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Immediate full-weight-bearing mobilisation for repaired Achilles tendon ruptures: a pilot study
Injury, Int. J. Care Injured 34 (2003) 874–876
Immediate full-weight-bearing mobilisation for repaired Achilles tendon ruptures: a pilot study M.L. Costa∗ , L. Shepstone, C. Darrah, T. Marshall, S.T. Donell UEA Musculo-Skeletal Research Group and Department of Orthopaedics, The Institute of Orthopaedics, The Norfolk and Norwich University Hospital, Colney Lane, Norwich NR4 7UY, UK Accepted 15 July 2002
Abstract Recent experimental and clinical evidence suggests that early loading and mobilisation for Achilles tendon ruptures may improve functional outcomes. This paper presents the results of a pilot study designed to assess the safety of immediate weight-bearing mobilisation. Twenty-eight operatively repaired patients were randomised to either immediate loading in an orthosis or traditional serial plaster casting. An independent observer, blinded to treatment, assessed the results. Improved clinical, anthropometric, and functional outcomes were noted in the immediate loading group. Ultrasound assessment confirmed no deleterious effects upon the tenodesis. There was one re-rupture of the tendon at a minimum follow-up of 1 year. © 2002 Elsevier Science Ltd. All rights reserved.
1. Introduction Rupture of the Achilles tendon is a serious and disabling condition. Current epidemiological data suggests an incidence of 18 per 100 000 per year [1]. This incidence is increasing [2]. The condition typically affects young active adults and is associated with prolonged periods off-work and much longer abstinence from sporting activity [3]. This has significant financial and health implications. Experimental models suggest that early loading of the ruptured Achilles tendon, prevents detrimental alterations in muscle characteristics and favourably influences maturation of collagen fibres within the tendon [4,5]. Early mobilisation and delayed loading have also been advocated by a small number of clinical studies [6–8]. These papers suggest improved functional outcomes. However, none of the studies has used immediate weight-bearing mobilisation and movement. In general, adoption of the principle of early loading and mobilisation has been extremely slow. This may be due to the potential risks of re-rupture or tendon lengthening with early activity. The expense of previous custom-made orthoses may also have contributed. The aim of this pilot study was to test the safety of immediate full-weight-bearing mobilisation following operative repair of the ruptured Achilles tendon. ∗ Corresponding author. E-mail address: [email protected] (M.L. Costa).
Only operatively treated patients were invited to enter the pilot study because of the lower risk of re-rupture in this group [3]. The study is a randomised controlled trial comparing traditional serial plaster casting to immediate loading within an off-the-shelf orthosis. The results of the study will be used to inform a power calculation for a larger, full-scale trial involving both operative and non-operatively treated patients.
2. Methods This study had the approval of The Norwich District Research Ethics and Research Governance Committees. Patients were recruited from the Department of Orthopaedics of the Norfolk and Norwich University Hospital between May 1999 and November 2000. Diagnosis of the ruptured Achilles tendon was made on clinical examination. After discussing the operative and non-operative options [3,9,10], 31 patients elected to undergo operative repair of the tendon. Of these 28 fulfilled the entry criteria and consented to take part in the trial. No patients declined to enter the study having been approached to do so. 2.1. Inclusion criteria • Age over 18 years; • unilateral rupture of the Achilles tendon;
0020-1383/$ – see front matter © 2002 Elsevier Science Ltd. All rights reserved. PII: S 0 0 2 0 - 1 3 8 3 ( 0 2 ) 0 0 2 0 5 - X
M.L. Costa et al. / Injury, Int. J. Care Injured 34 (2003) 874–876
• pre-injury ability to run—indicating functional level; • ability to attend for 1 year follow-up; • informed consent given. 2.2. Exclusion criteria • Previous tendon rupture; • previous tendon surgery; • multiple injuries requiring delayed rehabilitation. Two patients were excluded at operation (one who developed a chest infection and was subsequently treated non-operatively, and one who had a percutaneous repair). Both patients were followed up on an intention-to-treat basis. The remaining 26 patients had a simple open end-to-end operative repair performed under general anaesthetic. The incision and exact repair technique were left to the discretion of the surgeon to ensure generalisability. The limb was placed into a temporary equinus plaster overnight. On the first post-operative day, the plaster group were placed into a below-knee gravity equinus cast and mobilised non-weight-bearing. The early loading group were fitted with an off-the-shelf carbon-fibre orthosis modified to include three 1.5 cm heel raises. They were encouraged to mobilise full-weight-bearing. Patients were clinically reviewed at 2 weekly intervals for 8 weeks. The equinus position of the plaster or the number of the heel raise in the orthosis was reduced at each visit until the patient had attained plantar grade. The orthosis/plaster was then removed. At each visit, the wound was assessed, calf muscle bulk measured and return to normal activities monitored. An ultrasound assessment of the Achilles was made at 6 weeks noting the integrity and dimensions of the tenodesis. This was used as confirmation of the safety of the orthosis. The primary efficacy end-point was return to normal sporting activity. Each patient was then reviewed at 3 months, 6 months and after 1 year. Six patients were lost to follow-up during this period. This left 20 patients with complete data sets at 1 year. At the 6 month review, an independent physiotherapist, blinded to treatment, performed a clinical assessment and measured calf muscle function using the Kincom system [11]. Range of ankle movement, and concentric and eccen-
875
tric peak torques at 30◦ /s were measured and compared to the uninjured limb [12,13]. Each patient was asked to comment on the study design and suggest improvements. Each of the efficacy variables was summarised by the within-group median and semi-interquartile range. A 95% confidence interval (CI) was constructed for the median between-group difference. 3. Results The average age of patients in the study was 41 years. There were 24 male and 4 female patients, where 14 had right and 14 had left Achilles ruptures. All of the patients were recreational/club level sportsmen or women. All of the patients in the immediate loading group of the study were able to fully weight-bear, including climbing stairs, prior to discharge on the second post-operative day. In general, the orthosis was well-tolerated, although several patients complained of chaffing around the ankle. There was one re-rupture in the orthotic group. This happened 3 months post-operatively after a minor fall. This patient had a percutaneous repair and was therefore in breach of the study protocol, but is included here for completeness. Ultrasound assessment of the tenodesis showed no deleterious effects of early loading in any patient. There was a non-significant trend towards increased tendon diameter in the orthotic group on ultrasound measurement. There was one case of transient sural nerve deficit in each group, and one case of delayed wound healing in each group. One patient in the orthotic group had a retained suture removed under local anaesthetic. Table 1 summarises the analysis of the efficacy variables. The immediate weight-bearing group showed a median time to return to normal sporting activity of 6 months. This was 2 months shorter than that of the plaster group. Similarly, the calf muscles of the immediate loading group showed less power loss than the plaster group. The values represent the deficit in calf muscle power of the injured limb expressed as a percentage of the uninjured limb. There was no difference in median peak eccentric torque between the injured and uninjured limbs of the orthosis group. This compared to a median 41% loss of eccentric torque in the injured limb
Table 1 Between-group comparisons of efficacy outcomes Early loading (n = 9)
Plaster (n = 11)
95% CI for median difference
6.0 (2.0) (n = 8)
8.0 (8.0) (n = 9)
(−5.0, 3.5)
Flexion deficit (degrees) Plantar Dorsal
5.0 (3.50) (n = 8) −5.0 (4.25) (n = 8)
5.0 (5.0) (n = 11) 0.0 (5.0) (n = 11)
(−10, 0) (0, 14.0)
Peak torque deficit (%) (at 12 months) Concentric Eccentric
13.5 (50.8) (n = 8) −1.5 (27.8) (n = 8)
29.0 (23.5) (n = 9) 41.0 (26.0) (n = 9)
(−56, 53) (−30, 45)
Time to return to sports (months)
Figures shown are medians (semi-interquartile ranges) with a 95% confidence interval for the median difference between groups.
876
M.L. Costa et al. / Injury, Int. J. Care Injured 34 (2003) 874–876
of the plaster group. For concentric torque, there was a median 13.5% deficit in the injured limb of the orthosis group, compared to 29% deficit in the plaster group. These differences were non-significant in this pilot study. There were no differences in calf muscle bulk as measured clinically. Including the results of the two patients who breached the study protocol, on an intention-to-treat basis, did not alter the outcomes. There was a 5% increase in dorsiflexion in the immediate loading group when comparing the injured and uninjured legs. This was not apparent in the plaster group. Such an increase may reflect a small degree of lengthening of the tendon when subjected to immediate loading, but again this was not statistically significant.
4. Discussion This study suggests that immediate weight-bearing mobilisation of operatively repaired Achilles tendon ruptures is safe and well-tolerated by patients. The data presented in this paper support the hypothesis that such loading and mobilisation may have functional benefits. None of the outcome measurements reached statistical significance, but this is to be expected in a pilot study. The use of a cheap, re-usable, off-the-shelf orthosis, did not affect patient compliance. Several modifications to the study design have been established as a result of this pilot project. The most frequent comment made by patients in the immediate loading group, was regarding the orthosis itself. The ankle part of the carbon-fibre frame caused chaffing when all three heel raises were used. The manufacturers have now made a minor alteration to the frame to alleviate this problem. The study protocol has been altered to include baseline and serial EuroQol [14] and FIL [10,15] questionnaires to assess general and lower limb specific health status respectively. This will facilitate subjective scoring throughout the study. A formal patient satisfaction score has also been incorporated. None of the patients assessed had significant new problems after the first 6 months of the study. On this basis, the blinded assessment of the patients has been standardised at 6 months. Finally, the pilot results have been used in a power analysis to determine the sample size required by a full-randomised controlled trial. The authors would advocate the use of such pilot studies to improve the design of larger clinical trials.
5. Conclusion This trial suggests that immediate controlled weightbearing mobilisation after Achilles repair is safe and may produce functional benefits for the patient. The authors have used this encouraging data as the basis for a multi-centre randomised controlled trial. References [1] Leppilahti J, Orava S. Total Achilles tendon rupture: a review. Sports Med 1998;25(2):79–100. [2] Maffuli M. Current concepts review: rupture of the Achilles tendon. J Bone Jt Surg 1999;81-A(7):1019–36. [3] Cetti R, Christensen S, Ejsted R, Jensen NM, Jorgensen U. Operative versus non-operative treatment of Achilles tendon rupture. Am J Sports Med 1993;21(6):791–9. [4] Rantanen J, Hurme T, Kalimo H. Calf muscle atrophy and Achilles tendon healing following experimental tendon division and repair. Scand J Sci Sports 1999;9:57–61. [5] Qin L, Appell HJ, Chan KM, Maffulli N. Electrical stimulation prevents immobilisation atrophy in skeletal muscle in rabbits. Arch Phys Med Rehab 1997;78:512–7. [6] Saw Y, Baltzopoulos V, Lim A, Rostron PKM, Bolton-Maggs BG, Calver RF. Early mobilisation after operative repair of ruptured Achilles tendon. Injury 1993;24(7):479–84. [7] Roberts CP, Palmer S, Vince A, Deliss LJ. Dynamised cast management of Achilles tendon ruptures. Injury 2001;32:423–6. [8] Saleh M, Marshall PD, Senior R, MacFarlane A. The Sheffield splint for controlled early mobilisation after rupture of the calcaneal tendon. A prospective, randomised comparison with plaster treatment. J Bone Jt Surg 1992;74-B:206–9. [9] Nistor L. Surgical and non-surgical treatment of Achilles tendon rupture. J Bone Jt Surg 1981;63-A:394–9. [10] Moller M, Movin T, Granhed H, Lind K, Faxen E, Karlsson J. Acute rupture of tendon Achilles. J Bone Jt Surg 2001;83-B(6): 843–8. [11] Farrell M, Richards JG. Analysis of the reliability and validity of the kinetic communicator exercise device. Med Sci Sports Exerc 1986;18(1):44–9. [12] Leppilahti J, Siira P, Vanharanta H, Orava S. Isokinetic evaluation of calf muscle performance after Achilles rupture repair. Int J Sports Med 1996;17:619–23. [13] Chester R, Costa ML, Shepstone L, Donell ST. The reliability of computer dynamometry in assessing recovery from Achilles tendon rupture, unpublished data. [14] Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53–72. [15] Salen BA, Sprangfort EV, Nygren AK, Nordemar R. The disability rating index: an instrument for the assessment of disability in clinical settings. J Clin Epidemiol 1994;47(12):1423–34.
Immediate full-weight-bearing mobilisation for repaired Achilles tendon ruptures: a pilot study M.L. Costa∗ , L. Shepstone, C. Darrah, T. Marshall, S.T. Donell UEA Musculo-Skeletal Research Group and Department of Orthopaedics, The Institute of Orthopaedics, The Norfolk and Norwich University Hospital, Colney Lane, Norwich NR4 7UY, UK Accepted 15 July 2002
Abstract Recent experimental and clinical evidence suggests that early loading and mobilisation for Achilles tendon ruptures may improve functional outcomes. This paper presents the results of a pilot study designed to assess the safety of immediate weight-bearing mobilisation. Twenty-eight operatively repaired patients were randomised to either immediate loading in an orthosis or traditional serial plaster casting. An independent observer, blinded to treatment, assessed the results. Improved clinical, anthropometric, and functional outcomes were noted in the immediate loading group. Ultrasound assessment confirmed no deleterious effects upon the tenodesis. There was one re-rupture of the tendon at a minimum follow-up of 1 year. © 2002 Elsevier Science Ltd. All rights reserved.
1. Introduction Rupture of the Achilles tendon is a serious and disabling condition. Current epidemiological data suggests an incidence of 18 per 100 000 per year [1]. This incidence is increasing [2]. The condition typically affects young active adults and is associated with prolonged periods off-work and much longer abstinence from sporting activity [3]. This has significant financial and health implications. Experimental models suggest that early loading of the ruptured Achilles tendon, prevents detrimental alterations in muscle characteristics and favourably influences maturation of collagen fibres within the tendon [4,5]. Early mobilisation and delayed loading have also been advocated by a small number of clinical studies [6–8]. These papers suggest improved functional outcomes. However, none of the studies has used immediate weight-bearing mobilisation and movement. In general, adoption of the principle of early loading and mobilisation has been extremely slow. This may be due to the potential risks of re-rupture or tendon lengthening with early activity. The expense of previous custom-made orthoses may also have contributed. The aim of this pilot study was to test the safety of immediate full-weight-bearing mobilisation following operative repair of the ruptured Achilles tendon. ∗ Corresponding author. E-mail address: [email protected] (M.L. Costa).
Only operatively treated patients were invited to enter the pilot study because of the lower risk of re-rupture in this group [3]. The study is a randomised controlled trial comparing traditional serial plaster casting to immediate loading within an off-the-shelf orthosis. The results of the study will be used to inform a power calculation for a larger, full-scale trial involving both operative and non-operatively treated patients.
2. Methods This study had the approval of The Norwich District Research Ethics and Research Governance Committees. Patients were recruited from the Department of Orthopaedics of the Norfolk and Norwich University Hospital between May 1999 and November 2000. Diagnosis of the ruptured Achilles tendon was made on clinical examination. After discussing the operative and non-operative options [3,9,10], 31 patients elected to undergo operative repair of the tendon. Of these 28 fulfilled the entry criteria and consented to take part in the trial. No patients declined to enter the study having been approached to do so. 2.1. Inclusion criteria • Age over 18 years; • unilateral rupture of the Achilles tendon;
0020-1383/$ – see front matter © 2002 Elsevier Science Ltd. All rights reserved. PII: S 0 0 2 0 - 1 3 8 3 ( 0 2 ) 0 0 2 0 5 - X
M.L. Costa et al. / Injury, Int. J. Care Injured 34 (2003) 874–876
• pre-injury ability to run—indicating functional level; • ability to attend for 1 year follow-up; • informed consent given. 2.2. Exclusion criteria • Previous tendon rupture; • previous tendon surgery; • multiple injuries requiring delayed rehabilitation. Two patients were excluded at operation (one who developed a chest infection and was subsequently treated non-operatively, and one who had a percutaneous repair). Both patients were followed up on an intention-to-treat basis. The remaining 26 patients had a simple open end-to-end operative repair performed under general anaesthetic. The incision and exact repair technique were left to the discretion of the surgeon to ensure generalisability. The limb was placed into a temporary equinus plaster overnight. On the first post-operative day, the plaster group were placed into a below-knee gravity equinus cast and mobilised non-weight-bearing. The early loading group were fitted with an off-the-shelf carbon-fibre orthosis modified to include three 1.5 cm heel raises. They were encouraged to mobilise full-weight-bearing. Patients were clinically reviewed at 2 weekly intervals for 8 weeks. The equinus position of the plaster or the number of the heel raise in the orthosis was reduced at each visit until the patient had attained plantar grade. The orthosis/plaster was then removed. At each visit, the wound was assessed, calf muscle bulk measured and return to normal activities monitored. An ultrasound assessment of the Achilles was made at 6 weeks noting the integrity and dimensions of the tenodesis. This was used as confirmation of the safety of the orthosis. The primary efficacy end-point was return to normal sporting activity. Each patient was then reviewed at 3 months, 6 months and after 1 year. Six patients were lost to follow-up during this period. This left 20 patients with complete data sets at 1 year. At the 6 month review, an independent physiotherapist, blinded to treatment, performed a clinical assessment and measured calf muscle function using the Kincom system [11]. Range of ankle movement, and concentric and eccen-
875
tric peak torques at 30◦ /s were measured and compared to the uninjured limb [12,13]. Each patient was asked to comment on the study design and suggest improvements. Each of the efficacy variables was summarised by the within-group median and semi-interquartile range. A 95% confidence interval (CI) was constructed for the median between-group difference. 3. Results The average age of patients in the study was 41 years. There were 24 male and 4 female patients, where 14 had right and 14 had left Achilles ruptures. All of the patients were recreational/club level sportsmen or women. All of the patients in the immediate loading group of the study were able to fully weight-bear, including climbing stairs, prior to discharge on the second post-operative day. In general, the orthosis was well-tolerated, although several patients complained of chaffing around the ankle. There was one re-rupture in the orthotic group. This happened 3 months post-operatively after a minor fall. This patient had a percutaneous repair and was therefore in breach of the study protocol, but is included here for completeness. Ultrasound assessment of the tenodesis showed no deleterious effects of early loading in any patient. There was a non-significant trend towards increased tendon diameter in the orthotic group on ultrasound measurement. There was one case of transient sural nerve deficit in each group, and one case of delayed wound healing in each group. One patient in the orthotic group had a retained suture removed under local anaesthetic. Table 1 summarises the analysis of the efficacy variables. The immediate weight-bearing group showed a median time to return to normal sporting activity of 6 months. This was 2 months shorter than that of the plaster group. Similarly, the calf muscles of the immediate loading group showed less power loss than the plaster group. The values represent the deficit in calf muscle power of the injured limb expressed as a percentage of the uninjured limb. There was no difference in median peak eccentric torque between the injured and uninjured limbs of the orthosis group. This compared to a median 41% loss of eccentric torque in the injured limb
Table 1 Between-group comparisons of efficacy outcomes Early loading (n = 9)
Plaster (n = 11)
95% CI for median difference
6.0 (2.0) (n = 8)
8.0 (8.0) (n = 9)
(−5.0, 3.5)
Flexion deficit (degrees) Plantar Dorsal
5.0 (3.50) (n = 8) −5.0 (4.25) (n = 8)
5.0 (5.0) (n = 11) 0.0 (5.0) (n = 11)
(−10, 0) (0, 14.0)
Peak torque deficit (%) (at 12 months) Concentric Eccentric
13.5 (50.8) (n = 8) −1.5 (27.8) (n = 8)
29.0 (23.5) (n = 9) 41.0 (26.0) (n = 9)
(−56, 53) (−30, 45)
Time to return to sports (months)
Figures shown are medians (semi-interquartile ranges) with a 95% confidence interval for the median difference between groups.
876
M.L. Costa et al. / Injury, Int. J. Care Injured 34 (2003) 874–876
of the plaster group. For concentric torque, there was a median 13.5% deficit in the injured limb of the orthosis group, compared to 29% deficit in the plaster group. These differences were non-significant in this pilot study. There were no differences in calf muscle bulk as measured clinically. Including the results of the two patients who breached the study protocol, on an intention-to-treat basis, did not alter the outcomes. There was a 5% increase in dorsiflexion in the immediate loading group when comparing the injured and uninjured legs. This was not apparent in the plaster group. Such an increase may reflect a small degree of lengthening of the tendon when subjected to immediate loading, but again this was not statistically significant.
4. Discussion This study suggests that immediate weight-bearing mobilisation of operatively repaired Achilles tendon ruptures is safe and well-tolerated by patients. The data presented in this paper support the hypothesis that such loading and mobilisation may have functional benefits. None of the outcome measurements reached statistical significance, but this is to be expected in a pilot study. The use of a cheap, re-usable, off-the-shelf orthosis, did not affect patient compliance. Several modifications to the study design have been established as a result of this pilot project. The most frequent comment made by patients in the immediate loading group, was regarding the orthosis itself. The ankle part of the carbon-fibre frame caused chaffing when all three heel raises were used. The manufacturers have now made a minor alteration to the frame to alleviate this problem. The study protocol has been altered to include baseline and serial EuroQol [14] and FIL [10,15] questionnaires to assess general and lower limb specific health status respectively. This will facilitate subjective scoring throughout the study. A formal patient satisfaction score has also been incorporated. None of the patients assessed had significant new problems after the first 6 months of the study. On this basis, the blinded assessment of the patients has been standardised at 6 months. Finally, the pilot results have been used in a power analysis to determine the sample size required by a full-randomised controlled trial. The authors would advocate the use of such pilot studies to improve the design of larger clinical trials.
5. Conclusion This trial suggests that immediate controlled weightbearing mobilisation after Achilles repair is safe and may produce functional benefits for the patient. The authors have used this encouraging data as the basis for a multi-centre randomised controlled trial. References [1] Leppilahti J, Orava S. Total Achilles tendon rupture: a review. Sports Med 1998;25(2):79–100. [2] Maffuli M. Current concepts review: rupture of the Achilles tendon. J Bone Jt Surg 1999;81-A(7):1019–36. [3] Cetti R, Christensen S, Ejsted R, Jensen NM, Jorgensen U. Operative versus non-operative treatment of Achilles tendon rupture. Am J Sports Med 1993;21(6):791–9. [4] Rantanen J, Hurme T, Kalimo H. Calf muscle atrophy and Achilles tendon healing following experimental tendon division and repair. Scand J Sci Sports 1999;9:57–61. [5] Qin L, Appell HJ, Chan KM, Maffulli N. Electrical stimulation prevents immobilisation atrophy in skeletal muscle in rabbits. Arch Phys Med Rehab 1997;78:512–7. [6] Saw Y, Baltzopoulos V, Lim A, Rostron PKM, Bolton-Maggs BG, Calver RF. Early mobilisation after operative repair of ruptured Achilles tendon. Injury 1993;24(7):479–84. [7] Roberts CP, Palmer S, Vince A, Deliss LJ. Dynamised cast management of Achilles tendon ruptures. Injury 2001;32:423–6. [8] Saleh M, Marshall PD, Senior R, MacFarlane A. The Sheffield splint for controlled early mobilisation after rupture of the calcaneal tendon. A prospective, randomised comparison with plaster treatment. J Bone Jt Surg 1992;74-B:206–9. [9] Nistor L. Surgical and non-surgical treatment of Achilles tendon rupture. J Bone Jt Surg 1981;63-A:394–9. [10] Moller M, Movin T, Granhed H, Lind K, Faxen E, Karlsson J. Acute rupture of tendon Achilles. J Bone Jt Surg 2001;83-B(6): 843–8. [11] Farrell M, Richards JG. Analysis of the reliability and validity of the kinetic communicator exercise device. Med Sci Sports Exerc 1986;18(1):44–9. [12] Leppilahti J, Siira P, Vanharanta H, Orava S. Isokinetic evaluation of calf muscle performance after Achilles rupture repair. Int J Sports Med 1996;17:619–23. [13] Chester R, Costa ML, Shepstone L, Donell ST. The reliability of computer dynamometry in assessing recovery from Achilles tendon rupture, unpublished data. [14] Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53–72. [15] Salen BA, Sprangfort EV, Nygren AK, Nordemar R. The disability rating index: an instrument for the assessment of disability in clinical settings. J Clin Epidemiol 1994;47(12):1423–34.