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Arthroscopic Rotator Cuff Repair with and without Acromioplasty in the Treatment of Full-Thickness Rotator Cuff TearsA Multicenter, Randomized Controlled Trial
Peter MacDonald, MD, FRCSC1; Sheila McRae, MSc1; Jeffrey Leiter, MSc, PhD1; Randy Mascarenhas, MD1; Peter Lapner, MD, FRCSC2
1 Section of Orthopaedic Surgery, Department of Surgery, Pan Am Clinic/University of Manitoba, 75 Poseidon Bay, Winnipeg, MB R3M 3E4, Canada. E-mail address for P. MacDonald: pmacdonald@panamclinic.com
2 Critical Care Wing, Ottawa Hospital, General Campus, W1648, Box 502, 501 Smyth Road, Ottawa, ON K1H 8L6, Canada
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at Pan Am Clinic and University of Manitoba, Winnipeg, Manitoba, and Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Nov 02;93(21):1953-1960. doi: 10.2106/JBJS.K.00488
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Abstract

Background: 

The primary objective of this prospective randomized controlled trial was to compare functional and quality-of-life indices and rates of revision surgery in arthroscopic rotator cuff repair with and without acromioplasty.

Methods: 

Eighty-six patients consented and were randomly assigned intraoperatively to one of two study groups, and sixty-eight of them completed the study. The primary outcome was the Western Ontario Rotator Cuff (WORC) index. Secondary outcome measures included the American Shoulder and Elbow Surgeons (ASES) shoulder assessment form and a count of revisions required in each group. Outcome measures were completed preoperatively and at three, six, twelve, eighteen, and twenty-four months after surgery.

Results: 

WORC and ASES scores improved significantly in each group over time (p < 0.001). There were no differences in WORC or ASES scores between the groups that had arthroscopic cuff repair with or without acromioplasty at any time point. There were no differences in scores on the basis of acromion type, nor were any interaction effects identified between group and acromion type. Four participants (9%) in the group that had arthroscopic cuff repair alone, one with a Type-2 and three with a Type-3 acromion, required additional surgery by the twenty-four-month time point. The number of patients who required additional surgery was greater (p = 0.05) in the group that had arthroscopic cuff repair alone than in the group that had arthroscopic cuff repair and acromioplasty.

Conclusions: 

Our findings are consistent with previous research reports in which there was no difference in functional and quality-of-life indices for patients who had rotator cuff repair with or without acromioplasty. The higher reoperation rate was found in the group without acromioplasty. Further study that includes follow-up imaging and patient-reported outcomes over a greater follow-up period is needed.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Daniel Bronsnick, MD and Benjamin Goldberg, MD
    Posted on July 24, 2012
    Response to Peter B MacDonald, Sheila Mcrae, Jeff Leiter, Randy Mascarenhas, Peter Lapner
    University of Illinois at Chicago

    We are writing in response to the comments on the article, “Arthroscopic Rotator Cuff Repair with and without Acromioplasty in the Treatment of Full-Thickness Rotator Cuff Tears: A Multicenter, Randomized Controlled Trial” by McDonald et al. In the article, the authors stated that the Fisher exact test was used to determine significance of the rate of reoperation and that the significance was defined as p <0.05.  However, we ran this calculation (see comments, Daniel Bronsnick, MD and Benjamin Goldberg, MD, Posted on June 27, 2012, Disagreement Concerning the Statistical Significance of Reoperation Rates Between the Groups undergoing Arthroscopic Rotator Cuff Repair With and Without Acromioplasty) using the data available and noted that the p value when using the Fisher exact test was 0.118, which was not significant. Analyzing the data with multiple possible statistical tests including chi square with and without Yates correction also yielded non-significance of p>0.05. However, the authors' reply to our comments mention the Chi Square test without the Yates Correction. First, this p value was not significant as the p value was >0.05. Additionally, this test was not mentioned in the methods section of their paper. Finally, running a Chi Square without Yates correction is not appropriate due to their small sample size as 2 cells in the 2x2 contingency table had expected and actual values of less than 5. Thus, as there is not a statistical test (even an incorrect test) that can give significance of p<.05 to whether there is an increased operative incidence in patients being treated without acromioplasty and the authors do not question the statistics calculated in our comments, we would request that the authors modify their conclusions to state that there is NO DIFFERENCE in the re-operation rate in their study.

    Peter B MacDonald, Sheila Mcrae, Jeff Leiter, Randy Mascarenhas, Peter Lapner
    Posted on July 18, 2012
    Response to comment by Bronsnick and Goldberg
    University of Manitoba

    We thank the authors for their comment considering statistical significance of re-operation rates between the groups. The p value for the chi-square without Yates correction was p=0.0506. This with presented as a value of 0.05 which is consistent with common research practices in other publications. The most appropriate statistical analysis of this data set is a matter that is open to debate. However, the primary conclusion of the manuscript was that our findings are consistent with previous research reports in which there was no difference in functional and quality-of-life indices for patients who had rotator cuff repair with or without acromioplasty. A higher reoperation rate was found in the group without acromioplasty, according to our analysis, but this is an area that is somewhat complex to analyze in the context of whether valid conclusions can be made. The whole issue of reoperation rate is an interesting finding but something that, in our opinion, has to be viewed with caution and should not be considered the main thrust of the article. Thank you again for your interest in the article.

    Daniel Bronsnick, MD and Benjamin Goldberg, MD
    Posted on June 27, 2012
    Disagreement Concerning the Statistical Significance of Reoperation Rates Between the Groups undergoing Arthroscopic Rotator Cuff Repair With and Without Acromioplasty
    University of Illinois at Chicago

    We read the article by McDonald et al. with interest(1). This article concluded that there is a statistically significant lower incidence in reoperation rates between patients undergoing rotator cuff repair when undergoing acromioplasty compared to patients treated without acromioplasty. This is not consistent with our long term experience in treating rotator cuff tears without acromioplasty(2), and we closely examined this paper to determine potential explanations for differences with our typical results. Based upon our review of their paper, it appears that a statistical calculation was performed incorrectly, which could explain the different conclusions with our experience. The methods and results section of their paper stated they used the Fisher exact test to determine a statistically significant difference between these two groups using a p value of less than 0.05(1). While we agree with the use of the Fisher exact test as opposed to the Chi Square test to evaluate this data due to the small sample size(3,4,5) we disagree with the outcome of the Fisher exact test being statistically significant. In Figure 1, we have established a 2 x 2 contingency table of the published data using the information contained in the appendix of the study by McDonald et al.(1). Essentially, there were 4 candidates for reoperation in the non-acromioplasty group out of 45 patients. In the acromioplasty group, there were 0 candidates for reoperation out of 41 patients. Using IBM SPSS Statistics, Version 20 (Somers, NY 2011), we found a two tailed p-value to be 0.118, which is not statistically significant. Although a two tailed p-value is appropriate for this data set to truly have a null hypothesis, even if the authors used a one tailed Fisher exact test, the p-value is calculated at 0.070 which is also not statistically significant (Figure 2). Additionally, even if a Chi Square test was used without a Yates correction(6) (which is not appropriate due to the small sample size and is only an approximation as opposed to an “exact” comparison), it is still not significant with a p=0.051. If a Chi Square test is used with the Yates correction (used when one cell of the table has an expected count smaller than 5), the p value is 0.149. As there is no statistically different rate in patients being reoperated on either with or without acromioplasty, the conclusions of the authors are not supported by their results.

    Figure 1
                                               Reoperation            No Reoperation           Total

    Acromioplasty Group                0                                41                           41
    Non Acromioplasty Group        4                                41                           45
    Total                                            4                                82                           86

     

    Figure 2
                                                       Value          df       Asymp. Sig.          Exact Sig.           Exact Sig. Test
                                                                                     (2-sided)               (2-sided)              (1-sided)

    Pearson Chi-Square                   3.822a        1           .051
    Continuity Correctionb               2.081         1           .149
    Likelihood Ratio                          5.359         1            .021
    Fisher's Exact Test                                                                                    .118                          .070
    Linear-by-Linear Association     3.778          1           .052
    N of Valid Cases                               86

    a 2 cells (50.0%) have expected count less than 5. The minimum expected count is 1.91.
    b Computed only for a 2x2 table

    REFERENCES
    1. MacDonald P, McRae S, Leiter J, Mascarenhas R, Lapner P. “Arthroscopic Rotator Cuff repair With and Without Acromioplasty in the Treatment of Full Thickness Rotator Cuff Tears”. J Bone Joint Surg Am. 2011 Nov 2;93(21):1953-60.

    2. Goldberg BA, Lippitt SB, Matsen FA 3rd. Improvement in comfort and function after cuff repair without acromioplasty. Clin Orthop Relat Res. 2001 Sep;(390):142-50.

    3. Yates, F. (1984). 'Tests of Significance for 2 x 2 Contingency Tables (with discussion)'. Journal of the Royal Statistical Society, Ser. A 147 (3): 426–463.

    4. Agresti, Alan (1992). 'A Survey of Exact Inference for Contingency Tables'. Statistical Science 7 (1): 131–153.

    5. Liddell, Douglas (1976). 'Practical tests of 2x2 contingency tables'. The Statistician 25 (4): 295–304

    6. Yates, F (1934). 'Contingency table involving small numbers and the χ2 test'. Supplement to the Journal of the Royal Statistical Society 1(2): 217–235

    Peter MacDonald, Sheila McRae, Jeff Leiter, Randy Mascarenhas, Peter Lapner
    Posted on January 25, 2012
    Response to Comment from Dr. Jeremy Gililland and Dr. Robert Burks
    University of Manitoba, Pan Am Clinic, Ottawa Hospital

    We thank contributors Drs. Gililland and Burks for their insights regarding our study. As in any study, there were many ways to analyze and interpret our data. With respect to patients undergoing rotator cuff repair, we concur with our colleagues that there may be some clinically relevant differences between those with Type I and II acromions compared to those with Type III that may indicate acromioplasty is warranted. However, we do not feel we currently have adequate data to substantiate such a statement. Based on further analyses, we are able to state that the number of patients with Type III acromions having RC repair without acromioplasty that would be result in one patient requiring further surgery is 4.5, based on an absolute risk increase of 22% between Types I and II combined compared to Type III. That being said, we only had 3 patients with type III acromions that went on to have additional acromiplasty surgery within 2 years of their initial rotator cuff surgery (the end point of our study). We require further long-term follow-up on a greater number of patients to gain understanding as to whether this additional surgery actually led to further improvement.

    Jeremy M Gililland MD, Robert T Burks MD
    Posted on January 05, 2012
    In the Setting of Rotator Cuff Repair, Acromioplasty May Be Indicated for Type 3 Acromions
    University of Utah Department of Orthopaedic Surgery

    In the study by MacDonald et al., a multi-center randomized controlled trial was performed in which patients were randomized to arthroscopic rotator cuff repair with or without acromioplasty.(1) We commend the authors on successfully completing a prospective multicenter randomized study, as this is a very difficult undertaking. The conclusion from this study was that acromioplasty provides no difference in functional or quality-of-life indices for patients receiving rotator cuff repair. If we group all types of acromions together, this conclusion is valid based on the data presented. The authors state in their results that acromion type did not have any interaction effect on the WORC or ASES outcome scores. However, when we look at the data presented in Table II, we feel that the opposite interpretation can be made. The authors included patients with Type-1, Type-2, and Type-3 acromion in their study. The study was statistically powered only for a total sample analysis, and so underpowered for a subgroup analysis and underpowered for assessing study group by acromion type interaction. If one graphically plots the change in mean WORC and ASES scores at each post-operative time point as compared to the initial mean pre-operative scores for each acromion type there does not appear to be much benefit from acromioplasty in type 1 and 2 acromions as these curves are nearly identical for both WORC and ASES scores. However, when looking at the same plots for type 3 acromions, there certainly seems to be a trend toward a benefit from acromioplasty with seemingly higher delta WORC and ASES scores at almost every time point, most notably at 2-year follow-up. In addition, the authors state that 9% of the non-acromioplasty patients required reoperation for ongoing symptoms compared to no re-operations in the acromioplasty group. A more striking summation of this re-operation data is that 25% of the type 3 acromions treated without acromioplasty required revision surgery for continued symptoms compared to only 4% of the type 2 acromions and none of the type 1 acromions. This data further supports our interpretation of the outcome score data seen in table II as again, acromioplasty seems to be equivocal for types 1 and 2 acromions while providing benefit for type 3 acromions. Based on the data published recently by Vitale et al., acromioplasty has undoubtedly been over utilized in recent years as “the indication for acromioplasty has become too broad.”(2) This study by MacDonald et al. provides us with some level I evidence that ubiquitous utilization of acromioplasty does not improve functional or quality-of-life indices for our patients in the setting of rotator cuff repair. However, we feel that this study also shows us that acromioplasty in the setting of rotator cuff repair can be indicated for type 3 acromions as it improves outcomes and decreases re-operation rates for ongoing pain in these patients. REFERENCES: (1) MacDonald P, McRae S, Leiter J, Mascarenhas R, Lapner P. Arthroscopic Rotator Cuff Repair with and without Acromioplasty in the Treatment of Full-Thickness Rotator Cuff Tears: A Multicenter, Randomized Controlled Trial. The Journal of Bone and Joint Surgery. 2011 Nov 02;93(21):1953-60. (2) Vitale MA, Arons RR, Hurwitz S, Ahmad CS, Levine WN. The Rising Incidence of Acromioplasty. The Journal of Bone and Joint Surgery. 2010 Aug 04;92(9):1842-50.

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