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RCT
ACE Report #9222

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


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

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

Acta Orthop. 2016 Aug;87(4):351-5

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Synopsis

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.

Publication Funding Details +
Funding:
Not Reported
Conflicts:
None disclosed

Risk of Bias

5.5/10

Reporting Criteria

8/20

Fragility Index

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)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

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

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

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.

What was the principal research question?

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?

Study Characteristics -
Population:
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.
Intervention:
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)
Comparison:
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)
Outcomes:
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).
Methods:
RCT; assessor-blind
Time:
Follow-up scheduled for 5 years.

What were the important findings?

  • 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).

What should I remember most?

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.

How will this affect the care of my patients?

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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