FOOT & ANKLE
Autologous platelets have no effect on the healing of human achilles tendon ruptures: a randomized single-blind study
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by one or more authors of the
original publication.
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(5):29 Am J Sports Med. 2011 Jan;39(1):38-47. doi: 10.1177/0363546510383515. Epub 2010 Nov 3.Exclusive Author Interview
Dr. Per Aspenberg discusses PRP as an adjunctive treatment for acute Achilles tendon ruptures.
30 patients presenting with an acute Achilles tendon rupture were included in this randomized trial to investigate the effects of platelet-rich-plasma (PRP) in tendon healing. Patients were randomized to receive 10 ml of autologous PRP injected through a cannula into the rupture site following repair or repair with no additional treatment. Mechanical (E-modulus) and functional (heel raising index) outcomes were measured over a one year period. There were no differences in mechanical outcomes between the groups over the 1 year period, and both groups exhibited significant functional deficits compared to the uninjured limb.
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
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？
Rehabilitation following Achilles tendon rupture is a long and arduous process which is limited by the time required for the tendon the fully heal. A number of treatments have been developed in an attempt to expedite this healing and improve both functional and clinical outcomes. Platelet-Rich Plasma may be a promising possible treatment, having demonstrated an ability to increase fibrous tissue growth, tissue vascularity and improve tendon strength in animal models and retrospective clinical trials.
主な研究課題は何ですか？
Did the use of Platelet-Rich-Plasma improve tendon healing in patients with an acute rupture of the Achilles tendon compared to controls assessed at different time points over a 52 week period?
重要な知見は？
- There were no significant different in mechanical properties (E-modulus or transverse area) at any time point (7, 19 or 52 weeks) between the PRP or control groups (p>0.05).
- At 6 months there were significant deficits in function in the injured limb compared to the uninjured limb. These deficits were greatest in the more demanding tasks such as heal raising compare to range of motion. At 12 months there were still significant deficits in all functional outcomes except for peak force during toe-off in gait and vertical jumping.
- Functional outcome at 12 months measured using the heel raise index was not significantly different between the PRP and control group.
- Achilles Tendon Total Rupture Score was lower at 12 months for the PRP group (78; 75-85) compared to the controls (89; 83-92) (p=0.014)
- One patient in the PRP group had a re-rupture, no patients in the control group had re-ruptures.
最も覚えておくべきことは？
There were no benefits in the use of Platelet-Rich-Plasma following operative treatment of acute Achilles tendon ruptures. Patients demonstrated similar mechanical outcomes (E-modulus and transverse area) at all time points up to one year. Additionally, both groups demonstrated a significant deficit in functional ability measured using heel raise index compared to the uninjured limb at 6 and 12 months, while failing to exhibit any differences between groups. Achilles Tendon Total Rupture Score was the only functional measure that demonstrated a difference between groups at 12 months; this measure favoured the control group.
それが私の患者ケアにどのように影響するか？
The results from this study do not indicate any substantial benefit of the use of PRP in Achilles tendon healing following operative repair of an acute tendon rupture. The use of PRP may possibly have a negative effect on functional outcomes at 1 year. A major strength of this study was the use of objective measures of healing. Therefore, future research studies using larger sample sizes (along with the same objective assessments of healing) are required to definitively determine the effect of PRP in healing acute Achillies tendon ruptures.
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