Evaluation of the Treatment of Idiopathic Clubfoot by Using Modified Method: A Prospective Study

Med. J. Cairo Univ., Vol. 77, No. 4, June: 23-236, 2009 www.medicaljournalofcairouniversity.com Evaluation of the Treatment of Idiopathic Clubfoot by Using Modified Method: A Prospective Study KHALED S. SALAMA, M.D. The Department of Orthopedic Surgery, Faculty of Medicine, Suez Canal University. Abstract A new modified combined method of management of talipes equinovarus was designed to overcome the complication of aggressive surgical techniques and failure of pure conservative methods. French method of conservative treatment in idiopathic congenital clubfoot in first two months then complete posterior release were the technique followed in a prospective study consisting of 2 infants (38 feet) starting treatment at first week of life not more. Average follow-up was 30 months (range from 24 to 32 months). Seventeen of our patient (8%) and 34 feet out of 38 (89.5%) clubfeet were corrected without requiring medial release. All patient required medial release were presented with bilateral affection (4 out of 7=23.5%), also all of them were males with highly significant relationship between bilateral affection and sex and relapse of treatment. The results show that careful adherence to the treatment protocol and an improved understanding of the pathologic anatomy can result in similar rates of successful outcomes to those achieved by other authors. Key Words: Talipes equinovarus Clubfoot French method. Introduction CONGENITAL idiopathic talipes equinovarus (CTEV), or clubfoot deformity, is used to describe a complex deformity that occurs in otherwise generally healthy infants. It consists of 4 components: equines, varus, adductus, and cavus. It is generally agreed that the initial treatment should be nonsurgical and start as soon as possible after birth. According to the World Health Organization (WHO), the incidence of CTEV varies from 0.42 to 0.85 per thousand live births. This wide variation in incidence may be explained by the inclusion of minor postural deformities with true structural deformities. A more accurate figure for Europe is 6.4 per 0000 live births, in Africa the incidence is higher, 5 per 0000 [,2]. Thus, this is a common pediatric foot deformity, and its treatment has significantly changed over the last two decades. Forceful manipulation under general anesthesia leading to a small rigid spuri- ously corrected foot has been superseded by the gentle repetitive manipulation of the foot to achieve gradual reduction of the malaligned joints [3]. A variety of manipulations, splinting, strapping, bracing, and casting techniques have been advocated in an attempt to achieve correction of the deformity, although some success with nonsurgical treatment has been reported in the literature, results have often been less than optimal, with partial corrections, recurrence, and other complications. This has led to a trend toward surgical intervention, usually within the first year of life. However, surgical treatment also carries significant risks, and the potential for complications is great [4,5]. Most orthopedic surgeons will agree that the initial treatment of a patient with clubfoot when presenting early in life should be conservative [6,7], we have been using our new strategy in managing all cases of TEV which must be started in first week of life. Material and Methods The study was carried out in patients having classical idiopathic clubfeet who were not more than one week of life attending the orthopaedic clinic of our university hospital from June 2004 through May 2005. Older patients or those having non-idiopathic deformities were excluded from the study. Of the 29 patients (52 feet) selected for the study, eight patients were lost to follow-up and hence were excluded from the study leaving 2 patients with 38 feet. Infants were evaluated and graded for severity by using the Dimeglio scale (Table ) [8]. Grading was performed to establish the severity of the deformity before treatment. In this system, 4 parameters are considered to be important: equinus deviation in the sagittal plane, varus deviation in the frontal plane, derotation of the calcaneo-forefoot block in the horizontal plane 23

232 Clubfoot Treatment of Idiopathic (supination), and adduction of the forefoot relative to the hindfoot in the transverse plane. These 4 parameters are assessed for reducibility by applying gentle corrective pressure to the foot. Each parameter is then scored on a 4-point scale: reducibility 90º to 45º, 4 points; 45º to 20º, 3 points; 20º to 0º, 2 points; and 0º to -20º, point. When tested, all 4 parameters can lead to a maximum of 6 points. Four additional elements are also evaluated, and point is added to the score if they are present. These include the presence of a medial crease, and the presence of posterior crease, and the existence of planter retraction or cavus deformity; point was added for poor muscular condition, such as hypertonic, fibrous or contracted triceps, tibialis anterior, or peroneal tendons [8]. Those infants with reducible clubfoot deformity at birth were excluded. Chart review was used to determine the number and timing of treatments. Patients were evaluated every to 2 months after completion of initial treatment until 30 months of age to encourage parental compliance with the straight last shoes and foot abduction bar and to evaluate maintenance of the correction. The minimum follow-up for patients included in this study was 2 years. Criteria for successful outcome were defined as ankle joint dorsiflexion >0º, and a plantigrade foot without heel varus. A plantigrade foot was defined as one with the rearfoot and forefoot (all 5 metatarsal heads) in contact with the ground in stance. Heel varus was defined as any degree of inversion of the calcaneus compared with the long axis of the tibia in stance [8,9]. Treatment protocol: Patients were treated as soon as possible after birth (from first day and not after 7 th day). The course of the treatment divided into two main parts, the first part is the conservative part (from first day to two month of age) and the second part is the surgical part. First part of treatment: Is the conservative part which depends mainly on the French Physiotherapy (Functional) Method, with some modification regarding the timing of sessions, we decide to make it every two days from the beginning of treatment not each day. The French method was conceived in the early 970s by Masse and by Bensahel and colleagues, known as the "Functional Method", it depend on stimulation of muscles around the foot (particularly the peroneal muscles) to maintain the reduction achieved by passive manipulations, and temporary immobilization of the foot with nonelastic adhesive strapping [,5,0,]. The French method aims specifically at relaxing the tibialis posterior and medial fibrous zone through a combination of progressive passive manipulations, active muscle work, and strapping. The infant must be relaxed; otherwise resistance makes this technique difficult. Sessions last approximately 30 minutes per foot. The process is no more difficult but must be well assimilated because it is detailed and very precise in all of its steps, including finger placement, hand position, and sensing of the infant response. Manipulations are performed gently and smoothly and must be progressive in reduction of the deformities. The first weeks of life are the best time to initiate the functional treatment because it allows the best chance of success. The goal of this treatment is to reduce the talonavicular joint, stretch out the medial tissues, and then sequentially correct forefoot adduction, hindfoot varus, and equinusof the calcaneus. In the first step, the navicular bone is progressively released from the medial malleolus and from its medial position on the head of the talus. Early on, this relaxation will be incomplete because the talus retains its pathologic position. Gradually, this improves. The second step is to correct forefoot adduction by stabilization of the global adduction of the calcaneus-forefoot block. This maneuver stretches all the joints of the medial ray of the foot progressively: naviculo-cuniform, cuneiform-metatarsal, and MTP. As this is performed and after all joints of the foot have been loosened, forefoot adduction is further decreased by continuing to stretch the medial skin crease. To maintain the new passive range of motion, we strengthened the toe extensors and peroneals muscles by eliciting cutaneous reflexes through tickling the fifth ray and along the lateral border of the foot. The third step is progressive reduction of hindfoot varus. This begins after the talonavicular joint has been reduced and can be performed in conjunction with correction of the forefoot adduction. The calcaneus gradually moves to a neutral position and eventually into valgus. The ankle is externally rotated at the same time that the calcaneus is being mobilized into valgus. The knee is kept flexed to 90º during these maneuvers. The fourth step of this treatment program corrects the equinus of the calcaneus, which is often difficult because contracture of the posterior soft tissues may not be easily elongated by manipulations. The calcenus is progressively brought from planter flexion to dorsiflexion while the knee is kept in

Khaled S. Salama 233 flexion. The knee is then very cautiously extended. This maneuver is performed repeatedly. The lateral arch is carefully supported in an effort to protect the midfoot from being stretched (midfoot break). The fifth step. Once the manipulations are concluded, taping is applied to maintain the passive range of motion achieved during the session. Elastoplast tape holds the foot in position but, because it stretches, permits exercise of the tapped foot [3]. Second part of treatment: Steps of the surgical comprehensive procedure used in our research are as following: - Prone position allows better assessment of the hindfoot correction. 2- Longitudinal incision about 3 cm direct on tendoachilis, ended at its calcaneal insertion. 3- As in any procedure involving multiple anatomic steps, exposure is the key to a successful comprehensive release, and there is no better place to begin emphasis of exposure than with the posterolateral corner of the ankle, where after the sural nerve and lesser saphenous vein have been identified and protected, the peroneal sheath is opened to allow full anterior retraction of the two tendons. This permits a precise and complete release of the calcaneofibular and lateral subtalar ligaments anteriorly to the sinus tarsi area under direct vision; therefore avoid blind peroneal tendon injury. 4- The opening of the tendon sheath ends above the tip of the fibula to avoid subluxation of the tendon anterior to the fibula. 5- Longitudinal exposure of the Achilis tendon permits a long Z-lengthening in either the coronal or sagiattal plane, so that two strips are created for later competent repair under tension. 6- The flexor hallucis longus sheath medially is opened so that the tendon can be retracted. Posterior and medial release of the subtalar and tibiotalar joints done at this stage. 7- Skin closure is done with minimal tension to avoid necrosis of the skin edges. If the original deformity was severe, the foot must must left with residual equinus in the immediate postoperative cast and cast changed to a new one after 0 days (usually under anesthesia) to correct the residual equinus once the wound has healed (we used above knee cast) [8,2]. Immobilization of freshly operated patients is as important as the operative procedure itself. We hold the tibia and fibula unit in internal rotation by grasping just distal to the knee and externally rotating the foot against the tibia-fibula position while the plaster hardens. Additional molding against the first metatarsal medially helps correct forefoot adduction and additional molding against the cuboid planter surface everts the midfoot. I changed the cast after 6 weeks for two to four times according to judgment about the improvement and correction of the foot, then using AFO or abduction bar and or straight-last shoe according to patients needs. The patients were followed-up every month after finishing the initial treatment protocol, for the first year and every 2 months subsequently to assess range of motion, function and appearance of the ankle and foot. The statistical analysis was done using SPSS (Version 2.0). Results were expressed as the mean and standard deviation (SD). A chi-square test and an unpaired t-test were applied for statistical analysis. The statistical difference was considered to be significant when p<0.05 and highly significant when p<0.00. Results The age at initial presentation ranged from day to 7 days. Average follow-up was 30 months (range 24 to 32 months). Table (): Dimeglio classification of clubfoot. Essential parameters: the examiner applies a gentle corrective force and records: Equinus deviation in the saggital plane (0 to 4 points) Varus deviation in the frontal plane (0 to 4 points) Derotation of the calcaneo-forefoot block (0 to 4 points) Forefoot adduction in the horizontal plane (0 to 4 points) Further pejorative elements: Posterior crease ( point) Medial crease ( point) Cavus ( point) Poor muscle condition ( point) Overall total score (0 to 20 points) Scoring: reducibility (equinus, varus, calcaneo- forefoot block derotation, and forefoot adduction): 90º to 45º 4 points 45º to 20º 3 points 20º to 0º 2 points 0º to -20º point <-20º 0 points Grades: Overall total score Grade : Benign feet 0 to 5 points Grade 2: Moderate feet 5 to 0 points Grade 3: Severe feet 0 to 5 points Grade 4: Very severe feet 5 to 20 points

234 Clubfoot Treatment of Idiopathic Table (2): Criteria of all patients included in our study. Patient Sex Affected side Right foot Left foot Age at Treatment onset (days) No. of casts required postoperative Length of follow-up (months) Clubfeet requiring medial release M Right 6 4 30 0 2 M Bilateral 7 7 4 30 0 3 M Bilateral 2 2 3 28 0 4 F Right 6 3 24 0 5 F Bilateral 7 0 7 4 29 0 6 M Left 3 3 3 32 0 7 F Left 2 5 2 3 0 8 M Bilateral 0 0 6 2 32 0 9 M Bilateral 7 7 6 2 28 0 0 M Bilateral 9 7 2 3 25 M Bilateral 3 3 4 3 24 0 2 M Bilateral 8 3 5 3 27 0 3 F Bilateral 0 0 2 29 0 4 M Bilateral 0 0 3 3 30 0 5 M Bilateral 6 2 3 30 6 M Bilateral 6 4 3 30 7 F Bilateral 0 0 5 2 29 0 8 M Bilateral 6 6 3 30 9 M Bilateral 2 2 3 30 0 20 M Bilateral 0 0 2 28 0 2 M Bilateral 7 6 2 26 0 Table (3): Relation between dimeglio score and number of casts required postoperative. right left r value **: Correlation is significant at the 0.0 level. * : Correlation is significant at the 0.05 level. No. of casts p value.730 (**).000.558 (*).020 Table (4): Relation between and clubfeet requiring medial release. right left Mean.47.5 Clubfeet 0 Std. deviation Mean 3.064 3.00 2.375 5.00 Std. p deviation value 3.559.393 2.708.05 Table (5): Relation between and length of follow-up. right left Length of follow-up r value.352 -.3 p value.8.67 Tables (6,7): Showed relationship between affected side and sex, and clubfeet requiring medial release. Affected side: Bilateral Left Right Male Sex Female Total N % N % N % 4 87.5 6.3 3 6.3 60.0 20.0 20.0 7 2 2 8.0 9.5 9.5 Total: p=0.393 6 00.0 5 00.0 2 00.0 Clubfeet: 0 2 4 75.0 5 25.0 0 00.0.0 7 4 8.0 9.0 Total: p=0.304 6 00.0 5 00.0 2 00.0

Khaled S. Salama 235 Table (8): Relationship between affected side and clubfeet requiring medial release. Affected side Bilateral Left Right Total N % N % N % N % Clubfeet: 0 3 76.5 2 00.0 2 00.0 7 8.0 4 23.5 0.0 0.0 4 9.0 Total: p=0.559 7 00.0 2 00.0 2 00.0 2 00.0 Average of right side of cases who are corrected by our technique was.47 (±3.064), left was.5 (±2.375). Regarding the cases required medial release average Dimeglio score of the right side was 3 ( ±3.559), left was 5 (±2.708). These results emphasized that there are significant relationship between at initial presentation and end results. showed significant relationship between high scores and all of the results like length of follow-up, number of casts required, and cases required medial release. Discussion The deformity known as clubfoot is probably the most common congenital orthopedic condition required intensive medical treatment. It most likely represents congenital dysplasia of all musculoskeletal tissues (musculotendenious, ligamentous, osteoarticular, and neurovascular structures) distal to the knee [3]. Manipulation and holding the foot in corrected position (with the help of resinous cerate) was identified as early as 400 BC by Hippocrates. Several indigenous casting methods have evolved in the past based on pure logic to undo the deformity by producing the force in the opposite direction and reporting success rates varying from 5%- 90%. The huge percentage difference indicates a lack of a standard technique for manipulation and casting [6]. Probably Kite was the most precise in describing his technique of manipulation and casting and reported a success rate of 90% in his patients when treatment was started before year of age, and the duration of cast treatment ranged from 26-49 weeks. However, when used by other orthopedic surgeons, this method resulted in low correction and a high relapse rate. It was reported that surgery could be avoided only in 20% to 50% of patients treated by Kite s method. Since 2002, several studies have surfaced demonstrating the successful use of the Ponseti method in clubfoot correction [7,8,3] so much so that the method is becoming an accepted treatment of idiopathic clubfoot all over the world. Laaveg and Ponseti reported that 90% of their patients were satisfied with the function and appearance of their feet on long-term follow-up (average 9 years) [3]. Some of these patients who were followed up for 30 years showed no deterioration of the function or appearance of the feet. Regardless of the treatment given, a clubfoot deformity tends to relapse until the child is about 7 years of age [4,5]. Although nothing can be said with certainty about the cause of relapse in our series, we doubt the compliance of the parents with using the foot abduction bar or night braces due to the low level of literacy and social factors affecting their families. Difficulty can be encountered in maintaining compliance with orthosis wear. Every effort should be made to assist families in this endeavor because lack of compliance with brace wear is the primary reason of recurrence of deformity and failure of this treatment method. Although there remains some controversy in the literature, we speculate that the tendency to relapse may be caused by the intrinsic contractile nature of the soft tissues in the clubfeet deformity as postulated by Ponseti and others [,4,6,7,8]. In study published by Sud and his colleagues (2007), they emphasized that there is no relationship between age and sex and end results. They compared the Ponseti and Kite methods, our results were nearly the same as Ponseti in this article, he got about 90% successes (our result was 89.5%). We are of the opinion that Ponseti method is superior to Kite method and our results were nearly equal to Ponseti. The results of treatment with Ponseti method depend both on the outcome parameter used to judge results and on length of follow-up. Most current studies report high degree of success over short term. Long term studies report recurrence of deformity in about one third of feet? [4,9,3,4,9,20]. The results of treatment with French physiotherapy method were first reported by Bensahel and associates in 990 [0]. Good results were attained in nearly 50% of patients. When complementary surgery was performed in the remaining patients, the overall good outcome increased to 86%. So we added posterior surgical release in early treatment to attend good results (89.5%).

236 Clubfoot Treatment of Idiopathic Limitations of this study include subjective evaluation of examiner, although efforts were made to address this by using standard scoring system for initial evaluation, and measurement criteria for successful outcome. Short period of follow-up and small number of patients is additional limitations to this study. Conclusion: Our results show that careful adherence to the treatment protocol and an improved understanding of the pathologic anatomy can result in similar rates of successful outcomes similar to those achieved by other authors. The treatment process is simple and effective. In the majority of cases, the need of medial release is obviated and potential complications are avoided. Assessment plays a vital role in the management of clubfoot but current methods (clinical, functional and radiological) are sub-optimal. Limited research has been undertaken assessing the role of biomechanical assessment. Both foot pressure and gait analysis have been shown to be objective, functional and quantitative methods of assessment and can provide valuable information to aid the assessment of the deformity and management. It is thought that in the future, new classification criteria will incorporate certain aspects of gait and pedobarographic data to allow complete assessment. References - HERRING J.A. (ed): Congenital talipes equinovarus (clubfoot) in Tachdjian s paediatric orthopaedics, vol. 2, 3rd edn. Philadelphia, Saunders, p 927, 2002. 2- SCHER D.M.: The ponseti method of treatment of clubfoot. Curr. Opin. Pediatr., 8 (): 22-28, 2006. 3- PONSETI I.V.: Treatment. Congenital clubfootfundamentals of treatment. New York; Oxford University Press, pp 6-8, 996. 4- HAASBEEK J.F. and WRIGHT J.G.: A comparison of the long-term results of posterior and comprehensive release in the treatment of clubfoot. J. Pediatr. Orthop., 7: 29-35, 997. 5- SCARPA A.: A memoir on the congenital club feet of children, and the mode of correcting that deformity. 88 Clin. Orthop., 308: 4-7, 994. 6- KITE J.H.: The treatment of congenital clubfoot. Surg. Gynaecol. Obstet., 6: 90-200, 935. 7- PONSETI I.V.: Common Errors in the treatment of congenital clubfoot. Current Concepts, Int. Orthop. (SICOT), 2: 37-4, 997. 8- DEMEGLIO A., BENSAHEL H., SANCHET P., et al.: Classification of clubfoot. J. Pediatr. Orthop. (B), 4: 29-36, 985. 9- DIMEGLIO A., BONNET F. and MAZEAU P.: Orthopeadic treatment and passive motion machine: Consequiencess for the surgical treatment of clubfoot. J. Pediatr. Orthop. B., 5: 73, 996. 0- BENSAHEL H., CATERRALL A. and DIMEGLIO A.: Practical application in idiopathic clubfoot; a retrospective multicenter study in EPOS. J. Pediatr. Orthop., 0: 86, 990. - McKAY D.W.: New concept of approach to clubfoot treatment. Section -Principles and morbid anatomy. J. Pediatr. Orthop., 2 (4): 347-356, 982. 2- CARROLL N.C. and GROSS R.H.: Operative management of clubfoot. Orthopedics, 3: 285-296, 990. 3- HERZENBERG J., RADLER C. and BOR N.: Ponseti versus traditional methods of casting for idiopathic clubfoot. J. Pediatr. Orthop., 22: 57-52, 2002. 4- BEYAERT C., HAUMONT T. and PAYSANT J.: The effect of inturning of the foot on knee kinematics and kinetics in children with treated idiopathic clubfoot. Clin. Biomech. (Bristol, Avon), 8: 670, 2003. 5- MILLER J.H. and BERNSTEIN S.M.: The roentgenographic appearance of the "corrected clubfoot". Foot Ankle, 6: 77-83, 986. 6-APPLINGTON J.P. and RIDDLE C.D.: Avascular necrosis of the body of the talus After combined medial and lateral release of congenital clubfoot. South Med. J., 69: 037-038, 976. 7- ARONSON J. and PUSKARICH C.L.: Deformities and disabilities from treated club foot. J. Pediatr. Orthop., 0 (): 09-9, 990. 8- BLAKESLEE T.J.: Congenital idiopathic talipes equinovarus (clubfoot). Current concepts Clin. Podiatr Med. Surg., 4: 9-56, 997. 9- DAVIES T.C., KIEFER G. and ZERNICKE R.F.: Kinematics and Kinetics of the hip, knee, and ankle of children with clubfoot after posteromedial release. J. Pediatr. Orthop., 2: 366, 200. 20- CUMMINGS R.J.: Letter to editor. J. Bone Joint Surg., 84-A (0): 890, 2002.