society Scores, range of motion (ROM), and wound appearance were comparable between methods.
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
Randomization
4/4
Outcome Measurements
3/4
Inclusion / Exclusion
4/4
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？
In total knee arthroplasty, wound closure is necessary to minimize postoperative wound complications and to withstand forces in order to prevent reopening of the incision during early knee motion. Cadaver model trials and biomechanical testing have suggested that knotless bidirectional barbed sutures have greater efficacy in providing sufficient wound closure and a higher resistance to failure when compared with standard sutures. However, previous studies have reported more prevalent postoperative wound complications in this method, and therefore, the relevance of bidirectional barbed sutures is still under debate. Thus, the present study was designed to determine an optimal approach to wound closure in TKA by using bilateral TKA patients.
主な研究課題は何ですか？
Are knotless bidirectional barbed sutures superior to standard sutures in terms of wound closure and the resulting clinical and cost outcomes in bilateral total knee arthroplasty, when assessed up to 1 year postoperatively?
重要な知見は？
- Wound closure time was significantly faster in the barbed suture group (11.4 +/- 2.2 minutes) compared to the standard suture group (16.1 +/- 2.2 minutes) (Meantime diff: 4.7 +/- 2.8 minutes 95% CI -5.5 to -3.7; p<0.001)
- No significant differences were found in overall tourniquet time between both groups (barbed: 78.7 +/- 11.1 minutes; standard: 74.9 +/- 10.1 minutes; p=0.11)
- Wound complications were comparable between the two approaches
- Number of suture handoffs were significantly less with barbed sutures (7 - 9) compared to standard sutures (14 - 16) (p<0.001)
- Significantly more suture breakages and premature disengagements were seen using the standard approach compared to the barbed approach (3 suture breakages and 5 premature disengagements compared to none in the barbed approach; p<0.005)
- No significant differences were seen between groups when assessing ROM before discharge (barbed mean: 100.2 +/- 7.59 deg., standard mean: 99.8 +/- 15.43 deg.; 95% CI -4.47 to 5.28; p=0.8) or at 1 year follow-up (barbed mean: 126.7 +/- 6.9 deg., standard mean: 125.6 +/- 7.0 deg.; 95% CI -3.77 to 1.73; p=0.4)
- Knee Society knee scores were comparable between both barbed and standard groups at 3 months follow-up (barbed mean: 89.2 +/- 7.27, standard mean: 90.4 +/- 5.79; 95% CI, 23.84 to 1.43; p=0.37) and at 1-year follow-up (barbed mean: 92.8 +/- 6.69, standard mean: 93.3 +/- 6.2; 95% CI, 21.97 to 3.36; p = 0.6)
- Material costs of barbed sutures were higher than standard sutures, however; barbed sutures were cost beneficial in faster wound closure and reduction in operating room time
最も覚えておくべきことは？
Significantly faster wound closure time was seen in knotless bidirectional barbed sutures compared to standard sutures in bilateral total knee arthroplasty patients. Additionally, barbed sutures were found to be more efficient in direct cost. No differences in the range of motion or Knee Society knee scores were seen between wound closure approaches.
それが私の患者ケアにどのように影響するか？
Knotless bidirectional barbed sutures were determined to have greater efficacy with relation to wound closure time and lower direct operative costs compared to standard sutures in TKA. However, results were comparable between the two suture methods when measured for range of motion and Knee Society knee scores. Further studies with larger population sizes should be conducted to yield more conclusive results.
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