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Acromioplasty does not reduce the rate of rotator cuff ruptures in shoulder impingement
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SHOULDER & ELBOW

No difference in long-term development of rotator cuff rupture and muscle volumes in impingement patients with or without decompression

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2016;4(20):13 Acta Orthop. 2016 Aug;87(4):351-5

140 patients with shoulder impingement syndrome were randomized to undergo arthroscopic acromioplasty followed by a home-based exercise therapy program, or an exercise therapy program alone. The purpose of this study was to evaluate if there were any significant differences between groups in the incidence of MRI-assessed rotator cuff tear, or muscle volume and fatty degeneration of the supraspinatus, infraspinatus, and subscapularis muscles, over a 5-year follow-up. The results demonstrated no significant difference in any of the listed outcomes.


出版資金提供の詳細 +
資金提供:
Not Reported
コンフリクト:
None disclosed

バイアスのリスク

5.5/10

報告基準

8/20

脆弱性指数

N/A

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。

1/4

Randomization

3/4

Outcome Measurements

2/4

Inclusion / Exclusion

0/4

Therapy Description

2/4

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 use of acromioplasty is a contentious issue in the management shoulder impingement syndrome. The most recent evidence has demonstrated little difference in overall outcome in the short-term compared to structured exercise programs. A possible long-term, protective effect of acromioplasty on rotator cuff tendons has been suggested, though this effect has not been previously studied in a randomized controlled trial.

主な研究課題は何ですか?

In patients with shoulder impingement syndrome, does arthroscopic acromioplasty significantly affect the rate of eventual rotator cuff tear on imaging, or volumes of the rotator cuff muscles, when compared to a structured exercise program alone over a 5-year follow-up?

研究の特徴 +
人口:
140 patients with symptomatic shoulder impingement syndrome for a minimum of 3 months, and severity grade II were included. Patients with a history of previous shoulder surgery were excluded.
介入:
Arthroscopic acromioplasty: All procedures were performed under general anaesthesia. Debridement and decompression were performed through an anterolateral portal. Coracoacromial ligament release was left to the discretion of the surgeon based on intraoperative observation. Postoperative rehabilitation was the same as the exercise therapy group (described below). (n=70 randomized; 57 analyzed at 5 years)
比較:
Exercise therapy: Patients met with a physiotherapist, who provided a tailored, home-based exercise program to be performed four times per week. Programs consisted of 9 exercises aimed to restore painless range of motion of the shoulder and to improve stability of the joint. Exercises were performed in sets of 3, each set consisting of 30-40 repetitions. Elastic bands and light weights were used to allow for progression of strength. (n=70 randomized; 52 analyzed at 5 years)
アウトカム:
A visual analog scale was used to assess pain (VAS 0-10) and pre- and postoperative MRIs were used to evaluate the development of rotator cuff tear or tendinosis. Additionally, acromion shape was assessed during MRI evaluation, and designated as type I (straight), type II (curved), or type III (hook). Volume of the supraspinatus, infraspinatus, and subscapularis muscles was used using T1-weight sagittal images. The muscles were also graded based on fatty degeneration, using a Stage scale (0 – 4).
方法:
RCT; assessor-blind
時間:
Follow-up scheduled for 5 years.

重要な知見は?

  • Full-thickness rotator cuff tears identified via MRI after 5 years were observed in 8 patients who had undergone arthroscopic acromioplasty and 7 patients who had performed exercise therapy alone.
  • There were no significant differences between the arthroscopic acromioplasty group and the exercise therapy group in muscle volume decrease after 5 years, either for the supraspinatus (-7% vs. -4%, respectively; p=0.6), the infraspinatus (p=0.9), or the subscapularis (p=0.5).
  • Fatty degeneration of any degree (stages 1-4) was observed in 65% of patients who underwent arthroscopic acromioplasty and 54% of patients who had performed exercise therapy alone (p=0.3).
最も覚えておくべきことは?

In the management of patients with grade II shoulder impingement syndrome, there were no significant differences between arthroscopic acromioplasty plus postoperative exercise therapy and exercise therapy alone when considering the development of full-thickness rotator cuff tear or muscle volume & fatty degeneration of the supraspinatus, infraspinatus, and subscapularis muscles after 5 years.

それが私の患者ケアにどのように影響するか?

The results of this study suggest that arthroscopic acromioplasty plus home-based exercise therapy does not reduce the rate of rotator cuff ruptures over a 5 year period compared to exercise therapy alone in patients with shoulder impingement syndrome. These results, in combination with data from earlier follow-up, which demonstrated no significant differences between groups in patient-reported symptomatic improvement, suggest that arthroscopic acromioplasty may not be justified in these patients.

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引用方法 ACE Report

OrthoEvidence. Acromioplasty does not reduce the rate of rotator cuff ruptures in shoulder impingement. OE Journal. 2016;4(20):13. Available from: https://myorthoevidence.com/AceReport/Show/acromioplasty-does-not-reduce-the-rate-of-rotator-cuff-ruptures-in-shoulder-impingement

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