The American Journal of Sports Medicine http://ajs.sagepub.com/ Stable Surgical Repair With Accelerated Rehabilitation Versus Nonsurgical Treatment for Acute Achilles Tendon Ruptures: A Randomized Controlled Study Nicklas Olsson, Karin Grävare Silbernagel, Bengt I. Eriksson, Mikael Sansone, Annelie Brorsson, Katarina Nilsson-Helander and Jón Karlsson Am J Sports Med 2013 41: 2867 originally published online September 6, 2013 DOI: 10.1177/0363546513503282 The online version of this article can be found at: http://ajs.sagepub.com/content/41/12/2867 Published by: http://www.sagepublications.com On behalf of: American Orthopaedic Society for Sports Medicine Additional services and information for The American Journal of Sports Medicine can be found at: Email Alerts: http://ajs.sagepub.com/cgi/alerts Subscriptions: http://ajs.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav >> Version of Record - Nov 27, 2013 OnlineFirst Version of Record - Sep 6, 2013 What is This? Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 Stable Surgical Repair With Accelerated Rehabilitation Versus Nonsurgical Treatment for Acute Achilles Tendon Ruptures A Randomized Controlled Study Nicklas Olsson,*y MD, PhD, Karin Grävare Silbernagel,z PT, ATC, PhD, Bengt I. Eriksson,y MD, PhD, Mikael Sansone,y MD, Annelie Brorsson,y PT, MSc, Katarina Nilsson-Helander,§ MD, PhD, and Jón Karlsson,y MD, PhD Investigation performed at the Institute of Clinical Sciences at Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Mölndal, Sweden Background: The optimal treatment for acute Achilles tendon ruptures is still a subject of debate. Early loading of the tendon is a factor that has been shown to be beneficial to recovery and to minimize complications. The main outcome of previous studies has been complications such as reruptures and deep infections, without focusing on the functional outcome relevant to the majority of patients who do not experience these complications. Purpose: To evaluate whether stable surgical repair and early loading of the tendon could improve patient-reported outcome and function after an acute Achilles tendon rupture. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 100 patients (86 men, 14 women; mean age, 40 years) with an acute total Achilles tendon rupture were randomized to either surgical treatment, including an accelerated rehabilitation protocol, or nonsurgical treatment. The primary outcome was the Achilles tendon Total Rupture Score (ATRS). The patients were evaluated at 3, 6, and 12 months for symptoms, physical activity level, and function. Results: There were no significant differences between the groups in terms of symptoms, physical activity level, or quality of life. There was a trend toward improved function in surgically treated patients; the results were significantly superior when assessed by the drop countermovement jump (95% CI, 0.03-0.15; P = .003) and hopping (95% CI, 0.01-0.33; P = .040). No reruptures occurred in the surgical group, while there were 5 in the nonsurgical group (P = .06). There were 6 superficial infections in the surgically treated group; however, these superficial infections had no bearing on the final outcome. Symptoms, reduced quality of life, and functional deficits still existed 12 months after injury on the injured side in both groups. Conclusion: The results of the present study demonstrate that stable surgical repair with accelerated tendon loading could be performed in all (n = 49) patients without reruptures and major soft tissue–related complications. However, this treatment was not significantly superior to nonsurgical treatment in terms of functional results, physical activity, or quality of life. Keywords: Achilles tendon rupture; Achilles tendon Total Rupture Score; ATRS; functional evaluation; rerupture; heel-rise test; physical activity level; Foot and Ankle Outcome Score; FAOS; EQ-5D versus immobilization. Recent studies have shown that major functional deficits exist after an acute Achilles tendon rupture, with a wide variation between patients.4,25,28,33,47 These deficits appear to be similar irrespective of the selected treatment.4,25,33,47 Patients can expect a year-long recovery after an Achilles tendon rupture, and many patients do not achieve full recovery of strength and function despite extensive rehabilitation. During the past few years, there has been a shift toward more accelerated rehabilitation and early weightbearing, which appear to produce There are several alternatives when it comes to the treatment of acute Achilles tendon ruptures, but no consensus exists regarding the optimal treatment protocol. An Achilles tendon rupture can be treated surgically or nonsurgically, with different alternatives in terms of mobilization The American Journal of Sports Medicine, Vol. 41, No. 12 DOI: 10.1177/0363546513503282 Ó 2013 The Author(s) 2867 Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 2868 Olsson et al The American Journal of Sports Medicine improved results.23,42,45 These favorable results related to early mobilization have recently been shown to be independent of surgical or nonsurgical treatment.9,29,45,47 In previous studies,3,19 the success of a treatment has been measured by the ability to minimize the risk of reruptures and other serious complications. The rerupture rate is also the primary outcome variable in 2 recently published randomized controlled trials.29,47 Systematic reviews and meta-analyses of randomized controlled trials report rerupture rates of approximately 3% to 4% after surgical treatment and 10% to 13% after nonsurgical treatment.3,14,19 In more recent studies, these rates (0%-7%) are, however, lower.2,13,42,47 With current treatment protocols, rerupture rates are fairly low (with both surgical and nonsurgical treatments), but many patients still fail to achieve full recovery. For this reason, there is a rationale for a shift toward fully restored function with minimal symptoms as the main goal, and functional variables and patient-reported outcome measurements might therefore be more appropriate as the primary outcome. Early loading of the tendon and early mobilization of the patient have been shown to be beneficial to recovery.9,24,29,42,45,47 However, most study protocols do not initiate immediate weightbearing or exercises of the ankle until after 4 to 8 weeks.17,29,45,47 Based on current preclinical studies, mechanical loading appears to be beneficial during the early stages of tendon healing.1,10,20 To achieve early accelerated tendon loading, we believe that both early weightbearing and early mobilization of the ankle and Achilles tendon are needed. A flexor tendon rupture in the hand is currently primarily repaired with stable end-to-end sutures that are able to tolerate immediate controlled mobilization.22 If this type of suture technique is used in the repair of the Achilles tendon, this might allow for the immediate mobilization of this tendon as well. There is no consensus with regard to the optimal suture technique in the open repair of acute Achilles tendon ruptures, even though the Bunnell, Krackow locking loop, and Kessler techniques are the most frequently reported.48 The Krackow locking loop technique has superior strength according to some studies,46,48 while the Bunnell and Kessler techniques show similar results in another study.46 When the suture technique in the present study was selected, we preferred a technique with high resistance to tensile strength that could be generally performed by orthopaedic surgeons. We decided to use a technique including both a core suture with a modified Kessler technique and an epitendinous cross-stitch, as described by Silfverskiold and Andersson41 in a modified manner, with a double Kessler technique as a core suture, as recommended by Shaieb and Singer36 for flexor tendon injuries in the hand. The purpose of this study was therefore to evaluate whether early loading of the tendon and range of motion training could improve patient-reported outcome and function after a total acute Achilles tendon rupture. We hypothesized that patients treated with a stable surgical repair and early accelerated tendon loading and range of motion training would have superior results compared with nonsurgical treatment with more traditional rehabilitation after an acute Achilles tendon rupture. MATERIALS AND METHODS A total of 101 patients with an acute Achilles tendon rupture were included in this randomized controlled study between April 2009 and October 2010. This study was conducted at 1 center in Sweden. All patients (age, 18-65 years) with a closed midsubstance rupture, who attended this center, were included in the study. The diagnosis was based on medical history and clinical examination (a palpable gap and a positive Thompson test result44). Patients were excluded if the rupture was older than 4 days and if they had a prior Achilles tendon rupture (either side) or other injuries that affected their lower limb function. Neuromuscular disease, diabetes, peripheral vascular disease, immunosuppressive treatment including systemic cortisone, skin infection or wound, and inability to attend rehabilitation or evaluations were all exclusion criteria. All the patients were given oral and written information about the study before randomization. Of the 201 patients with an Achilles tendon rupture during this period, 101 patients met the inclusion/exclusion criteria and agreed to participate in the study (Figure 1). The patients were randomized directly after inclusion, and computer-generated opaque and sealed envelopes were used in the randomization process. The patients and the treating physician and physical therapists responsible for treatment and evaluations were not blinded to treatment group. One patient was initially included in the study despite having an ongoing skin infection and was therefore excluded from the study directly after randomization. This patient was randomized to surgical treatment. All patients gave their written informed consent to participate in the study. Ethical approval was obtained from the regional ethical review board in Sweden. Baseline characteristics of the patients are shown in Table 1. Treatment Procedure Surgical Group. Forty-nine patients were treated surgically by 1 of 10 experienced orthopaedic surgeons using the *Address correspondence to Nicklas Olsson, MD, PhD, Orthocenter IFK-Kliniken, Arvid Wallgrens Backe 4a, SE-413 46 Göteborg, Sweden (e-mail: nicklas.olsson@gu.se). y Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Mölndal, Sweden. z Department of Physical Therapy, University of the Sciences, Philadelphia, Pennsylvania. § Department of Orthopedics, Kungsbacka Hospital, Kungsbacka, Sweden. One or more of the authors has declared the following potential conflict of interest or source of funding: This study was supported by the Swedish National Center for Research in Sports. Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 Vol. 41, No. 12, 2013 Treatment for Acute Achilles Tendon Ruptures TABLE 1 Patient Baseline Characteristics 201 patients with Achilles tendon rupture Excluded based on study criteria (n=60) Surgical Group Variable Eligible for inclusion (n=141) Declined to participate (n=40) Wanted nonsurgical treatment (n=23) Wanted surgical treatment (n=10) Nonspecific reason (n=7) Randomized (n=101) Incorrect inclusion (n=1) Surgical (n=49) Nonsurgical (n=51) Partial rerupture (n=1) Lost to follow-up (n=1) Follow-up: 3 mo (n=47) Rerupture (n=4) Follow-up: 3 mo (n=47) Rerupture (n=1) Follow-up: 6 mo (n=47) Follow-up: 6 mo (n=46) Patients, n (%) Age, y Mean 6 SD Median (range) Sex, n (%) Male Female Height, cm Mean 6 SD Median (range) Weight, kg Mean 6 SD Median (range) Body mass index Mean 6 SD Median (range) Injured side, n (%) Right Left Smoker, n (%) Nonsmoker, n (%) Nonsurgical Group 49 (49) 51 (51) 39.8 6 8.9 40 (24-61) 39.5 6 9.7 39 (20-63) 39 (80) 10 (20) 47 (92) 4 (8) P Valuea .74 .09 .43 179 6 8.5 180 (164-200) 179 6 7.5 179 (160-195) 87.2 6 13.0 89 (55-110) 82.0 6 10.8 81 (63-112) .036 .037 27.1 6 3.5 26.2 (20-39) 25.7 6 2.8 25.7 (20-34) .10 25 24 4 45 (51) (49) (8) (92) 35 16 5 46 (69) (31) (10) (90) 1.00 a Boldface indicates significant difference. Lost to follow-up (n=1) Lost to follow-up (n=4) Follow-up: 12 mo (n=43) 2869 Follow-up: 12 mo (n=45) Figure 1. Flow diagram for the study. same standardized technique. Surgery was performed in all patients under local anesthesia. Prophylactic antibiotics (cloxacillin) and prophylaxis against deep vein thrombosis (dalteparin natrium) were given because of the high risk of deep venous thrombosis.32 Patients were operated on in the prone position without a tourniquet. A posteromedial skin incision was made over the rupture site, and the paratenon was then carefully identified before further incision. The tendon was repaired end to end using core suturing with 2 strong semiabsorbable sutures (No. 2 Orthocord, DePuy Mitek, Norwood, Massachusetts) and a modified Kessler technique.18 The double Kessler locking loop was carefully placed away from the rupture site and sutured in healthy tendon to achieve the greatest stability. The foot was placed in plantar flexion to close the gap in the tendon. Care was taken not to overtension the tendon with a maximum plantar flexion of 20° to suit the brace. A running circumferential suture was used with absorbable sutures (No. 0 Polysorb, Tyco, Norwalk, Connecticut), using an epitendinous cross-stitch technique described by Silfverskiold and Andersson41 to reinforce the core sutures (Figure 2). The paratenon was then carefully repaired with absorbable No. 3-0 Polysorb and continuous No. 2-0 Polysorb subcutaneous sutures. Interrupted nylon sutures were used in the skin layer to ensure meticulous wound closure. No cast was used, and the ankle was postoperatively immobilized in a pneumatic walker brace (Aircast XP Diabetic Walker, DJO, Vista, California), including 3 heel pads that produce a plantarflexion angle of approximately 22°. A soft 5-mm inner sole was used to compensate for the somewhat stiff heel pads. Patients were allowed full weightbearing, which was encouraged from the first postoperative day. Three experienced physical therapists supervised the postoperative care and rehabilitation of all the patients. Early active rehabilitation started 2 weeks postoperatively and included both range of motion and strength training following a standardized protocol (see Appendix 1, available online at http://ajsm.sagepub.com/supplemental). The surgical group was mobilized in the brace for 6 weeks. Nonsurgical Group. Fifty-one patients were included in the nonsurgical group. Treatment started immediately after randomization, using the same brace as in the surgical group, including the 3 heel pads. Full weightbearing was allowed and encouraged from the beginning in the same manner as for the surgical group. This treatment group used another standardized protocol (see Appendix 2, available online) and was immobilized in the brace for 8 weeks. A similar nonoperative treatment has previously been described by Ingvar et al.13 Follow-up Evaluation A clinical follow-up examination was performed at the orthopaedic department, primarily by the first author (N.O.), at 2, 6, and 26 weeks in the surgical group and at 8 and 26 weeks in the nonsurgical group. The focus Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 2870 Olsson et al The American Journal of Sports Medicine functional tests, patient-reported outcomes, and physical activity levels measured at 3, 6, and 12 months. Patient-Reported Outcome and Physical Activity Before functional testing, the patients answered 4 different questionnaires. These have been used in previous studies in this patient group and have been shown to be reliable and valid.11,12,31,34 To evaluate injury-specific patient-reported outcome, we used the ATRS.16,31 The ATRS ranges from 0 to 100; a lower score indicates greater limitations to physical activity and more symptoms. The Physical Activity Scale (PAS) questionnaire12 was used to evaluate the activity level. A score of 1 is equal to no physical activity, whereas a score of 6 equals heavy physical exercise several times a week. For a foot and ankle perspective, 3 subscales of the Foot and Ankle Outcome Score (FAOS)34 were used: activities of daily living (ADL), function in sport and recreation, and foot- and ankle-related quality of life (QOL). All the subscales of the FAOS range from 0 to 100. A score of 0 indicates a high degree of foot- and ankle-related symptoms, whereas 100 indicates no symptoms. General health-related quality of life was measured by the EuroQol Group’s questionnaire (EQ-5D).5,11 An EQ-5D score of 0 is considered to be the worst imaginable health state and a score of 1.00 the best imaginable health state. At the time of inclusion (baseline), the EQ-5D and PAS were assessed. During the follow-up at 3, 6, and 12 months, all the scores were used. Figure 2. Illustration of the suture technique used in the trial. Functional Evaluation at this time was to evaluate and register any clinical complications. If a rerupture occurred, the diagnosis was based on the clinical examination, evaluating whether there was a palpable tendon gap, loss of plantarflexion strength, and a positive Thompson test result. Magnetic resonance imaging (MRI) was used if the clinical examination was nonconclusive. Wound- and skinrelated disturbances and infections were diagnosed by clinical signs and, if suitable, microbiological samples. Nerve disturbances were diagnosed by case history and clinical examination in the event of a loss or partial loss of sensibility. The patients were evaluated using patient-reported outcomes and functional evaluation tests on 3 occasions at a mean 6 standard deviation (SD) of 12 6 0.7, 28 6 2.1, and 56 6 4.3 weeks by the same physical therapist at our testing laboratory. The evaluating physical therapist was not involved in the treatment of the patients. All patient-reported outcome data in this study were collected using a web-based protocol. This minimized the risk of missing values and lost data. Outcomes The primary outcome in this study was the Achilles tendon Total Rupture Score (ATRS).31 Secondary outcomes included reruptures and other complications as well as The functional evaluation protocol consisted of 2 different jump tests, 2 different strength tests, and 1 muscular endurance test, and the MuscleLab (Ergotest Technology, Oslo, Norway) measurement system was used for the evaluations. This testing protocol using the MuscleLab unit was performed exactly as previously described in the literature.29,38,39 The tests have been shown to be reliable and valid38,39 and have been used in evaluating outcome after Achilles tendon ruptures.29,30,39 All evaluations were performed by the same experienced physical therapist. All the patients were given standardized instructions and warm-up, and athletic footwear was standardized. The jump tests comprised a drop countermovement jump (drop CMJ) and hopping. For the drop CMJ, the patients started by standing on 1 leg, on a 20 cm–high box, then jumped down onto the floor, and directly afterward performed a maximum vertical jump.38 For data analysis, the maximum jumping height (in cm) was used. Hopping was a continuously rhythmic jump similar to skipping performed on 1 leg at a time.38 The mean hopping height (in cm) and the hopping quotient (flight time/ contact time) were used for data analysis. The strength tests were a concentric heel rise and an eccentric-concentric heel rise performed while standing on 1 leg in a weight machine.38 The best trial, that is, the trial with the highest power (in W), for each weight was used for data analysis. Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 Vol. 41, No. 12, 2013 Treatment for Acute Achilles Tendon Ruptures Muscular endurance was tested using a single-leg standing heel-rise test.39 This was performed on 1 leg at a time with the participant standing on a box with an incline of 10°. A metronome was used to maintain the frequency of 30 heel rises a minute. The participant was instructed to go as high as possible on each heel rise and was asked to perform as many as possible. The test was terminated when the patient stopped, was unable to maintain the frequency, or did not perform a proper heel rise (minimum height of 2 cm). The numbers of heel rises, as well as the height of each heel rise and the total work (body weight 3 total distance; in J), were used for data analysis. To document the heel-rise height, the maximum height obtained during the test was used for evaluation. Statistical Analysis Power calculations were based on data from a previous study in which the ATRS value at 12 months had an SD of 15.39 The effect size was set at 10, based on published data of a minimal detectable change of 6.8.6 The power was set at 85% and the type I error at 5%. Power analysis gave us a sample size of 41 in each group. The limb symmetry index (LSI) was defined as the ratio between the involved limb score and the uninvolved limb score, expressed as a percentage (involved/uninvolved 3 100 = LSI). Because the LSI represents the clinical relevance of the functional results, we used these data when comparing the 2 treatment groups. The absolute values are used when measuring the recovery of function in each group and also the comparison over time. All the data were analyzed using IBM SPSS Statistics (version 20.0, IBM Corp, Armonk, New York). For descriptive statistics, we report the questionnaire results as both median (range) and mean 6 SD. The reason for reporting the results in both ways is that, as these are ordinal data, we want to use the median (range), but as results based on these questionnaires are often reported as the mean 6 SD in other articles, we have included that as well. The level of significance was set at P \ .05. For this study, we used nonparametric statistics in the evaluation of the questionnaires. The MannWhitney U test was used to compare 2 groups of patients. The x2 test was used for dichotomous variables, and when the sample size was small, the Fisher exact test was used. The Wilcoxon signed-rank sum test was used to compare paired variables. An analysis of the functional data revealed normal distribution, and parametric statistics were therefore used when evaluating these data. The independent t test was used to compare the 2 groups, and to compare side-to-side differences, the paired t test was used. RESULTS Patient-Reported Outcome and Physical Activity The surgical group had a median ATRS of 44 (range, 11-86; mean, 43 6 20) at the 3-month evaluation, a median ATRS of 75 (range, 0-99; mean, 70 6 23) at the 6-month evaluation, and a median ATRS of 89 (range, 0-100; mean, 82 6 2871 20) at the 12-month evaluation. The nonsurgical group had a median ATRS of 33 (range, 6-73; mean, 35 6 14) at the 3-month evaluation, a median ATRS of 73 (range, 3397; mean, 70 6 19) at the 6-month evaluation, and a median ATRS of 90 (range, 2-100; mean, 80 6 23) at the 12-month evaluation. There were no statistically significant differences between the 2 treatment groups at 3, 6, and 12 months as evaluated by the ATRS, and both groups improved significantly over time (P \ .001) at the 3-, 6-, and 12-month evaluations (Table 2). The median preinjury PAS score was 4 (range, 2-6; mean, 3.9 6 1.1) in the surgical group and 4 (range, 2-6; mean, 4.2 6 1.0) in the nonsurgical group. There were no significant differences in physical activity level between the groups’ preinjury level or at 6 and 12 months (Table 2). Furthermore, no significant differences were found in physical activity level when comparing the preinjury level with the level at 12 months either in the surgical group (P = .78) or in the nonsurgical group (P = .23). At the 3-month evaluation, the median FAOS ADL subscores were 81 (range, 13-100; mean, 78 6 17) in the surgical group and 79 (range, 40-97; mean, 77 6 13) in the nonsurgical group, with no significant difference between the groups (P = .42). At the same time, the median FAOS sport and recreation subscore was 30 (range, 0-85; mean, 34 6 22) in the surgical group and 30 (range, 0-65; mean, 28 6 17) in the nonsurgical group, with no significant differences between the groups (P = .24). The FAOS ADL and FAOS sport and recreation subscores improved significantly (P \ .01) over time in both the surgical and nonsurgical groups at the 3-, 6-, and 12-month evaluations, except for the FAOS ADL subscore in the surgical group between 6 and 12 months (P = .10) (Table 2). Quality of Life The median FAOS QOL subscore was 44 (range, 0-81; mean, 45 6 18) at 3 months in the surgical group and 38 (range, 6-69; mean, 39 6 15) in the nonsurgical group, with no significant differences between the groups (P = .10). The FAOS QOL subscores at the 6- and 12-month evaluations are shown in Table 2. The scores improved significantly over time between 3, 6, and 12 months (P \ .001). The median preinjury level according to the EQ-5D was 1.00 (range, 0.52-1.00; mean, 0.95 6 0.11) in the surgical group and 1.00 (range, 0.26-1.00; mean, 0.95 6 0.13) in the nonsurgical group. At 12 months, the median EQ-5D value was 1.00 (range, 0-1.00; mean, 0.91 6 0.17) in the surgical group and 1.00 (range, 0.52-1.00; mean, 0.90 6 0.13) in the nonsurgical group (Table 2). There were no significant differences (P = .30) between the 2 treatment groups at the 12-month evaluation, but there was a significant decrease in the EQ-5D value in both the surgical (P = .03) and nonsurgical (P = .03) groups at the 12-month evaluation compared with the preinjury value. Functional Tests Surgical Versus Nonsurgical Group at 3, 6, and 12 Months. Table 3 shows the LSI values for the surgical Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 2872 Olsson et al The American Journal of Sports Medicine TABLE 2 Results of the 6- and 12-Month Postinjury Evaluationsa 6-Month Evaluation Surgical (n = 47) ATRS Mean 6 SD Median (range) FAOS ADL Mean 6 SD Median (range) FAOS sport and recreation Mean 6 SD Median (range) FAOS QOL Mean 6 SD Median (range) PAS Mean 6 SD Median (range) EQ-5D Mean 6 SD Median (range) Nonsurgical (n = 46) 12-Month Evaluation P Value Surgical (n = 43) Nonsurgical (n = 45) .63 70 6 23 75 (0-99) 70 6 19 73 (33-97) 90 6 17 96 (24-100) 92 6 10 96 (60-100) 68 6 24 70 (0-100) 69 6 19 70 (25-100) 63 6 20 63 (0-100) 61 6 16 63 (25-94) 3.8 6 1.0 4 (1-6) 3.8 6 1.1 3 (2-6) .68 82 6 20 89 (0-100) 80 6 23 90 (2-100) 94 6 14 99 (21-100) 94 6 11 100 (54-100) 83 6 20 90 (0-100) 83 6 21 90 (15-100) 75 6 21 75 (0-100) 77 6 21 81 (25-100) 4.0 6 1.1 4 (1-6) 4.0 6 1.0 4 (2-6) .59 .37 .83 .70 .54 .51 .59 .85 .24 0.88 6 0.18 1.00 (0.08-1.00) 0.86 6 0.13 0.82 (0.62-1.00) P Value .30 0.91 6 0.17 1.00 (0-1.00) 0.90 6 0.13 1.00 (0.52-1.00) a ADL, activities of daily living; ATRS, Achilles tendon Total Rupture Score (0-100); EQ-5D, EuroQol Group’s general health-related quality of life (0-1.00); FAOS, Foot and Ankle Outcome Score (0-100); PAS, Physical Activity Scale (1-6); QOL, foot- and ankle-related quality of life. and nonsurgical groups at the 6- and 12-month evaluations. The LSI values were consistently higher in the surgical group compared with the nonsurgical group, except for concentric and eccentric power at 6 months (Table 3), but these differences were nonsignificant, except for hopping and the drop CMJ at 12 months (Table 3). Injured Versus Uninjured Side. The recovery of function in both groups and each test variable is presented in absolute values in Appendix 3 (available online). A comparison of the injured with the uninjured side in Appendix 3 shows that all the values were significantly (P \ .001) higher on the uninjured side at 6 months. At 12 months, the injured side had improved in the surgical group, and there were no significant differences in hopping and concentric power when comparing the injured and uninjured sides (P = .24-.76). In the nonsurgical group, the injured side also improved in the hopping test, and there were no significant differences between the sides (P = .07-.08). Complications There were no reruptures in the surgical group. However, 1 surgically treated patient sustained a partial rerupture during a fall on level ground 3 weeks after the last day of immobilization. A clinical examination and MRI were used to diagnose this partial rerupture. The tendon healed after additional treatment with 8 weeks in a brace. This long time in a brace was mainly because the patient was highly noncompliant with the mobilization instructions. Five patients (10%) in the non–surgically treated group sustained a rerupture, all of which occurred between 5 and 12 weeks after the initial injury. One patient was noncompliant during the brace treatment, 1 patient sustained a rerupture when walking on level ground, 1 patient had a new trauma during a fall from stairs, 1 patient had a rerupture at the functional evaluation during the heelrise test at 12 weeks, and the last patient had clinical signs of a nonhealed tendon (palpable gap and positive Thompson test result) at the end of immobilization. All 5 patients were surgically treated with augmentation as previously described by Nilsson-Helander et al,30 and the diagnosis was confirmed during surgery. There was a numerical difference in the rerupture incidence between the 2 treatment groups (P = .06). The patients who sustained a rerupture were all tested at 6 and 12 months after the rerupture (see Appendix 4, available online) using the same test protocol as those who did not sustain a rerupture. After the treatment with augmented surgery and rehabilitation, there was no significant difference between the patients who sustained a rerupture and patients with no rerupture in all the functional tests except for heel-rise height at 6 months (P = .011), which demonstrated that the mean results were higher for patients who sustained a rerupture (LSI, 87% 6 11%) compared with those who did not sustain a rerupture (LSI, 69% 6 15%). Deep vein thrombosis occurred in 1 patient (2%) in the surgical group and in 2 patients (4%) in the nonsurgical group. The diagnosis was confirmed using the Doppler ultrasound technique. Six patients (12%) in the surgical group were defined as having a superficial wound infection, and they all healed with antibiotics and wound dressings, even though 2 of these patients were treated only on suspicion of a superficial infection. One patient in the surgically treated group had persistent partial sural nerve Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 Vol. 41, No. 12, 2013 Treatment for Acute Achilles Tendon Ruptures 2873 TABLE 3 Functional Test Performance (Limb Symmetry Index) Scores at 6 and 12 Months After Injurya 6-Month Evaluation Test Hopping No. of patients Mean 6 SD Range Hopping (plyometric quotient) No. of patients Mean 6 SD Range Drop CMJ No. of patients Mean 6 SD Range Concentric power No. of patients Mean 6 SD Range Eccentric power No. of patients Mean 6 SD Range Heel-rise repetitions No. of patients Mean 6 SD Range Heel-rise height No. of patients Mean 6 SD Range Heel-rise work No. of patients Mean 6 SD Range Surgical Nonsurgical 42 82 6 36 0-173 42 76 6 33 0-115 42 82 6 35 0-153 42 78 6 32 0-114 45 81 6 21 0-112 45 74 6 12 49-98 47 75 6 34 0-147 46 78 6 58 0-380 47 59 6 21 0-104 46 61 6 33 0-147 47 89 6 27 22-193 46 81 6 24 24-122 47 72 6 15 40-107 46 66 6 15 35-98 47 65 6 23 7-127 46 56 6 22 8-107 12-Month Evaluation P Value b Surgical Nonsurgical 37 103 6 36 0-200 43 86 6 36 0-147 37 101 6 29 0-174 43 88 6 32 0-127 40 91 6 15 70-131 43 82 6 13 59-123 40 95 6 39 40-200 44 84 6 36 34-216 40 83 6 29 51-170 43 81 6 35 0-169 41 93 6 17 52-138 45 90 6 17 26-120 41 80 6 15 46-116 45 79 6 16 28-105 41 76 6 19 21-120 45 71 6 19 7-105 .43 P Valueb .040 .66 .06 .06 .003 .78 .17 .62 .84 .12 .34 .06 .93 .09 .20 a Limb symmetry index values are expressed as a percentage and calculated as the involved limb score/uninvolved limb score 3 100. Drop CMJ, drop countermovement jump. b Boldface indicates significant difference. disturbance. The brace caused minor temporary problems with macerated skin and pain- and pressure-induced nerve disturbances in 13 surgically treated patients (26%) and in 2 (4%) nonsurgically treated patients. DISCUSSION The results of the present study demonstrate that surgical repair with a stable suture technique and accelerated rehabilitation, including immediate weightbearing, range of motion, and strength training, is a well-tolerated method without any major soft tissue–related complications. However, there is no conclusive evidence that this treatment was superior to nonsurgical treatment with immediate weightbearing in a brace when comparing functional results. There were no significant differences in the ATRS between surgical and nonsurgical treatments at the 6- and 12-month evaluations (Table 2). The ATRS is the primary outcome variable in the present study, and we were therefore unable to confirm our hypothesis. The ATRS nevertheless shows a tendency toward a favorable result for surgical treatment at 3 months compared with nonsurgical treatment, even though this was not statistically significant. Nilsson-Helander et al29 reported similar results in a previous study. However, the fact that neither group in this study achieved full recovery in patient-reported outcome scores at the 12-month follow-up is of greater importance, and this is similar to what has been reported in previous studies.29,47 We were unable to find any differences between surgical and nonsurgical treatments in physical activity level, and both groups had returned to their previous activity level by 12 months after injury. Moller et al26 showed in both surgical and nonsurgical groups that 46% of patients did not resume their preinjury level of sports, and Cetti et al7 have also reported similar results in which only Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 2874 Olsson et al The American Journal of Sports Medicine 57% of surgically treated and 29% of nonsurgically treated patients resumed their previous level of sports activity. Nilsson-Helander et al29 reported significantly reduced physical activity levels in both surgical and nonsurgical treatment groups at 12 months. In contrast, this study revealed no significant differences in physical activity level when comparing the preinjury and 12-month data. Whether early weightbearing and exercises or any other aspect of the current rehabilitation protocol might have a positive effect on the return to physical activity needs to be further investigated. In the present study, we used 2 different scores to evaluate measurements of quality of life: the FAOS QOL and EQ-5D. We were unable to find any differences between the treatment groups in terms of quality of life scores as measured by either of these. The 2 scores describe different properties of quality of life, and the more general quality of life score, the EQ-5D, showed significantly lower values at 12 months after injury compared with the preinjury values. The FAOS QOL subscores at 12 months, with a mean of approximately 75 for both groups, also indicate that ankle- and foot-related quality of life is negatively affected. To summarize, this indicates that an Achilles tendon rupture does not simply affect the lower limb but also affects the patient’s general quality of life. All LSI variables in the surgically treated group were numerically higher when assessed by the functional evaluation tests including jump, power, and endurance at the 12month follow-up compared with the nonsurgical group, although statistically significant differences were verified only for hopping and the drop CMJ only (Table 3). Favorable functional results after surgical treatment at 12 months have also been reported in a study by Nilsson-Helander et al.29 In that study, the same functional evaluation was used, and the absolute values in the different tests were 4% to 11% higher in favor of surgical treatment compared with nonsurgical treatment, but with a statistically significant difference only in the heel-rise work test. We report approximately the same results in the 2 studies, indicating a possible advantage for surgical treatment. To verify this, a larger study population is required to determine whether surgical treatment is indeed superior when it comes to regaining function. In the present study, there were no reruptures in the surgically treated group, while there were 5 in the nonsurgically treated group (P = .057). Despite the difference in numbers, this is not statistically significant, but it could have been interpreted as a type II error. Most studies, apart from the one by Moller et al,26 have not shown any statistically significant difference between surgical and nonsurgical treatment in terms of the rerupture rate. Pooled statistical analyses3,14,19,47 have demonstrated a significantly reduced risk of reruptures in surgically treated Achilles tendon ruptures, but these meta-analyses did not conclude that one treatment is superior to the other based on the total number of complications and other evaluations. In many of the tests, function in the injured leg was significantly reduced compared with the uninjured leg at 12 months after injury (Table 3), and other studies have presented similar results. It is important to understand why not all patients regain full function to make it possible to further optimize the treatment. Elongation of the tendon might be one reason for the impaired function of the injured leg. Kangas et al15 concluded that patients with less tendon elongation achieved a better clinical outcome, and 2 studies have shown a separation of tendon ends at 4 months after injury in surgically treated Achilles tendon ruptures.27,35 Silbernagel et al40 have recently described a method for measuring tendon length and found a significant correlation between tendon elongation and deficits in heel-rise height after an Achilles tendon rupture. If this decrease in heelrise height is indicative of increased tendon length, this could be an important reason for the deficits in function in our study. The correct length of the tendon is probably easier to achieve by surgical treatment compared with nonsurgical treatment, and this could explain the difference in function in favor of surgical treatment. However, further studies are needed to determine the relevance of tendon length and conclude whether this could predict the outcome. The 5 patients who sustained a rerupture and were treated with the augmented surgical technique had similar functional results at both 6 and 12 months after the rerupture compared with the patients with no reruptures at 6 and 12 months after injury. There is therefore no reason to believe that these patients have inferior end results. From this perspective, a rerupture might not produce an inferior end result, apart from a prolonged period of treatment and additional surgery. The clinical experience is that this ‘‘loss of time’’ will have varying implications in individual patients mainly because of different demands in sports and work but also because of a mismatch in expectations regarding healing time. The study protocol in the present study, with immediate treatment in a brace to facilitate full weightbearing, might have some disadvantages. Willits et al47 used the same brace, starting after 2 weeks, when the surgical wound had healed and had 4 superficial infections and 1 deep infection in their group of 72 patients treated with open repair. A pooled analysis by Khan et al19 revealed 7 infections in 173 patients treated with open surgical techniques. The rate in the present study is higher, and one reason for this might be a stretching of the surgical wound due to immediate weightbearing and the somewhat tight environment for the surgical wound inside the brace. Metz et al24 also reported a high incidence of skin-related complications because of the tight environment in a continuously worn brace. The different rates of infection might also be caused, to some extent, by different definitions of postoperative infection. Previous clinical studies23,24,43,47 have shown favorable results after protected weightbearing. Human and animal models1,21 have shown better results when the tendon is loaded during the healing process. The American Academy of Orthopaedic Surgeons (AAOS) guidelines8 also recommend early protected postoperative weightbearing. To our knowledge, Costa el al9 and Metz et al24 are the only previous randomized controlled trials with a rehabilitation protocol with immediate full weightbearing. In the present study, both groups had a treatment protocol that promoted immediate weightbearing, but in contrast to the other studies, this study also included controlled range of motion and strength training early in the surgical group. The Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014 Vol. 41, No. 12, 2013 Treatment for Acute Achilles Tendon Ruptures results of this study support a shift toward early loading of the tendon. The study has certain limitations. First, there is the limitation of not having any biomechanical studies of the suture technique, and we instead used information in the literature to construct our technique.37 Second, the surgically treated group had both an accelerated rehabilitation protocol and surgery as different factors compared with the nonsurgical group. It is possible to argue that it is not known which factor makes the difference, but we consider that surgery is necessary for this accelerated rehabilitation protocol, and we therefore regard surgery and accelerated rehabilitation as 2 parts of the same unit. Third, this study is not blinded. When the study began, only 1 experienced physical therapist was available, and this made correct blinding complicated. Inspecting both the scar and tendon and issuing instructions about the shoes would not have been possible for one person. Fourth, the instructions for the patients stated that full weightbearing was allowed and encouraged from the first day, but we have no measurements of how much the patients actually performed weightbearing. We believe that future studies of early mobilization and weightbearing should include measurements of this kind. Finally, it is possible that we need to consider a possible type II error, which is important when analyzing the superiority of either treatment in terms of function, patient-reported outcomes, and reruptures, as discussed above. This leads to the conclusion that larger randomized controlled studies are needed. Clinically, the findings in the present study show that this type of surgical treatment with accelerated rehabilitation produced no reruptures and that immediate weightbearing is well tolerated in spite of minor complications. This can be regarded as a safe form of treatment in patients who prioritize swift rehabilitation and therefore wish to minimize the risk of a second treatment period and accept the possible downside of surgical treatment. Our data do not support any treatment as being superior to the other, but it is our belief that the choice of treatment should be decided on an individual basis, and it is possible to speculate that this protocol of stable repair with accelerated rehabilitation is preferable for selected highly demanding patients because of the tendency toward favorable results in this group. CONCLUSION The results of the present study demonstrate that our stable surgical repair with accelerated tendon loading could be performed in all (n = 49) patients without reruptures and major soft tissue–related complications. However, this treatment was not significantly superior to nonsurgical treatment in terms of functional results, physical activity, or quality of life. 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Am J Sports Med. 2007;35(12):2033-2038. Watson TW, Jurist KA, Yang KH, Shen KL. The strength of Achilles tendon repair: an in vitro study of the biomechanical behavior in human cadaver tendons. Foot Ankle Int. 1995;16(4):191-195. Willits K, Amendola A, Bryant D, 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(17):2767-2775. Yildirim Y, Esemenli T. Initial pull-out strength of tendon sutures: an in vitro study in sheep Achilles tendon. Foot Ankle Int. 2002;23(12): 1126-1130. For reprints and permission queries, please visit SAGE’s Web site at http://www.sagepub.com/journalsPermissions.nav Downloaded from ajs.sagepub.com at UNIV OF DELAWARE LIB on January 23, 2014