SPORTS MEDICINE
Early controlled tension improves the material properties of healing human achilles tendons after ruptures: a randomized trial
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original publication.
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(3):32 Am J Sports Med. 2013 Nov;41(11):2550-735 patients with an acute Achilles tendon rupture were randomized to evaluate the benefits of early tensional loading on the mechanical properties of healing Achilles tendons, when compared to conventional cast treatment. Patients were evaluated over 52 weeks, and the evidence presented in this study indicated that elastic modulus was higher in the tensional loading group at 19 and 52 weeks and no significant differences were apparent between groups concerning the Achilles tendon Total Rupture Score (ATRS) or the heel raise index at 52 weeks. A significant correlation between the modulus at 7 weeks and the heel raise index at 52 weeks was observed and no signs of tendon elongation were noted.
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
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?
Achilles tendon ruptures result in lengthy periods of immobilization and rehabilitation, and while there is no consensus regarding an optimal method of fixation between operative and nonoperative interventions, a number of animal and clinical studies have demonstrated favorable outcomes associated with early motion and weight bearing. It remains unclear if these effects are caused by mechanical loading of the healing tendon or by motion of the ankle joint that reduced edema and other negative consequences of immobility. This study was consequently needed to investigate the efficacy of controlled tensional loading during the immobilization period in terms of an improvement in the mechanical properties of the healing Achilles tendon.
主な研究課題は何ですか?
Does controlled tensional loading during the immobilization improve the mechanical properties of the healing Achilles tendon, as evaluated over 52 weeks?
重要な知見は?
- Elastic modulus at 19 and 52 weeks was 35% higher (111 +/- 41 in the loading group vs. 82 +/- 29 in the control; 95% CI: 2 to 69), and 33% higher (355 +/- 116 in the loading group vs. 266 +/- 66 in the control; 95% CI: 7 to 59) in the loading group compared to the control. There were no significant differences between groups for ATRS and heel-raise index at 52 weeks.
- Mean transverse area of every patient doubled between 7 to 19 weeks. At 52 weeks, the area was 30% less than after 19 weeks but still greater than at plaster removal.
- Heel raise index was not significantly different between groups at 52 weeks at about 80% that of the intact side in both groups.
- At 7 weeks, the elastic modulus and the percentage of elongation of all tendons demonstrated a significant correlation with the heel raise index (p= 0.003 and p= 0.03 respectively. There correlations were weaker at 19 weeks (p= 0.08 and p= 0.07 respectively), with no apparent correlation at 52 weeks. Furthermore there was no correlation between the transverse area of the tendon with heel raise index, or between any of the variables for the mechanical properties at 7, 19 or 52 weeks, or the ATRS after 52 weeks.
- No significant difference between groups was apparent in tendon elongation at any time point. 2 outliers (control group) with an elongation of 28 and 31 mm were noted at 52 weeks.
- 1 loading group patient suffered a rerupture after 3 months. 1 patient reported considerable unexplained pain but showed good clinical results after 52 weeks. Another patient was excluded because of 3 of the 4 tantalum beads were placed outside the tendon disallowing elongation measurement. 2 patients in each group exhibited deep vein thrombosis.
最も覚えておくべきことは?
The elastic modulus was higher in the tensional loading group at 19 and 52 weeks. No significant differences were apparent between groups concerning the Achilles tendon Total Rupture Score (ATRS) or the heel raise index at 52 weeks. A significant correlation between the modulus at 7 weeks and the heel raise index at 52 weeks was observed. No signs of tendon elongation were noted.
それが私の患者ケアにどのように影響するか?
The evidence presented in this study demonstrated that early tensional loading improves the mechanical properties of the healing Achilles tendon. Note that this study was limited by the lack of appropriate blinding. Further research with large samples, patient-important outcome measures, and high methodological quality is needed to validate these findings.
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