This is an enhanced PDF from The Journal of Bone and Joint Surgery The PDF of the article you requested follows this cover page. Treatment of Acute Achilles Tendon Ruptures. A Meta-Analysis of Randomized, Controlled Trials Riaz J.K. Khan, Dan Fick, Angus Keogh, John Crawford, Tim Brammar and Martyn Parker J Bone Joint Surg Am. 2005;87:2202-2210. doi:10.2106/JBJS.D.03049 This information is current as of September 22, 2008 Supplementary material Commentary and Perspective, data tables, additional images, video clips and/or translated abstracts are available for this article. This information can be accessed at http://www.ejbjs.org/cgi/content/full/87/10/2202/DC1 Letters to The Editor are available at http://www.ejbjs.org/cgi/content/full/87/10/2202#responses Reprints and Permissions Click here to order reprints or request permission to use material from this article, or locate the article citation on jbjs.org and click on the [Reprints and Permissions] link. Publisher Information The Journal of Bone and Joint Surgery 20 Pickering Street, Needham, MA 02492-3157 www.jbjs.org 2202 COPYRIGHT © 2005 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED Treatment of Acute Achilles Tendon Ruptures A META-ANALYSIS OF RANDOMIZED, CONTROLLED TRIALS BY RIAZ J.K. KHAN, FRCS(TR&ORTH), DAN FICK, MBBS, ANGUS KEOGH, MBBS, JOHN CRAWFORD, FRCS(TR&ORTH), TIM BRAMMAR, FRCS(TR&ORTH), AND MARTYN PARKER, MD Investigation performed at Perth Orthopaedic Institute, Department of Surgery and Pathology, University of Western Australia, Perth, Australia 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. T he 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 tendons2,4. A number of etiological theories have been proposed, including the adverse influence of oral and topical corticosteroids5,6, 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 nonoperative (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 elderly10-13. Previous reviews have examined the relative advantages of operative and nonoperative treatment14-17. However, to our knowledge, there has not been a systematic review of different 2203 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 10 · O C T O B E R 2005 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 ll 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, A Fig. 1 System used for the scoring of methodology. TRE A T M E N T O F A C U T E A C H I L L E S TE N D O N R U P T U RE S 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. 2204 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 10 · O C T O B E R 2005 TRE A T M E N T O F A C U T E A C H I L L E S TE N D O N R U P T U RE S Fig. 2 Flowchart depicting the method by which the twelve randomized, controlled studies were chosen. 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. 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 fixedeffects 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 hirty-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 nonoperative treatment21-24. 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., T semi-mobile)25-29. Two studies, involving ninety-four patients, compared percutaneous repair with open operative repair24,30. Two studies, involving ninety patients, compared different nonoperative treatment regimens31,32. 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. TABLE I Methodological Quality Scores Scores for Ten Items Total Score (Maximum, 12) Cetti et al.21 1110110010 6 Cetti et al.25 1110010011 6 3110100111 9 0110110011 6 0100010101 4 0110111010 6 3110110111 10 2110110010 7 0010010011 4 3110010010 7 Saleh et al. 1100110011 6 Schroeder et al.24 1100100000 3 Study Kangas et al. 29 Kerkhoffs et al.26 Lim et al. 30 Maffulli et al.28 Moller et al. 22 Mortensen et al.27 Nistor 23 Petersen et al.32 31 2205 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 10 · O C T O B E R 2005 TRE A T M E N T O F A C U T E A C H I L L E S TE N D O N R U P T U RE S 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). 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 followup used for the calculation of rerupture rates ranged from eight to thirty months. 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 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). 2206 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 10 · O C T O B E R 2005 TRE A T M E N T O F A C U T E A C H I L L E S TE N D O N R U P T U RE S 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). 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. 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 fortysix) 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. 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). 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). 2207 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 10 · O C T O B E R 2005 TRE A T M E N T O F A C U T E A C H I L L E S TE N D O N R U P T U RE S 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). 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. 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 inter- val, 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 welve 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. 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 interven- T 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). 2208 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 10 · O C T O B E R 2005 TRE A T M E N T O F A C U T E A C H I L L E S TE N D O N R U P T U RE S 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). tion, 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. 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 decisionmaking 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 outcomes31,32. 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 2209 THE JOUR NAL OF BONE & JOINT SURGER Y · JBJS.ORG VO L U M E 87-A · N U M B E R 10 · O C T O B E R 2005 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 A table presenting the characteristics of the included studies is available with the electronic versions of this article, on our web site at jbjs.org (go to the article citation and click on “Supplementary Material”) and on our quarterly CDROM (call our subscription department, at 781-449-9780, to order the CD-ROM). TRE A T M E N T O F A C U T E A C H I L L E S TE N D O N R U P T U RE S Riaz J.K. Khan, FRCS(Tr&Orth) Department of Orthopaedics, Norfolk and Norwich University Hospital, Colney Lane, Norwich, Norfolk, NR4 7UY, United Kingdom. E-mail address: [email protected] Dan Fick, MBBS Angus Keogh, MBBS Department of Surgery and Pathology, University of Western Australia, Perth, WA 6009, Australia John Crawford, FRCS(Tr&Orth) Tim Brammar, FRCS(Tr&Orth) Addenbrooke’s Hospital, Cambridge, CB2 2QQ, United Kingdom Martyn Parker, MD Peterborough District Hospital, Peterborough, PE3 6DA, United Kingdom 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. doi:10.2106/JBJS.D.03049 References 1. Hattrup SJ, Johnson KA. A review of ruptures of the Achilles tendon. Foot Ankle. 1985;6:34-8. 16. Lynch RM. 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