SHOULDER & ELBOW
A Midterm Evaluation of Postoperative Platelet-Rich Plasma Injections on Arthroscopic Supraspinatus Repair: A Randomized Controlled Trial
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2018;6(9):13 Am J Sports Med. 2017 Nov;45(13):2965-297460 patients with an isolated, full-thickness supraspinatus tear were randomized to either receive two postoperative ultrasound-guided injections of platelet-rich plasma or to no adjunct postoperative intervention. Patients were evaluated over a mean of 3.5 years for MRI (Sugaya classification) and clinical outcomes (QuickDASH, Oxford Shoulder Score, and Constant Score). At a mean of 3.5 years, there were no significant differences in clinical scores between groups, with the exception of a greater score on the abduction subscale of the Constant score in the PRP group. MRI outcomes were similar between groups at final follow-up.
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
4/5
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？
Arthroscopic repair of a rotator cuff tear, though often clinically effective, suffers from a fairly high rate of retear. Platelet-rich plasma, applied either intraoperatively or as a postoperative injection, has been suggested to improve tendon healing and reduce the rate of retear. While a number of trials have reported short-term outcomes following the use of adjunct PRP therapy, few trials have provided medium-term follow-up.
主な研究課題は何ですか？
In arthroscopic supraspinatus repair, do postoperative injections of platelet-rich plasma at 7 and 14 days after surgery result in a significantly lower rate of tendon retear on MRI, over an average of 42 months of follow-up, when compared to patients who were not administered postoperative injections?
重要な知見は？
- At the mean follow-up time of 3.5 years, there were no differences in QuickDash, Oxford shoulder score, or the total Constant score between groups (p>0.05). A higher score on the strength subscale of the Constant score was observed in the PRP group (p=0.006).
- There were no differences in MRI scores or retear rates between groups, with 66.7% of the PRP group and 64.3% of the control patients rated as grade 1 using the Sugaya classification system.
最も覚えておくべきことは？
In arthroscopic supraspinatus repair, there were no significant differences in clinical or MRI outcomes between patients receiving or not receiving adjunct postoperative platelet-rich plasma injections, with the exception of a possible improvement in abduction strength.
それが私の患者ケアにどのように影響するか？
The use of platelet-rich plasma injections as an adjunct therapy following arthroscopic supraspinatus repair does not appear to provide considerable benefit in either MRI or clinical outcomes for patients at medium-term follow-up.
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