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Acute Achilles tendon rupture: minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial

Acute Achilles tendon rupture: minimally invasive surgery versus non operative treatment, with... Background: We present the design of an open randomized multi-centre study on surgical versus conservative treatment of acute Achilles tendon ruptures. The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture. Methods/Design: At least 72 patients with acute Achilles tendon rupture will be randomized to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system. Both treatment arms use a 7 weeks post-rupture rehabilitation protocol. Four hospitals in the Netherlands will participate. Primary end-point will be reduction in complications other than re- rupture. Secondary end-point will be re-rupturing, time off work, sporting activity post rupture, functional outcome by Leppilahti score and patient satisfaction. Patient follow-up will be 12 month. Discussion: By making this design study we wish to contribute to more profound research on AT rupture treatment and prevent publication bias for this open-labelled randomized trial. Trial registration: ISRCTN50141196 Traditionally open surgical repair of a ruptured Achilles Background Controversy continues with regard to the optimal treat- tendon has been the first choice of treatment due to low ment for acute subcutaneous Achilles tendon (AT) rup- re-rupture rates and the possibility for functional post- tures. Treatment can be classified into operative (open or operative splintage [1-4]. But, 34% of patients treated minimally invasive/percutaneous) and non-operative. with open repair suffer from complications other than re- Post operative splintage can be divided into cast immobi- rupture, especially wound infection and adhesions [1-5]. lisation and functional bracing. In general, the outcome after treatment of a re-rupture is poor, but results following treatment of a deep infection Page 1 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 are devastating [6]. Therefore an effort should be made to Methods/Design prevent infectious complications. Many articles on differ- Design of study Context ent types of minimally invasive repair techniques (using limited incisions or performed percutaneously) of rup- The efficacy of minimally-invasive surgery versus func- tured AT's have been published [7-14]. But to date, only tional conservative treatment of acute subcutaneous two 2 randomized trials have been reported [4,15]. In Achilles tendon ruptures will be studied in a randomized Khan's review on randomized trials complications other trial. Four hospitals in the Netherlands will participate in than re-rupture were substantially reduced with percuta- the study, one of them being a university medical centre. neous repair techniques but data were very limited. Data The Medical Research Ethics Committee of all the partici- on complications using limited incision techniques are pating hospitals approved the study protocol. even more scant. As minimally invasive techniques differ it is hard to compare other techniques with these num- Patient selection and informed consent bers. An advantage of most minimally invasive techniques All patients who report to the emergency department of is smaller scars and less damage to the delicate blood sup- one of the participating hospitals with an acute Achilles ply of the AT. Importantly, in most patients minimally tendon rupture will be considered for entering the study invasive surgery does allow functional rehabilitation [7]. protocol. Inclusion and exclusion criteria are listed in Patients treated by functional rehabilitation after opera- table 1 and will be checked by an emergency room doctor, tion rather than cast immobilisation are reported to have surgical resident or surgeon. All eligible patients are asked a shorter in-patient stay, less time off work and a quicker to provide written informed consent. return to sporting activities. In addition, lower complica- tion rates, including re-ruptures, are reported [1-5]. Randomisation and concealment Randomisation is concealed by a specially designed inter- The main advantage of conservative, i.e. non-operative net site. Randomisation is in blocks (4 blocks) and strati- treatment is elimination of wound complications and fied by centre. The treatment nature is open labelled for intra-operative sural nerve damage. Complications other patients, physicians and physiotherapists. During follow- than re-rupture are reported to reduce to 3% [5]. But, con- up visits physical examination reveals the allocated treat- servative treatment with cast immobilisation has shown ment to patient and assessor. to increase the re-rupture rate [1,5] and cast immobilisa- tion induces delayed recovery due to calf muscle weakness Interventions as a result of long immobilisation of the ankle joint. In Surgical therapy consists of a minimally invasive tech- contrast, conservative treatment by functional bracing nique (Figure 1) [7]. The same protocol for the operative does allow immediate weight bearing, preventing calf procedure was used by all surgeons and residents in the muscle weakness and enabling fast recovery. In three stud- participating hospitals. Also, before study participation all ies conservative treatment of AT rupture with functional surgeons were familiar with the operative procedure. A bracing did not result in increased re-rupture rates [16- less than 5 cm longitudinal incision is made over the pos- 18]. But since only one of these is a randomized trial [17], terior aspect of the affected leg just proximal to the rupture more high quality data from randomized prospective site. The incision is slightly medially placed. The subcuta- studies is needed. We hypothesized that compared to sur- neous fat is divided and the peritendineum opened. Then gical treatment, conservative treatment with functional a Bunell type suture is placed though the proximal end of bracing will reduce the absolute risk of complications the Achilles tendon (PDS 1.0). With a hollow mandarin other than re-rupture with 30%. the suture is tunnelled to the lateral aspect of the calcaneal bone and guided out through a 5 mm stab incision. A hole is drilled through the calcaneal bone 1 cm distal to the tendon insertion (exit through 5 mm stab incision medi- Table 1: Inclusion and exclusion criteria Inclusion Criteria Exclusion criteria Achilles tendon rupture. Re-rupture/bilateral rupture/open rupture. Treatment starts within 72 hours. Combination with fracture of foot or ankle. Diagnoses by physical examination: palpable gap and calf muscle squeeze Former application (injection) of local corticosteroids in tendon area. test. Age 18–65 years. Contra-indications for surgery. Written informed consent. Physical or mental handicaps that do not allow functional treatment or otherwise interfere with the ability to follow-up on the study protocol. Page 2 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 Vacoped Figure 2 Vacoped. Vacoped bracing system (Company OPED, Valley, Ger- many) is a multifunctional splint consisting of several components. The essential parts are the dorsal and ventral shell, the vacuum cushion with changeable terry cloth covers, the belts with security locks and the removable sole. Prior to study use the brace was successfully used in Surgical repair technique Figure 1 a small pilot series and an instructions meeting on brace Surgical repair technique. Taken from [7]. application was held in all participating hospitals. In the first two weeks the brace is fixed in 30° plantar flexion. ally). The PDS in guided though the hole. Now the man- The following 2 weeks in is in rigid 15° plantar flexion. darin is used to guide the suture back to the proximal site The last two weeks the brace is dynamic from neutral posi- of the tendon. After the foot is placed in plantar flexion tion to 30° plantar flexion. Full weight bearing is allowed the suture is tied. After wound closure a cast is applied during the 6 weeks of bracing, not allowing sporting activ- with the foot still in plantar flexion. After one week a tape ities or walking stairs on tiptoes. Crutches are advised in bandage is applied for a total period of 6 weeks. In the first the first week of casting, thereafter for maintenance of bal- two weeks the tape bandage is supported by a 2 cm heel ance, but only if necessary. raise. The following 2 weeks the heel raise is reduced to 1 cm. The last two weeks the heel raise is removed (tape After tape or brace removal patients were advised further bandage will be renewed every time the heel raise is rehabilitation with physiotherapist and were allowed changed). Full weight bearing is allowed during the 6 sports 3 months after rupture. Patients were free to choose weeks of tape bandage, not allowing sporting activities or their physiotherapist. walking stairs on tiptoes. Crutches are advised in the first week of casting, thereafter for maintenance of balance, but Design of collection of data Primary endpoint only if necessary. complications other than re-rupture, i.e. infection, dis- Conservative therapy consists of a cast in plantar flexion turbed wound healing, sural nerve injury, scar adhesions, for one week. After one week a functional bracing system deep vein thrombosis and all other complications per (Vacoped, Figure 2) [19] is applied for 6 weeks. The treatment group. Page 3 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 During follow-up all complications will be documented moments of follow-up. Differences between groups for by a surgeon or resident according to a standardised pro- the number of complications and distribution of other cedure using the definitions of complications presented in endpoints will be calculated for each outcome measure the Table 2. All complications will be included in the final with a 95% confidence interval. The study groups will be analysis of results. compared with the chi-square test for categorical outcome variables and the independent sample Student t test for Secondary endpoint continuous outcome variables. The dropouts and with- re-rupturing (clinical diagnosis supported by ultrasound), drawals will be summarized and analyzed by treatment time off work, sporting activity post rupture and patient groups. A listing of subject with withdrawal with the date satisfaction. The Thompson test is used for clinical diag- and reasons for termination will be provided. nosis of re-rupture. Failure in plantar movement of the foot during calf muscle squeeze is considered a positive Because we standardised the intevention procedures we sign for re-rupture. Ultrasound evaluation for re-rupture is do not anticipate important differences between centers. performed in neutral ankle position. Complete tendon So we do not stratify our primary analysis for center. How- rupture with tendon gap was considered a re-rupture. ever, when eventually differences may occur we will Time off work will be registered by a patient diary. Com- explore their effect in a secondary analysis (Mantel-Haen- plete return to profession was used as endpoint. Stratifica- szel). All analysis in SPSS (SPSS Inc, Chicago Illinois). tion to type of profession (sedentary and non-sedentary) Sample size will be performed afterwards. A visual analogue scale (VAS) on patient satisfaction with treatment will be meas- Sample size is calculated on the basis of complication ured at 7 weeks, 3 and 12 month. Patient outcome will other than re-rupture. With conservative treatment using also be evaluated by the Leppilahti scoring method, a clin- this new type of functional bracing we hypothesized a ical scoring system, including subjective assessment of 30% reduction in the absolute risk for complications symptoms and evaluation of ankle range of motion and other than re-rupture. This risk reduction is similar to the isokinetic measurement of ankle plantar flexion and dor- risk reduction obtained in the systematic review on open sifexion strengths (Table 3) [20]. versus conservative treatment by Khan: risk of complica- tions for open repair being 34% [5]. Prospective data on Follow-up the risk of complications of minimally invasive repair is Follow-up visits for assessment of primary and secondary very scant. The Khan review provides the best empirical endpoints will be scheduled every week during the first 7 estimate for the complication risk associated with surgical weeks. Thereafter, follow-up visits will be planned at 3, 6 repair. Therefore we decided to use this risk estimate of and 12 month. Any other consultation for complaints complications of open repair for the sample size calcula- concerning the Achilles tendon area will be documented. tion. With a one-sided α of 0.05, a statistical power of (1- β) of 0.80, and an attrition rate of 10% we need to rand- Design of analysis omize at least 36 patients per treatment arm. Results will be analysed according the intention tot treat principle. Discussion This study is primarily designed to evaluate the effective- Data analysis ness of conservative treatment of acute AT ruptures, using The study groups will be compared for their baseline char- a functional bracing system, in reducing complications acteristics. The number of complications will be calcu- other than re-rupture. A comparison is made between this lated for the primary endpoint. Distribution measures will functional bracing system and a minimally invasive oper- be calculated for the secondary endpoints at the different ative repair of acute AT ruptures. Both treatment options Table 2: Definitions of complications used during follow-up. Complication Definition Infection Clinical signs of wound infection, i.e. redness, swelling, pain and functional impairment. Deep infection is defined as an infection beyond skin or subcutaneous fat needing surgical treatment in the operating theatre. Disturbed wound healing Keloid formation or hypertrophic scar, secondary wound healing, protruding PDS knot. Sural nerve injury Any sign of altered sensibility in the sural nerve area diagnosed by surgeon or surgical resident (using touch and pin prick test). Scar adhesion Clinical signs of adhesion of skin to underlying tissue layers. Clear wound retraction at ankle movement. Deep vein thrombosis Clinical and ultrasonographic signs of deep vein thrombosis of the ipsilateral lower leg. Other complications Any complication met during follow-up. Page 4 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 Table 3: Leppilahti score. Clinical factors Scores (points)* Pain None 15 Mild, no limitations on recreational activities 10 Moderate, limitations on recreational, but not daily activities 5 Severe, limitations on recreational and daily activities 0 Stiffness None 15 Mild, occasional, no limitations on recreational activities 10 Moderate, limitations on recreational, but not daily activities 5 Severe, limitations on recreational and daily activities 0 Calf muscle weakness (subjective) None 15 Mild, no limitations on recreational activities 10 Moderate, limitations on recreational, but not daily activities 5 Severe, limitations on recreational and daily activities 0 Footwear restrictions None 10 Mild, most shoes tolerated 5 Moderate, unable to tolerate fashionable shoes, modified shoes tolerated 0 Active range of motion (ROM) difference between ankles Normal (<6°) 15 Mild (6°–10°) 10 Moderate (11°–15°) 5 Severe (>15°) 0 Subjective result Very satisfied 15 Satisfied with minor reservations 10 Satisfied with major reservations 5 dissatisfied 0 Isokinetic muscle strength (score) Excellent 15 Good 10 Fair 5 poor 0 * Maximum overall score 100. An overall score of 90–100 rates excellent, 75–85 is good, 60–70 is fair and <55 is poor. used in this comparison allow immediate full weight lem of publication bias, i.e. selective publication of posi- bearing so none of the patients is denied the purported tive associations and disregarding negative and weak advantage of a functional after treatment [2,5,21-24]. associations, prevent unnecessary duplication of research efforts and duplicate publication [25]. To our knowledge, There have been randomized clinical trials on treatment there has never been a design study published regarding of acute Achilles tendon rupture but the methodological treatment of AT ruptures. By making this design study we rigour is often low. There is a need for more rigorous wish to contribute to more profound research on AT rup- designed studies on AT rupture treatment as this subject is ture treatment and prevent publication bias for this open- still very much under debate. By publishing our protocol labelled randomized trial. we wish to show our care for a profound design and meth- odological quality of our protocol. Moreover, when the Competing interests design of a study is published it will help to achieve trans- The author(s) declare that they have no competing inter- parency about why and how studies are undertaken. The ests. publication of a study design may help to reduce the prob- Page 5 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 19. Meyer T, Meyer J, Scola E: Achilles tendon rupture. Operative Authors' contributions tendon suture and semifunctional aftercare with vacuum RM main author of study design. brace system (Vacoped). Chir praxis 1998, 54:101-8. 20. Leppilahti J, Forsman K, Puranen J, Orava S: Outcome and prog- nostic factors of Achilles rupture repair using a new scoring GK first initiated the trial and participated in designing the method. Clin Orthop 1998, 346:152-161. treatment protocol for operative and non-operative treat- 21. Kangas J, Pajala A, Siira P, Hamalainen M, Leppilahti J: Early func- tional treatment versus early immobilization in tension of ment. the musculotendinous unit after Achilles rupture repair: A prospective, randomized, clinical study. J of Trauma: Injury, Inf EV first initiated the trial. Especially involved in all clinical and Crit Care 2003, 54:1171-81. 22. Kerkhoffs GM, Struijs PA, Raaymakers EL, Marti RK: Functional aspects of the trial and study design. treatment after surgical repair of acute Achilles tendon rup- ture: wrap vs walking cast. Arch Orthop Trauma Surg 2002, GH contributed to methodology of the study design. 122:102-5. 23. Maffulli N, Tallon C, Wong J, Lim KP, Bleakney R: Early weightbear- ing and ankle mobilization after open repair of acute mid- All authors read and approved the final manuscript. substance tears of the achilles tendon. Am J Sports Med 2003, 31(5):692-700. 24. Mortensen NH, Skov O, Jensen PE: Early motion of the ankle References after operative treatment of a rupture of the Achilles ten- 1. Moller M, Movin T, Granhed H, Lind K, Faxen E, Karlsson J: Acute don. A prospective, randomized clinical and radiographic rupture of tendon Achilles. A prospective randomized study study. J Bone Joint Surg (Am) 1999, 81:983-90. of comparison between surgical and non-surgical treatment. 25. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, J Bone Joint Surg (Br) 2001, 83:843-8. Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, 2. Cetti R, Hendriksen LO, Jacobsen KS: A new treatment of rup- Van Der Weyden MB, International Committee of medical Journal tured Achilles tendons. A prospective randomized study. Editors: Clinical trial registration: a statement from the Inter- Clin Orthop 1994, 308:155-65. national Committee of medical Journal Editors. Lancet 2004, 3. Nistor L: Surgical and non-surgical treatment of Achilles ten- 364:911-2. don rupture. A prospective randomized study. J Bone Joint Surg (Am) 1981, 63:394-9. Pre-publication history 4. Schroeder D, Lehmann M, Steinbrueck K: Treatment of acute Achilles tendon ruptures: open vs. percutaneous repair vs The pre-publication history for this paper can be accessed conservative treatment. A prospective randomized study. here: Orthopeadic Transactions 1997, 21:1228. 5. Khan RJ, Fick D, Brammar TJ, Crawford J, Parker MJ: Interventions for treating acute Achilles tendon ruptures. Cochrane Database http://www.biomedcentral.com/1471-2474/8/108/pre Syst Rev 2004, 3:CD003674. pub 6. Pajala A, Kangas J, Ohtonen P, Leppilahti J: Rerupture and deep infection following treatment of total Achilles tendon rup- ture. J Bone Joint Surg Am 2002, 84—A(11):2016-2021. 7. Bijlsma TS, van der Werken C: Operative treatment of Achilles tendon rupture: a minimally invasive technique allowing functional after-treatment. Orthop Traumatol 2000, 8:285-290. 8. Assal M, Jung M, Stern R, Rippstein P, Delmi M, Hoffmeyer P: Lim- ited open repair of Achilles tendon rupture: a technique with new instruments and findings of a prospective multicenter study. J Bone Joint Surg (Am) 2002, 84:161-70. 9. Rebeccato A, Santini S, Salmaso G, Nogarin L: Repair of the Achil- les tendon rupture: a functional comparison of three surgical techniques. J Foot Ankle Surg 2001, 40:188-94. 10. Kakiuchi M: A combined open and percutaneous technique for repair of tendo Achilles. J Bone Joint Surg (Br) 1995, 77:60-3. 11. Bradley JP, Tibone JE: Percutaneous and open surgical repairs of Achilles tendon ruptures. A comparative study. Am J Sports Med 1990, 18:188-195. 12. Rowley DI, Scotland TR: Rupture of the Achilles tendon treated by a simple operative procedure. Injury 1982, 14:252-254. 13. Ma GW, Griffith TG: Percutaneous repair of acute closed rup- tured Achilles tendon: a new technique. Clin Orthop 1977, 128:247-255. Publish with Bio Med Central and every 14. Webb JM, Bannister GC: Percutaneous repair of the ruptured scientist can read your work free of charge tendo Achilles. J Bone Joint Surg 1999, 81:877-80. 15. Lim J, Dalal R, Waseem M: Percutaneous vs. open repair of the "BioMed Central will be the most significant development for ruptured Achilles tendon. A prospective randomized con- disseminating the results of biomedical researc h in our lifetime." trolled study. Foot & Ankle Int 2001, 22:559-68. Sir Paul Nurse, Cancer Research UK 16. Roberts CP, Palmer S, Vince A, Deliss LJ: Dynamised cast manage- ment of Achilles tendon ruptures. Injury 2001, 32(5):423-426. Your research papers will be: 17. Saleh M, Marshall PD, Senior R, MacFarlane A: The Sheffield splint for controlled early mobilisation after rupture of the calca- available free of charge to the entire biomedical community neal tendon. A prospective, randomised comparison with peer reviewed and published immediately upon acceptance plaster treatment. J Bone Joint Surg Br 1992, 74(2):206-209. 18. McComis GP, Nawoczenski DA, DeHaven KE: Functional bracing cited in PubMed and archived on PubMed Central for rupture of the Achilles tendon. J Bone Joint Surg Am 1997, yours — you keep the copyright 79(12):1799-1808. BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 6 of 6 (page number not for citation purposes) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Musculoskeletal Disorders Springer Journals

Acute Achilles tendon rupture: minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial

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Springer Journals
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Copyright © 2007 by Metz et al; licensee BioMed Central Ltd.
Subject
Medicine & Public Health; Orthopedics; Rehabilitation; Rheumatology; Sports Medicine; Internal Medicine; Epidemiology
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1471-2474
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10.1186/1471-2474-8-108
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17986319
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Abstract

Background: We present the design of an open randomized multi-centre study on surgical versus conservative treatment of acute Achilles tendon ruptures. The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture. Methods/Design: At least 72 patients with acute Achilles tendon rupture will be randomized to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system. Both treatment arms use a 7 weeks post-rupture rehabilitation protocol. Four hospitals in the Netherlands will participate. Primary end-point will be reduction in complications other than re- rupture. Secondary end-point will be re-rupturing, time off work, sporting activity post rupture, functional outcome by Leppilahti score and patient satisfaction. Patient follow-up will be 12 month. Discussion: By making this design study we wish to contribute to more profound research on AT rupture treatment and prevent publication bias for this open-labelled randomized trial. Trial registration: ISRCTN50141196 Traditionally open surgical repair of a ruptured Achilles Background Controversy continues with regard to the optimal treat- tendon has been the first choice of treatment due to low ment for acute subcutaneous Achilles tendon (AT) rup- re-rupture rates and the possibility for functional post- tures. Treatment can be classified into operative (open or operative splintage [1-4]. But, 34% of patients treated minimally invasive/percutaneous) and non-operative. with open repair suffer from complications other than re- Post operative splintage can be divided into cast immobi- rupture, especially wound infection and adhesions [1-5]. lisation and functional bracing. In general, the outcome after treatment of a re-rupture is poor, but results following treatment of a deep infection Page 1 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 are devastating [6]. Therefore an effort should be made to Methods/Design prevent infectious complications. Many articles on differ- Design of study Context ent types of minimally invasive repair techniques (using limited incisions or performed percutaneously) of rup- The efficacy of minimally-invasive surgery versus func- tured AT's have been published [7-14]. But to date, only tional conservative treatment of acute subcutaneous two 2 randomized trials have been reported [4,15]. In Achilles tendon ruptures will be studied in a randomized Khan's review on randomized trials complications other trial. Four hospitals in the Netherlands will participate in than re-rupture were substantially reduced with percuta- the study, one of them being a university medical centre. neous repair techniques but data were very limited. Data The Medical Research Ethics Committee of all the partici- on complications using limited incision techniques are pating hospitals approved the study protocol. even more scant. As minimally invasive techniques differ it is hard to compare other techniques with these num- Patient selection and informed consent bers. An advantage of most minimally invasive techniques All patients who report to the emergency department of is smaller scars and less damage to the delicate blood sup- one of the participating hospitals with an acute Achilles ply of the AT. Importantly, in most patients minimally tendon rupture will be considered for entering the study invasive surgery does allow functional rehabilitation [7]. protocol. Inclusion and exclusion criteria are listed in Patients treated by functional rehabilitation after opera- table 1 and will be checked by an emergency room doctor, tion rather than cast immobilisation are reported to have surgical resident or surgeon. All eligible patients are asked a shorter in-patient stay, less time off work and a quicker to provide written informed consent. return to sporting activities. In addition, lower complica- tion rates, including re-ruptures, are reported [1-5]. Randomisation and concealment Randomisation is concealed by a specially designed inter- The main advantage of conservative, i.e. non-operative net site. Randomisation is in blocks (4 blocks) and strati- treatment is elimination of wound complications and fied by centre. The treatment nature is open labelled for intra-operative sural nerve damage. Complications other patients, physicians and physiotherapists. During follow- than re-rupture are reported to reduce to 3% [5]. But, con- up visits physical examination reveals the allocated treat- servative treatment with cast immobilisation has shown ment to patient and assessor. to increase the re-rupture rate [1,5] and cast immobilisa- tion induces delayed recovery due to calf muscle weakness Interventions as a result of long immobilisation of the ankle joint. In Surgical therapy consists of a minimally invasive tech- contrast, conservative treatment by functional bracing nique (Figure 1) [7]. The same protocol for the operative does allow immediate weight bearing, preventing calf procedure was used by all surgeons and residents in the muscle weakness and enabling fast recovery. In three stud- participating hospitals. Also, before study participation all ies conservative treatment of AT rupture with functional surgeons were familiar with the operative procedure. A bracing did not result in increased re-rupture rates [16- less than 5 cm longitudinal incision is made over the pos- 18]. But since only one of these is a randomized trial [17], terior aspect of the affected leg just proximal to the rupture more high quality data from randomized prospective site. The incision is slightly medially placed. The subcuta- studies is needed. We hypothesized that compared to sur- neous fat is divided and the peritendineum opened. Then gical treatment, conservative treatment with functional a Bunell type suture is placed though the proximal end of bracing will reduce the absolute risk of complications the Achilles tendon (PDS 1.0). With a hollow mandarin other than re-rupture with 30%. the suture is tunnelled to the lateral aspect of the calcaneal bone and guided out through a 5 mm stab incision. A hole is drilled through the calcaneal bone 1 cm distal to the tendon insertion (exit through 5 mm stab incision medi- Table 1: Inclusion and exclusion criteria Inclusion Criteria Exclusion criteria Achilles tendon rupture. Re-rupture/bilateral rupture/open rupture. Treatment starts within 72 hours. Combination with fracture of foot or ankle. Diagnoses by physical examination: palpable gap and calf muscle squeeze Former application (injection) of local corticosteroids in tendon area. test. Age 18–65 years. Contra-indications for surgery. Written informed consent. Physical or mental handicaps that do not allow functional treatment or otherwise interfere with the ability to follow-up on the study protocol. Page 2 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 Vacoped Figure 2 Vacoped. Vacoped bracing system (Company OPED, Valley, Ger- many) is a multifunctional splint consisting of several components. The essential parts are the dorsal and ventral shell, the vacuum cushion with changeable terry cloth covers, the belts with security locks and the removable sole. Prior to study use the brace was successfully used in Surgical repair technique Figure 1 a small pilot series and an instructions meeting on brace Surgical repair technique. Taken from [7]. application was held in all participating hospitals. In the first two weeks the brace is fixed in 30° plantar flexion. ally). The PDS in guided though the hole. Now the man- The following 2 weeks in is in rigid 15° plantar flexion. darin is used to guide the suture back to the proximal site The last two weeks the brace is dynamic from neutral posi- of the tendon. After the foot is placed in plantar flexion tion to 30° plantar flexion. Full weight bearing is allowed the suture is tied. After wound closure a cast is applied during the 6 weeks of bracing, not allowing sporting activ- with the foot still in plantar flexion. After one week a tape ities or walking stairs on tiptoes. Crutches are advised in bandage is applied for a total period of 6 weeks. In the first the first week of casting, thereafter for maintenance of bal- two weeks the tape bandage is supported by a 2 cm heel ance, but only if necessary. raise. The following 2 weeks the heel raise is reduced to 1 cm. The last two weeks the heel raise is removed (tape After tape or brace removal patients were advised further bandage will be renewed every time the heel raise is rehabilitation with physiotherapist and were allowed changed). Full weight bearing is allowed during the 6 sports 3 months after rupture. Patients were free to choose weeks of tape bandage, not allowing sporting activities or their physiotherapist. walking stairs on tiptoes. Crutches are advised in the first week of casting, thereafter for maintenance of balance, but Design of collection of data Primary endpoint only if necessary. complications other than re-rupture, i.e. infection, dis- Conservative therapy consists of a cast in plantar flexion turbed wound healing, sural nerve injury, scar adhesions, for one week. After one week a functional bracing system deep vein thrombosis and all other complications per (Vacoped, Figure 2) [19] is applied for 6 weeks. The treatment group. Page 3 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 During follow-up all complications will be documented moments of follow-up. Differences between groups for by a surgeon or resident according to a standardised pro- the number of complications and distribution of other cedure using the definitions of complications presented in endpoints will be calculated for each outcome measure the Table 2. All complications will be included in the final with a 95% confidence interval. The study groups will be analysis of results. compared with the chi-square test for categorical outcome variables and the independent sample Student t test for Secondary endpoint continuous outcome variables. The dropouts and with- re-rupturing (clinical diagnosis supported by ultrasound), drawals will be summarized and analyzed by treatment time off work, sporting activity post rupture and patient groups. A listing of subject with withdrawal with the date satisfaction. The Thompson test is used for clinical diag- and reasons for termination will be provided. nosis of re-rupture. Failure in plantar movement of the foot during calf muscle squeeze is considered a positive Because we standardised the intevention procedures we sign for re-rupture. Ultrasound evaluation for re-rupture is do not anticipate important differences between centers. performed in neutral ankle position. Complete tendon So we do not stratify our primary analysis for center. How- rupture with tendon gap was considered a re-rupture. ever, when eventually differences may occur we will Time off work will be registered by a patient diary. Com- explore their effect in a secondary analysis (Mantel-Haen- plete return to profession was used as endpoint. Stratifica- szel). All analysis in SPSS (SPSS Inc, Chicago Illinois). tion to type of profession (sedentary and non-sedentary) Sample size will be performed afterwards. A visual analogue scale (VAS) on patient satisfaction with treatment will be meas- Sample size is calculated on the basis of complication ured at 7 weeks, 3 and 12 month. Patient outcome will other than re-rupture. With conservative treatment using also be evaluated by the Leppilahti scoring method, a clin- this new type of functional bracing we hypothesized a ical scoring system, including subjective assessment of 30% reduction in the absolute risk for complications symptoms and evaluation of ankle range of motion and other than re-rupture. This risk reduction is similar to the isokinetic measurement of ankle plantar flexion and dor- risk reduction obtained in the systematic review on open sifexion strengths (Table 3) [20]. versus conservative treatment by Khan: risk of complica- tions for open repair being 34% [5]. Prospective data on Follow-up the risk of complications of minimally invasive repair is Follow-up visits for assessment of primary and secondary very scant. The Khan review provides the best empirical endpoints will be scheduled every week during the first 7 estimate for the complication risk associated with surgical weeks. Thereafter, follow-up visits will be planned at 3, 6 repair. Therefore we decided to use this risk estimate of and 12 month. Any other consultation for complaints complications of open repair for the sample size calcula- concerning the Achilles tendon area will be documented. tion. With a one-sided α of 0.05, a statistical power of (1- β) of 0.80, and an attrition rate of 10% we need to rand- Design of analysis omize at least 36 patients per treatment arm. Results will be analysed according the intention tot treat principle. Discussion This study is primarily designed to evaluate the effective- Data analysis ness of conservative treatment of acute AT ruptures, using The study groups will be compared for their baseline char- a functional bracing system, in reducing complications acteristics. The number of complications will be calcu- other than re-rupture. A comparison is made between this lated for the primary endpoint. Distribution measures will functional bracing system and a minimally invasive oper- be calculated for the secondary endpoints at the different ative repair of acute AT ruptures. Both treatment options Table 2: Definitions of complications used during follow-up. Complication Definition Infection Clinical signs of wound infection, i.e. redness, swelling, pain and functional impairment. Deep infection is defined as an infection beyond skin or subcutaneous fat needing surgical treatment in the operating theatre. Disturbed wound healing Keloid formation or hypertrophic scar, secondary wound healing, protruding PDS knot. Sural nerve injury Any sign of altered sensibility in the sural nerve area diagnosed by surgeon or surgical resident (using touch and pin prick test). Scar adhesion Clinical signs of adhesion of skin to underlying tissue layers. Clear wound retraction at ankle movement. Deep vein thrombosis Clinical and ultrasonographic signs of deep vein thrombosis of the ipsilateral lower leg. Other complications Any complication met during follow-up. Page 4 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 Table 3: Leppilahti score. Clinical factors Scores (points)* Pain None 15 Mild, no limitations on recreational activities 10 Moderate, limitations on recreational, but not daily activities 5 Severe, limitations on recreational and daily activities 0 Stiffness None 15 Mild, occasional, no limitations on recreational activities 10 Moderate, limitations on recreational, but not daily activities 5 Severe, limitations on recreational and daily activities 0 Calf muscle weakness (subjective) None 15 Mild, no limitations on recreational activities 10 Moderate, limitations on recreational, but not daily activities 5 Severe, limitations on recreational and daily activities 0 Footwear restrictions None 10 Mild, most shoes tolerated 5 Moderate, unable to tolerate fashionable shoes, modified shoes tolerated 0 Active range of motion (ROM) difference between ankles Normal (<6°) 15 Mild (6°–10°) 10 Moderate (11°–15°) 5 Severe (>15°) 0 Subjective result Very satisfied 15 Satisfied with minor reservations 10 Satisfied with major reservations 5 dissatisfied 0 Isokinetic muscle strength (score) Excellent 15 Good 10 Fair 5 poor 0 * Maximum overall score 100. An overall score of 90–100 rates excellent, 75–85 is good, 60–70 is fair and <55 is poor. used in this comparison allow immediate full weight lem of publication bias, i.e. selective publication of posi- bearing so none of the patients is denied the purported tive associations and disregarding negative and weak advantage of a functional after treatment [2,5,21-24]. associations, prevent unnecessary duplication of research efforts and duplicate publication [25]. To our knowledge, There have been randomized clinical trials on treatment there has never been a design study published regarding of acute Achilles tendon rupture but the methodological treatment of AT ruptures. By making this design study we rigour is often low. There is a need for more rigorous wish to contribute to more profound research on AT rup- designed studies on AT rupture treatment as this subject is ture treatment and prevent publication bias for this open- still very much under debate. By publishing our protocol labelled randomized trial. we wish to show our care for a profound design and meth- odological quality of our protocol. Moreover, when the Competing interests design of a study is published it will help to achieve trans- The author(s) declare that they have no competing inter- parency about why and how studies are undertaken. The ests. publication of a study design may help to reduce the prob- Page 5 of 6 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:108 http://www.biomedcentral.com/1471-2474/8/108 19. Meyer T, Meyer J, Scola E: Achilles tendon rupture. Operative Authors' contributions tendon suture and semifunctional aftercare with vacuum RM main author of study design. brace system (Vacoped). Chir praxis 1998, 54:101-8. 20. Leppilahti J, Forsman K, Puranen J, Orava S: Outcome and prog- nostic factors of Achilles rupture repair using a new scoring GK first initiated the trial and participated in designing the method. Clin Orthop 1998, 346:152-161. treatment protocol for operative and non-operative treat- 21. Kangas J, Pajala A, Siira P, Hamalainen M, Leppilahti J: Early func- tional treatment versus early immobilization in tension of ment. the musculotendinous unit after Achilles rupture repair: A prospective, randomized, clinical study. J of Trauma: Injury, Inf EV first initiated the trial. Especially involved in all clinical and Crit Care 2003, 54:1171-81. 22. Kerkhoffs GM, Struijs PA, Raaymakers EL, Marti RK: Functional aspects of the trial and study design. treatment after surgical repair of acute Achilles tendon rup- ture: wrap vs walking cast. Arch Orthop Trauma Surg 2002, GH contributed to methodology of the study design. 122:102-5. 23. Maffulli N, Tallon C, Wong J, Lim KP, Bleakney R: Early weightbear- ing and ankle mobilization after open repair of acute mid- All authors read and approved the final manuscript. substance tears of the achilles tendon. 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Saleh M, Marshall PD, Senior R, MacFarlane A: The Sheffield splint for controlled early mobilisation after rupture of the calca- available free of charge to the entire biomedical community neal tendon. A prospective, randomised comparison with peer reviewed and published immediately upon acceptance plaster treatment. J Bone Joint Surg Br 1992, 74(2):206-209. 18. McComis GP, Nawoczenski DA, DeHaven KE: Functional bracing cited in PubMed and archived on PubMed Central for rupture of the Achilles tendon. J Bone Joint Surg Am 1997, yours — you keep the copyright 79(12):1799-1808. BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 6 of 6 (page number not for citation purposes)

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BMC Musculoskeletal Disorders – Springer Journals

Published: Nov 6, 2007

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