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Scientific Articles   |    
Operative versus Nonoperative Treatment of Acute Achilles Tendon RupturesA Multicenter Randomized Trial Using Accelerated Functional Rehabilitation
Kevin Willits, MA, MD, FRCSC1; Annunziato Amendola, MD, FRCSC2; Dianne Bryant, MSc, PhD3; Nicholas G. Mohtadi, MD, MSc, FRCSC4; J. Robert Giffin, MD, FRCSC1; Peter Fowler, MD, FRCSC1; Crystal O. Kean, MSc, PhD1; Alexandra Kirkley, MD, MSc, FRCSC5
1 WOLF Orthopaedic Biomechanics Lab (C.O.K.), Fowler Kennedy Sport Medicine Clinic (K.W., J.R.G., and P.F.), 3M Centre, The University of Western Ontario, London, ON N6A 3K7, Canada. E-mail address for K. Willits: kwillit@uwo.ca. E-mail address for J.R. Giffin: rgiffin@uwo.ca. E-mail address for C.O. Kean: ckean@unimelb.edu.au. E-mail address for P. Fowler: pfowler@uwo.ca
2 University of Iowa Sports Medicine, The University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52242. E-mail address: ned-amendola@uiowa.edu
3 Orthopaedic Division, Department of Surgery, Elborn College, Room 1438, The University of Western Ontario, London, ON N6G 1H1, Canada. E-mail address: dianne.bryant@uwo.ca
4 University of Calgary Sport Medicine Centre, 2500 University Drive N.W., Calgary, AB T2N 1N4, Canada. E-mail address: mohtadi@ucalgary.ca
5 Deceased
View Disclosures and Other Information
Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Physicians Services, Inc. (PSI) and Aircast, Inc. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

A commentary by Michael S. Aronow, MD, is available at www.jbjs.org/commentary and is linked to the online version of this article.
Investigation performed at the Fowler Kennedy Sport Medicine Clinic, London, Ontario, and the University of Calgary Sport Medicine Centre, Calgary, Alberta, Canada

Copyright © 2010 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2010 Dec 01;92(17):2767-2775. doi: 10.2106/JBJS.I.01401
A commentary by Michael S. Aronow, MD, is available here
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Abstract

Background: 

To date, studies directly comparing the rerupture rate in patients with an Achilles tendon rupture who are treated with surgical repair with the rate in patients treated nonoperatively have been inconclusive but the pooled relative risk of rerupture favored surgical repair. In all but one study, the limb was immobilized for six to eight weeks. Published studies of animals and humans have shown a benefit of early functional stimulus to healing tendons. The purpose of the present study was to compare the outcomes of patients with an acute Achilles tendon rupture treated with operative repair and accelerated functional rehabilitation with the outcomes of similar patients treated with accelerated functional rehabilitation alone.

Methods: 

Patients were randomized to operative or nonoperative treatment for acute Achilles tendon rupture. All patients underwent an accelerated rehabilitation protocol that featured early weight-bearing and early range of motion. The primary outcome was the rerupture rate as demonstrated by a positive Thompson squeeze test, the presence of a palpable gap, and loss of plantar flexion strength. Secondary outcomes included isokinetic strength, the Leppilahti score, range of motion, and calf circumference measured at three, six, twelve, and twenty-four months after injury.

Results: 

A total of 144 patients (seventy-two treated operatively and seventy-two treated nonoperatively) were randomized. There were 118 males and twenty-six females, and the mean age (and standard deviation) was 40.4 ± 8.8 years. Rerupture occurred in two patients in the operative group and in three patients in the nonoperative group. There was no clinically important difference between groups with regard to strength, range of motion, calf circumference, or Leppilahti score. There were thirteen complications in the operative group and six in the nonoperative group, with the main difference being the greater number of soft-tissue-related complications in the operative group.

Conclusions: 

This study supports accelerated functional rehabilitation and nonoperative treatment for acute Achilles tendon ruptures. All measured outcomes of nonoperative treatment were acceptable and were clinically similar to those for operative treatment. In addition, this study suggests that the application of an accelerated-rehabilitation nonoperative protocol avoids serious complications related to surgical management.

Level of Evidence: 

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

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    References

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    Muralidharan Venkatesan, Nick Taub, Professor Joseph J Dias
    Posted on July 25, 2011
    Operative versus non-operative treatment of acute Achilles tendon ruptures
    Deapartment of Trauma and Orthopaedics, University Hospitals of Leicester, United Kingdom

    Sir, Our journal club read with interest the article of Willits et al (1) in the December 2010 issue entitled ‘Operative versus non-operative treatment of acute Achilles tendon ruptures’. While we commend the authors for their multicenter prospective randomized trial, we wish to comment following points: despite extensive commentary by Aronow (2), correspondence following its publication and, presumably, review by JBJS statistical advisors prior to its publication, discrepancies in figures quoted appear to have gone unnoticed. The meta-analysis paper by Lo et al (3) referenced for the power analysis gives re-rupture rates of 2.8% and 11.7% for operative and non-operative treatment respectively, whereas the Willits paper quotes 2.5% and 13%, and then based the sample size calculation on the detection of an underlying difference of 11%. Our own calculation of sample size for a ‘one-sided’ 80% power comparison of re-rupture rates corresponding to the Lo et al results, with the standard allowance for the statistical ‘continuity correction’ indicates that 126 patients would be needed in each group, and a considerably greater number if the comparison was to be two-sided. These discrepancies are not minor and impacted the power of the study. It is mandatory that at the outset study be powered properly to optimize the resource usage and design of a study, improving chances of conclusive results. This multicenter study was not properly powered and the fact it was categorized as a Level 1 therapeutic study cannot be upheld and is misleading. References: 1. Willits K, Amendola A, Bryant D, Mohtadi N G, Giffin J R et al. Operative versus non-operative treatment of acute Achilles tendon ruptures: A multicenter randomized trial using accelerated functional rehabilitation. J Bone Joint Surg Am. 2010; 92:2767-2775. 2. Aronow MS. Commentary on an article by Kevin Willits, MA, MD, FRCSC, et al.: 'Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation'. J Bone Joint Surg Am. 2010; 92:e32. 3. Lo IK, Kirkley A, Nonweiler B, Kumbhare DA. Operative versus non-operative treatment of acute Achilles tendon ruptures: a quantitative review. Clin J Sport Med. 1997; 7:207-11.

    Christopher J. Pearce
    Posted on February 11, 2011
    Letter to the Editor
    Consultant Orthopaedic Surgeon, Royal Surrey County Hospital, United Kingdom

    To the Editor:

    We read with interest the paper by Willits et al. entitled, "Operative versus Nonoperative Treatment of Acute Achilles Tendon Ruptures: A Multicenter Randomized Trial Using Accelerated Functional Rehabilitation" (2010;92:2767-75). Whilst the authors are to be congratulated for conducting a multicenter PRCT we have the following comments:

    The major problem is the conclusion drawn about rerupture rate. Aronow in his commentary (1) correctly points out that, "the study was underpowered because of a much lower than expected rerupture rate with nonoperative treatment", but this is not the full explanation. The power analysis was conducted to detect a difference in rerupture rate of between 2.5% and 13% between operative and non-operative treatment. This was misleadingly reported as being a difference of 11%. It should be noted to be a greater than 5-fold increase. A power analysis that we have conducted, using the authors' data, shows that the numbers needed to detect a doubling of rerupture rate from 2 to 4%, which we would consider clinically significant, with power 80% and alpha 5% is 966 patients per group (a tripling would require 331 patients in each). The study was actually underpowered even to detect a 5-fold difference as their own analysis required 77 patients but they only recruited 72.

    Surgeons, authors and journal reviewers must remember that statistics are used to set the level of "risk" that observed differences between treatment groups are due solely to chance, or that real differences will be undetected. By choosing 95% confidence limits we accept that there is a 5% risk that any observed difference is there by chance. Power set at 80% means that the study will detect a real difference 80% of the time. Convention dictates that these thresholds for medical research are reasonable. An underpowered study falls short of these standards and the results become at best meaningless and at worst dangerously misleading.

    This study attempts to determine whether there are differences in outcome between non-operative and operative treatment of Achilles tendon rupture when both are subject to an accelerated rehabilitation program. This question is an important one, but an underpowered study, even when otherwise well designed, can only serve to confuse and should not be cited as evidence of an equivalent outcome.

    Reference

    1. Aronow MS. Commentary on an article by Kevin Willits, MA, MD, FRCSC, et al.: "Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation". J Bone Joint Surg Am. 2010;92:e32.

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