The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 87, Issue 10

Scientific Articles | October 01, 2005

Treatment of Acute Achilles Tendon Ruptures: A Meta-Analysis of Randomized, Controlled Trials

Riaz J.K. Khan, FRCS(Tr&Orth)¹; Dan Fick, MBBS²; Angus Keogh, MBBS²; John Crawford, FRCS(Tr&Orth)³; Tim Brammar, FRCS(Tr&Orth)³; Martyn Parker, MD⁴

¹ Department of Orthopaedics, Norfolk and Norwich University Hospital, Colney Lane, Norwich, Norfolk, NR4 7UY, United Kingdom. E-mail address: riazkhan@aol.com
² Department of Surgery and Pathology, University of Western Australia, Perth, WA 6009, Australia
³ Addenbrooke's Hospital, Cambridge, CB2 2QQ, United Kingdom
⁴ Peterborough District Hospital, Peterborough, PE3 6DA, United Kingdom

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The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Investigation performed at Perth Orthopaedic Institute, Department of Surgery and Pathology, University of Western Australia, Perth, Australia

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2005 Oct 01;87(10):2202-2210. doi: 10.2106/JBJS.D.03049

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Abstract

Background: There is a lack of consensus regarding the best option for the treatment of acute Achilles tendon rupture. Treatment can be broadly classified as operative (open or percutaneous) or nonoperative (casting or functional bracing). Postoperative splinting can be performed with a rigid cast (proximal or distal to the knee) or a more mobile functional brace. The aim of this meta-analysis was to identify and summarize the evidence from randomized, controlled trials on the effectiveness of different interventions for the treatment of acute Achilles tendon ruptures.

Methods: We searched multiple databases (including EMBASE, CINAHL, and MEDLINE) as well as reference lists of articles and contacted authors. Keywords included Achilles tendon, rupture, and tendon injuries. Three reviewers extracted data and independently assessed trial quality with use of a ten-item scale.

Results: Twelve trials involving 800 patients were included. There was a variable level of methodological rigor and reporting of outcomes. Open operative treatment was associated with a lower risk of rerupture compared with nonoperative treatment (relative risk, 0.27; 95% confidence interval, 0.11 to 0.64). However, it was associated with a higher risk of other complications, including infection, adhesions, and disturbed skin sensibility (relative risk, 10.60; 95% confidence interval, 4.82 to 23.28). Percutaneous repair was associated with a lower complication rate compared with open operative repair (relative risk, 2.84; 95% confidence interval, 1.06 to 7.62). Patients who had been managed with a functional brace postoperatively (allowing for early mobilization) had a lower complication rate compared with those who had been managed with a cast (relative risk, 1.88; 95% confidence interval, 1.27 to 2.76). Because of the small number of patients involved, no definitive conclusions could be made regarding different nonoperative treatment regimens.

Conclusions: Open operative treatment of acute Achilles tendon ruptures significantly reduces the risk of rerupture compared with nonoperative treatment, but operative treatment is associated with a significantly higher risk of other complications. Operative risks may be reduced by performing surgery percutaneously. Postoperative splinting with use of a functional brace reduces the overall complication rate.

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

Figures in this Article

The Achilles tendon, which is formed by the merging of the tendons of the gastrocnemius and soleus, is the thickest and strongest tendon in the human body. Acute ruptures occur most commonly in men in the third and fourth decades of life who participate in sports intermittently, and the left side is ruptured more commonly than is the right side¹. The mechanisms of injury include sudden forced plantar flexion of the foot, unexpected dorsiflexion of the foot, and violent dorsiflexion of a plantar flexed foot². The prevalence is approximately 18 per 100,000 per year (in Finland) and is thought to be rising³.

It is generally accepted that ruptures occur in previously abnormal tendons^2,4. A number of etiological theories have been proposed, including the adverse influence of oral and topical corticosteroids^5,6, fluoroquinolone antibiotics (e.g., ciprofloxacin)⁷, exercise-induced hyperthermia⁸, and mechanical abnormalities of the foot⁹.

Treatment of acute Achilles tendon ruptures can be broadly classified as operative (open or percutaneous) or non-operative (cast immobilization or functional bracing). Generally, open operative treatment has been used for athletes and young, fit patients; percutaneous operative treatment has been used for those who do not wish to have an open repair (e.g., for cosmetic reasons); and nonoperative treatment has been used for the elderly^10-13.

Previous reviews have examined the relative advantages of operative and nonoperative treatment^14-17. However, to our knowledge, there has not been a systematic review of different methods of nonoperative treatment, operative treatment, and postoperative splinting. The aim of the present meta-analysis was to identify and summarize the evidence from randomized, controlled trials on the effectiveness of all treatment interventions for acute Achilles tendon ruptures.

Materials and Methods

Materials and Methods | Results | Discussion | Appendix | References

All randomized, controlled trials comparing operative and nonoperative methods for the treatment of acute Achilles tendon ruptures were considered for inclusion. Quasi-randomized trials (for example, those involving allocation by alternation or the date of birth) and trials in which the treatment allocation was inadequately concealed were also considered. We searched the Cochrane Musculoskeletal Injuries Group specialized register, reference lists of articles, and proceedings of relevant conferences, and we contacted authors when additional clarification was required. This register is compiled from multiple databases and includes the results of regular searches of the Cochrane Central Register of Controlled Trials in the Cochrane Library, MEDLINE (which combines subject-specific terms with the optimal trial search strategy¹⁸), EMBASE, CINAHL, and manual search results. In MEDLINE (OVID-WEB), the following subject-specific search was combined with all three levels of the optimal trial search strategy¹⁸: Achilles Tendon, (achill#s or tendoachill#s).tw., or/1-2, Rupture/, rupture$.tw., or/4-5, and/3,6, Tendon Injuries/, and/3,8, or/7,9. Articles in all languages were considered for inclusion and were translated when necessary. We excluded retrospective studies, studies with insufficient reporting of primary outcomes, studies with inadequate methods of randomization, and unique randomized, controlled trials (where pooling of data was not possible, making them unsuitable for meta-analysis).

Participants included adults with acute ruptures of the Achilles tendon. Patients with delayed presentation (more than three weeks after the injury) and rerupture were excluded. The types of interventions included operative repair (open and percutaneous) and nonoperative treatment (cast immobilization and functional bracing). The primary outcomes were complications of treatment and rerupture. Other outcomes, such as the level of sporting activity, patient satisfaction, and the length of hospital stay, were omitted because they lack quantity and uniformity to support rigorous meta-analysis.

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Fig. 1: System used for the scoring of methodology.

Trials were independently assessed for inclusion by four reviewers (R.J.K.K., D.F., A.K., and T.B.). Data on the outcomes listed above were extracted by three reviewers (R.J.K.K., D.F., and T.B.). Differences were resolved by discussion. Ten aspects of methodology were used to assign a maximum score of 12 to each study, similar to the scale described by Detsky et al.¹⁹ (Fig. 1). In addition, the risk of pre-allocation disclosure of assignment was rated as A, B, or C according to the Cochrane Reviewers' Handbook²⁰.

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Fig. 2: Flowchart depicting the method by which the twelve randomized, controlled studies were chosen.

For each study, relative risks and 95% confidence intervals were calculated for dichotomous outcomes, and weighted mean differences and 95% confidence intervals were calculated for continuous outcomes. The results of individually randomized trials were pooled whenever possible with use of the fixed-effects model of Mantel-Haenszel. Heterogeneity between comparable studies was tested with the use of a standard chisquare test. The random-effects model of DerSimonian and Laird was used when there was statistical or graphical evidence of heterogeneity.

Results

Materials and Methods | Results | Discussion | Appendix | References

Thirty-six articles were identified with use of our search strategy; of these, twenty-four were excluded from the meta-analysis (Fig. 2).

Details on the twelve randomized, controlled trials that were included in the review are documented in the Appendix. A total of 800 patients were involved. Four studies, involving 356 patients, compared open operative treatment with non-operative treatment^21-24. Five studies, involving 273 patients, compared postoperative splinting in a cast alone (i.e., rigid) with splinting in a cast followed by a functional brace (i.e., semi-mobile)^25-29. Two studies, involving ninety-four patients, compared percutaneous repair with open operative repair^24,30. Two studies, involving ninety patients, compared different nonoperative treatment regimens^31,32. The group of thirteen patients managed with open operative treatment as described by Schroeder et al.²⁴ were analyzed in two sections of the present review, which accounts for the discrepancy in the overall number of patients and studies involved.

The methodological quality scores of the included studies are detailed in Table I. Low scores indicate poor methodology.

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TABLE I Methodological Quality Scores

Study	Scores for Ten Items	Total Score (Maximum, 12)
Cetti et al.²¹	1110110010	6
Cetti et al.²⁵	1110010011	6
Kangas et al.²⁹	3110100111	9
Kerkhoffs et al.²⁶	0110110011	6
Lim et al.³⁰	0100010101	4
Maffulli et al.²⁸	0110111010	6
Moller et al.²²	3110110111	10
Mortensen et al.²⁷	2110110010	7
Nistor²³	0010010011	4
Petersen et al.³²	3110010010	7
Saleh et al.³¹	1100110011	6
Schroeder et al.²⁴	1100100000	3

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TABLE I Methodological Quality Scores

Study	Scores for Ten Items	Total Score (Maximum, 12)
Cetti et al.²¹	1110110010	6
Cetti et al.²⁵	1110010011	6
Kangas et al.²⁹	3110100111	9
Kerkhoffs et al.²⁶	0110110011	6
Lim et al.³⁰	0100010101	4
Maffulli et al.²⁸	0110111010	6
Moller et al.²²	3110110111	10
Mortensen et al.²⁷	2110110010	7
Nistor²³	0010010011	4
Petersen et al.³²	3110010010	7
Saleh et al.³¹	1100110011	6
Schroeder et al.²⁴	1100100000	3

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Fig. 3: Illustration indicating the prevalence of rerupture associated with open operative and nonoperative treatment. The values are given as the number of patients with a rerupture (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

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Fig. 4: Illustration indicating the prevalence of complications other than rerupture associated with open operative and nonoperative treatment. The values are given as the number of patients with a complication (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

Open Operative Treatment Compared with Nonoperative Treatment21-24

The rate of rerupture is summarized in Figure 3. One study²² revealed a significant difference between the operative group and the nonoperative group with regard to the rate of rerupture (one of fifty-nine compared with eleven of fifty-three; p = 0.0013). Of the three remaining studies, one showed no difference between operative and nonoperative treatment²¹, one included no reruptures²⁴, and one did not involve statistical analysis²³. Results gave a pooled rate of 3.5% (six of 173) in the operatively treated group and of 12.6% (twenty-three of 183) in the nonoperatively treated group (relative risk, 0.27; 95% confidence interval, 0.11 to 0.64). The mean duration of follow-up used for the calculation of rerupture rates ranged from eight to thirty months.

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Fig. 5: Illustration indicating the prevalence of wound infection associated with open operative and nonoperative treatment. The values are given as the number of patients with a wound infection (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

Nistor²³ and Moller et al.²² reported more adhesions, disturbed sensibility, and deep or superficial wound infection in the operative group. No statistical analysis was performed. Cetti et al.²¹ reported a significant increase in the rates of delayed wound-healing, adhesions, and disturbed sensibility in the operative group (p = 0.004). The pooled rate of reported complications (other than rerupture) was 34.1% (fifty-nine of 173) in the operative group and 2.7% (five of 183) in the nonoperative group (relative risk, 10.60; 95% confidence interval, 4.82 to 23.28). Similar analysis demonstrated an overall rate of wound infection of 4.0% (seven of 173) in the operative group; there were no infections in the nonoperative group (relative risk, 4.89; 95% confidence interval, 1.09 to 21.91). These results are summarized in Figures 4 and 5.

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Fig. 6: Illustration indicating the prevalence of rerupture associated with open surgery and percutaneous surgery. The values are given as the number of patients with a rerupture (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

Open Compared with Percutaneous Operative Repair24,30

Schroeder et al.²⁴ reported no reruptures, whereas Lim et al.³⁰ found no significant difference between the groups with regard to the rate of rerupture. The pooled rate of rerupture was 4.3% (two of forty-six) in the open group and 2.1% (one of forty-eight) in the percutaneous group (relative risk, 2.00; 95% confidence interval, 0.19 to 21.00). The mean duration of follow-up used for the calculation of the rerupture rates ranged from six to eight months. These results are summarized in Figure 6.

The pooled rate of reported complications (excluding rerupture) was 26.1% (twelve of forty-six) in the open group and 8.3% (four of forty-eight) in the percutaneous group (relative risk, 2.84; 95% confidence interval, 1.06 to 7.62). Lim et al. reported a significantly higher rate of wound infection in the open group as compared with the percutaneous group (p = 0.01)³⁰. The pooled rate of infection was 19.6% (nine of forty-six) in the open group and 0% (zero of forty-eight) in the percutaneous group (relative risk, 10.52; 95% confidence interval, 1.37 to 80.52). The results of these analyses are summarized in Figures 7 and 8.

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Fig. 7: Illustration indicating the prevalence of complications other than rerupture associated with open surgery and percutaneous surgery. The values are given as the number of patients with a complication (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

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Fig. 8: Illustration indicating the prevalence of wound infection associated with open surgery and percutaneous surgery. The values are given as the number of patients with an infection (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

Postoperative Splinting: Cast Immobilization Alone Compared with Cast Immobilization Followed by Functional Bracing25-29

Rerupture rates are summarized in Figure 9. No individual study demonstrated a significant difference between the groups. The pooled rate of rerupture was 5.0% (seven of 140) in the cast immobilization group and 2.3% (three of 133) in the functional bracing group (relative risk, 2.04; 95% confidence interval, 0.59 to 7.06). The mean duration of follow-up used for the calculation of the rerupture rates ranged from five months to 6.7 years.

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Fig. 9: Illustration indicating the prevalence of rerupture associated with postoperative splinting with casting alone and casting followed by functional bracing. The values are given as the number of patients with a rerupture (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

Complications were more common in the cast-only group; specifically, the cast-only group had higher rates of adhesions (18.6% compared with 9.7%), disturbed sensibility (8.6% compared with 3.8%), keloid or hypertrophic scarring (5% compared with 3%), and infection (3.5% compared with 3%). The pooled rate of reported complications (other than rerupture) was 35.7% (fifty of 140) in the cast immobilization group and 19.5% (twenty-six of 133) in the functional bracing group (relative risk, 1.88; 95% confidence interval, 1.27 to 2.76). The results are summarized in Figure 10.

Nonoperative Treatment: Casting Immobilization Compared with Functional Bracing31,32

Pooled data revealed a rerupture rate of 2.4% (one of forty-one) in the functional bracing group and of 12.2% (six of forty-nine) in the casting group (relative risk, 3.59; 95% confidence interval, 0.59 to 21.76). The mean duration of follow-up used for the calculation of the rerupture rates was twelve months for both studies. The results are summarized in Figure 11.

Discussion

Materials and Methods | Results | Discussion | Appendix | References

Twelve prospective randomized studies involving the treatment of acute Achilles tendon rupture fulfilled the inclusion criteria for this meta-analysis. Quality assessment scores were calculated for each study in order to assess the level of methodological rigor. They were not used as a criterion for exclusion or to weight the pooled data. However, the findings of studies with higher methodological quality should naturally be considered to be of greater importance. The scores indicate a variable level of methodological rigor, particularly with regard to the method of randomization and concealment of allocation. The quality of the primary study used for pooled analysis influences the results of a meta-analysis³³. The inclusion of poorly randomized trials can lead to over-reporting of treatment effect, and thus all recommendations should be critically appraised. Recommendations have been made on the basis of analysis of pooled data extracted from what were believed to be the most rigorously conducted studies.

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Fig. 10: Illustration indicating the prevalence of complications other than rerupture associated with postoperative splinting with casting alone and casting followed by functional bracing. The values are given as the number of patients with a complication (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

The rate of rerupture was consistently higher among nonoperatively treated patients as compared with operatively treated patients. The most methodologically sound study²² provided the most favorable rerupture rate with operative intervention, suggesting that there is a legitimate advantage associated with surgery. However, there was a consistent finding of increased rates of complications (other than rerupture) in the operatively treated group, with all studies demonstrating similar rates. In summary, nonoperatively treated patients have a more than three times higher risk of rerupture but have a minimal risk of other complications resulting from treatment. One-third of operatively treated patients have a complication.

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Fig. 11: Illustration indicating the prevalence of rerupture associated with nonoperative treatment (casting alone and casting followed by functional bracing). The values are given as the number of patients with a rerupture (n)/number of patients in the group (N), with a summation of the totals and the relative risk (RR) and 95% confidence intervals (95% CI).

A meta-analysis by Bhandari et al.¹⁵ comparing open operative treatment with nonoperative treatment of acute Achilles tendon ruptures did not provide a strong recommendation for surgery. The authors suggested that patients who are reluctant to undergo an operation may choose nonoperative treatment. Their meta-analysis included six studies, three of which were omitted from the present meta-analysis because of inadequate reporting of results³⁴, discontinuation of treatment in the control group because of a high recurrence rate and no allocation concealment (personal communication with the author)³⁵, and inadequate randomization³⁶. We included an extra study²⁴ that did fulfill our strict inclusion criteria. Nevertheless, the results reported by Bhandari et al.¹⁵ are similar to ours; specifically, the rerupture rate was 3.1% for operatively treated patients and 13% for nonoperatively treated patients (p = 0.005) and the infection rate was higher among operatively treated patients (4.7% compared with 0%; relative risk, 4.6; p = 0.03).

Lo et al.¹⁴ compiled two prospective trials and seventeen case series for their comparison of operative and nonoperative treatment. The studies by Moller et al.²² and Schroeder et al.²⁴ were not included in that analysis. Lo et al. found it difficult to recommend one treatment over the other on the basis of the combined complication rates¹⁴. They suggested that patients with poor healing potential should be managed nonoperatively and that active patients should be offered both operative and nonoperative treatment. In other reviews, Lynch¹⁶ and Wong et al.¹⁷ included sixteen studies and 125 studies, respectively. Both groups of investigators included nonrandomized trials in their analysis. The studies concurred in their recommendation for surgical intervention combined with early functional mobilization for the treatment of acute Achilles tendon ruptures; nonoperative management with early functional mobilization may be an acceptable alternative for patients who are reluctant to undergo a surgical procedure. Using a technique of analysis not previously applied to rupture of the Achilles tendon, Kocher et al.³⁷ performed an expected-value decision analysis of operative and nonoperative management. Expected-value decision analysis involves allocating utility scores to outcomes and allows quantitative analysis of decision-making. A decision tree was constructed, and prospective patients progressed through the various alternatives. Article selection for the generation of outcome probabilities followed the criteria of Lo et al.¹⁴. With use of this technique, operative treatment was found to be the optimal strategy. However, the authors stressed that the decision-making process should be shared between doctor and patient.

In our analysis of studies comparing open and percutaneous repair, we noted a tendency for a lower overall rate of complications (particularly infection) in the percutaneously treated group. However, this finding is based on pooled data from a small number of patients, and there is some discrepancy between studies with regard to the rate of infection in the open treatment group. In a previous review of prospective and retrospective studies regarding operative and nonoperative treatment, Wong et al.¹⁷ reported a lower rate of wound complications in patients undergoing percutaneous repair. However, they also noted that patients in the percutaneous group had relatively high rates of complications (notably sural nerve injury), particularly when the procedure was combined with early active mobilization.

One of the most important aspects of the present review is that pertaining to postoperative splintage. This subject has not been previously evaluated with use of meta-analysis. The functional bracing group had a significantly lower rate of complications (p = 0.001), particularly with regard to adhesion formation. The early mobilization group also tended to have a lower rerupture rate. Conclusions made on the basis of the pooled data must be interpreted with caution because of the variety of regimens used.

Limited conclusions can be drawn from the two studies comparing nonoperative treatment in a cast and functional bracing because of the small numbers involved (ninety patients), differences in regimens, and minimal reporting of outcomes^31,32. It is interesting to note, however, that the pooled rate of rerupture in the functional bracing group (2.4%) was lower than that for patients managed with operative treatment (3.5%). Indeed, it was almost equivalent to that seen for patients managed with immobilization in a functional brace after open repair (2.3%). This apparent discrepancy may be explained by the small numbers of patients managed nonoperatively.

In conclusion, open operative treatment of acute Achilles tendon ruptures significantly reduces the risk of rerupture compared with nonoperative treatment but has the drawback of a significantly higher risk of other complications, including wound infection. Complications may be reduced by performing surgery percutaneously. Postoperative splinting in a cast followed by a functional brace rather than a cast alone reduces the overall complication rate.

Additional rigorously conducted prospective randomized trials with larger sample sizes, full reporting of outcomes, and blinding of assessors are required. Increased transparency is needed if the same cohort of patients is reported on in different studies, and avoidance of multiple publications is strongly recommended.

Appendix

Materials and Methods | Results | Discussion | Appendix | References

A table presenting the characteristics of the included studies is available with the electronic versions of this article, on our web site at (go to the article citation and click on "Supplementary Material") and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM). ?

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Topics

achilles tendon ; casts, surgical ; immobilization ; rupture ; infection ; braces ; splint device

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Angus R. Keogh, MBBS

Posted on February 22, 2006

Re: Non-operative treatment of Achilles Tendon Ruptures

Department of Surgery and Pathology, University of Western Australia

We thank Dr. Levin for his encouraging comments. We agree entirely that it would be optimal to have all of the incorporated studies comparing the same non-operative and operative protocols. This is not always possible as there is a wide variation in treatment protocol from centre to centre. However, the figures of the article clearly show statistical homogeneity between studies comparing operative and non-operative treatments and there is a consistent trend towards lower re-rupture rate with operative treatment. Likewise, there is a consistent finding of increased complication rate in the operative group (confidence intervals overlap in all studies). Hence, we disagree that heterogeneity of the method of non-operative or operative treatment substantially compromises the validity and applicability of the conclusions. Statistical heterogeneity can result from treatment diversity but does not necessarily mean that the true treatment effect varies (i.e. every treatment has minor variations, yet the overall effect may be the same).

We agree with Dr. Levinâ€™s method of conservative treatment of Achilles tendon ruptures. This treatment naturally will lead to a rate of re- rupture which, from the meta-analysis, will be greater than that of operative treatment. This rate of rupture is consistent across the three studies examined. The most methodologically sound study(1) showed the greatest benefit.

When a large study directly comparing operative and non-operative treatment is not available it is accepted that meta-analysis is a sound alternative. We agree that a large trial directly comparing treatments would be optimal. However, obtaining a large series of patients with ruptured Achilles tendons, all undergoing the same treatment within a single centre would be difficult.

References:

1. Moller M, Movin T, Granhed H. Lind K, Faxen E, Karlsson J. Acute rupture of tendon Achillis. A prospective randomised study of comparison between surgical and non-surgical treatment. J Bone Joint Surg Br. 2001;83:843-8.

Riaz J.K. Khan, FRCS (Tr&Orth)

Posted on February 15, 2006

Treatment of Acute Achilles Tendon Ruptures

1/14-16 Hamersley Street, Cottesloe WA 6011, AUSTRALIA

To The Editor:

Our article â€œTreatment of Acute Achilles Tendon Ruptures. A Meta- Analysis of Randomized, Controlled Trialsâ€ (2005;87:2202-10), by Khan et al., was based on a review that was originally published as a Cochrane Review in the Cochrane Library.(1)

It has been brought to my attention that the article was published in the American JBJS without appropriate permission from John Wiley and Sons or acknowledgement of the Cochrane Library. We would like to apologize to both journals and to their readers for this lack of foresight.

Reference:

1. The Cochrane Database of Systematic Reviews, Issue 3, 2004. Chichester, UK: John Wiley and Sons.

Riaz J.K. Khan, FRCS(Tr&Orth) 1/14-16 Hamersley Street Cottesloe WA 6011 Australia

Riaz, J.K. Khan

Posted on December 13, 2005

Dr. Khan et al respond to Drs. Dobson and Nguyen

University of Western Australia

We thank Drs. Dobson and Nguyen for their letter. The issue they raise is one of semantics. Randomized trials (RCTs) may be blinded (eg with random numbers or sealed identical envelopes) or quasi -randomized (eg by alternation or odd/even numbers). Therefore we believe that our title is not misleading. Moreover, inclusion of such studies is accepted protocol for other evidence-based organisations such as Cochrane.

We have been explicit about inclusion criteria in the methodology section of our paper, stating that we would consider quasi-RCTs and those with inadequate concealment of treatment allocation. We have also been transparent and classified the randomization type in the results section (characteristics of included studies).

It would be ideal to include only pure randomized trials in a meta -analysis. However, in surgery, and orthopaedics in particular, there are regrettably, few such studies. Therefore, to exclude quasi-RCTs would reduce the numbers substantially. Like other researchers, we hope that the number of quasi-randomized trials will continue to decline as researchers use a blinded pure method of randomization.

Riaz J.K.Khan, Martyn Parker, Daniel Fick, Angus Keogh

Paul E. Levin

Posted on December 08, 2005

Non-operative treatment of Achilles Tendon Ruptures

Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY

To The Editor:

I applaud the attempt by Khan, et al to evaluate various treatments of acute achilles tendon ruptures. Unfortunately, the wide variability in conservative (non- operative) protocols in this meta-analysis substantially compromises the validity and applicability of the conclusions.(1-7).

The non-operative protocols include a number of different approaches: immobilization in short leg casts; long leg casts; and immediate functional bracing. In addition the periods of active treatment vary substantially. As a result, the meta-analysis is not truly comparing operative and non-operative treatments.

I have successfully treated Achilles tendon ruptures non-operatively with a protocol of a non weight bearing long leg cast for four weeks followed by four weeks of a short leg equinus weight bearing cast and an additional four weeks of functional bracing with a dorsiflexion stop.

Ultimately, an analysis of the optimal way to treat Achilles tendon ruptures will have to compare a strict protocol for both operative and non-operative approaches.

Paul E. Levin, M.D. Vice-chairman, Department of Orthopaedic Surgery Montefiore Medical Center, Bronx, NY

References:

1. Bhandari M, Guyatt G, Siddiqui F, Morrow F, Busse, J, Leighton R, Sprague S, Schemitsch E. Treatment of acute Achilles tendon ruptures a systematic overview and metaanalysis. Clin Orthop. 2002;400:190-200.

2. Blake R, Ferguson H. Achilles Tendon Rupture: a protocol for conservative management. JAPMA. 1991;81:486-489.

3. Edna T. Non-operative treatment of Achilles tendon ruptures. Acta orthop scand. 1980;51:991-993

4. Kocher MS, Bishop J, Marshall R, Briggs K, Hawkins R. Operative versus nonoperative management of acute Achilles tendon rupture. Am J Sports Med. 2002;30:783-788.

5. Lea R, Smith, L. Non-surgical treatment of tendo achiilis rupture. J Bone Joint Surg. 1972;54-A:1398-1407.

6. Nistor L. surgical and non-surgical treatment of Achilles tendon rupture. J Bone Joint Surg. 1981;63-A:394-399.

7. Weber M, Niemann M, Laz R, Muller T. Nonoperative treatement and comparison with operative treatment. Am J Sports Med. 2003;31:685-691.

Michael H. Dobson

Posted on November 17, 2005

Inclusion of Poorly Randomized Studies into Meta-Analysis

Whittington Hospital, London, ENGLAND

To The Editor:

We read with interest the article by Khan, et al, (1) entitled "Treatment of Acute Achilles Tendon Ruptures - A Meta-Analysis of Randomized, Controlled Trials" and we have some concerns regarding the papers that they included in the meta-analysis. The article states that its intention is to provide a meta- analysis of randomized, controlled trials; the authors clearly state their selection criteria and methodology scoring system.

However, we found that four papers (2,3,4,5) scored 0 for method of randomization and were thus recognised to be poorly randomized, if randomized at all. On our review of these papers, we noted that Kerkhoff, et al, (2) clearly state their study was only quasi-randomized and the study by Maffulli, et al, (3) was not randomized for patient selection; treatment selection was only quasi- randomized on the basis of day of attendance.

We feel that the inclusion of these papers into the meta-analysis may invalidate the results as they do not conform to the aims of the article-- a meta-analysis of RANDOMIZED, controlled trials. We would be interested in the reasons the authors have for including these papers in their meta-analysis.

REFERENCES:

1) Khan RJK, Fick D, Keogh A, Crawford J, Brammar T, Parker M. Treatment of acute Achilles tendon ruptures - a meta-analysis of randomized, controlled trials. J Bone Joint Surg.2005;87:2202-10

2) Kerkhoffs GM, Struijs PA, Raaymakers EL, Marti RK. Functional treatment after surgical repair of acute Achilles tendon rupture:wrap vs walking cast. Arch Orthop Trauma Surg.2002;122:102-5

3)Maffulli N, Tallon C, Wong J, Lim KP, Bleakney R. Early weightbearing and ankle mobilization after open repair of acute midsubstance tears of the achilles tendon. Am J Sports Med.2003;31:692-700

4) Lim J, Dalal R, Waseem M. Percutaneous vs. open repair of the ruptured Achilles tendon-a prospective randomized controlled study. Foot Ankle Int.2001;22:559-568

5) Nistor l, Surgical and non-surgical treatment of Achilles tendon rupture. a prospective randomized study. J Bone Joint Surg Am.1981;63:394- 9

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Riaz J.K. Khan, Dan Fick, Angus Keogh, John Crawford, Tim Brammar, Martyn Parker; Treatment of Acute Achilles Tendon RupturesA Meta-Analysis of Randomized, Controlled Trials. The Journal of Bone & Joint Surgery. 2005 Oct;87(10):2202-2210.

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