SPORTS MEDICINE
Skin-derived tenocyte-like cells for the treatment of patellar tendinopathy
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(3):25 Am J Sports Med. 2011 Mar;39(3):614-23. doi: 10.1177/0363546510387095. Epub 2010 Dec 746 patients (60 patellar tendons) were randomized to assess the efficacy of ultrasound-guided injection of autologous skin-derived, tenocyte-like cells in treating refractory patellar tendinosis. Patients received either injection with collagen-producing cells suspended in autologous plasma or injection with autologous plasma alone (control). The assessment at 6 months indicated that ultrasound-guided injection of autologous skin-derived tendon-like cells led to a significantly greater improvement in pain and function in comparison to control injections.
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
3/4
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？
The optimal treatment method, whether surgical or nonoperative, for patellar tendinopathy remains unclear. Recently, there has been an increasing focus on ultrasound-guided interventional procedures for the treatment of patellar tendinopathy. For example, the use of tissue engineering (using stem cells) has led to tendon regeneration in animal studies. However, there is uncertainty regarding the type of cell and tissue source that should be used to produce optimal results. Therefore, this study aimed to assess the efficacy of ultrasound-guided injection of autologous skin-derived, tenocyte-like cells in treating refractory patellar tendinosis.
主な研究課題は何ですか？
Was the ultrasound-guided injection of autologous skin-derived, tenocyte-like cells more effective in treating patellar tendinopathy in comparison to injection with plasma alone, assessed at 6 months?
重要な知見は？
- After 6 months, there was a greater improvement in VISA scores for the cell group (44 +/- 15 to 75 +/- 17) when compared to the plasma group (50 +/- 18 to 70 +/- 14); the mean difference was 8.1 (95% CI, 2.4 to 13.7; P = 0.006).
- The cell group demonstrated significantly faster improvement and a highly significant effect of treatment in comparison to the plasma group, with the between-group difference estimated as 2.5 per unit increase in 1/square-root of time (95% CI, 0.9 to 4.1; P = 0.002).
- In respect to changes in ultrasound appearances, both groups revealed a significant decrease in hypoechogenicity and tear size (both P < 0.05); however, no significant difference was observed for neovascularity (cell group: P = 0.7248; plasma group: P = 0.6508), while a significant decrease in tendon thickness was observed only for the cell group (P = 0.0072).
最も覚えておくべきことは？
Ultrasound-guided injection of autologous skin-derived, tenocyte-like cells was more effective in improving pain and function in comparison to control injections with plasma alone.
それが私の患者ケアにどのように影響するか？
This study suggests that ultrasound-guided injections of skin-derived collagen-producing cells are safe and effective in the short-term for the treatment of patellar tendinopathy. Future research is required to further evaluate the application of this technique, including the number of injections and use in other tendon overuse conditions.
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