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Congenital clubfoot treatment continues to be controversial particularly in a resource-constrained country. Comparative evaluation of clubfoot surgery with Ponseti methods has not been reported in West Africa.
To determine the effects of Ponseti techniques on clubfoot surgery frequency and patterns in Nigeria.
This was a prospective hospital-based intention-to-treat comparative study of clubfoot managed with Ponseti methods (PCG) and extensive soft tissue surgery (NPCG). The first step was a nonselective double-blind randomization of clubfoot patients into two groups using Excel software in a university teaching hospital setting. The control group was the NPCG patients. The patients' parents gave informed consent, and the medical research and ethics board approved the study protocol. Biodata was gathered, clubfoot patterns were analyzed, Dimeglio-Bensahel scoring was done, the number of casts applied was tallied, and patterns of surgeries were documented. The cost of care, recurrence and outcomes were evaluated. Kruskal-Wallis analysis and Mann-Whitney U technique were used, and an alpha error of < 0.05 at a CI of 95% were taken to be significant.
We randomized 153 clubfeet (in 105 clubfoot patients) into two treatment groups. Fifty NPCG patients (36.2%) underwent manipulation and extensive soft tissue surgery and 55 PCG patients (39.9%) were treated with Ponseti methods. Fifty-two patients of the Ponseti group had no form of surgery (94.5% vs. 32%, p<0.000). Extensive soft tissue surgery was indicated in 17 (34.0%) of the NPCG group, representing 8.9% of the total of 191 major orthopaedic surgeries within the study period. Thirty-five patients (70.0%) from the NPCG group required more than six casts compared to thirteen patients (23.6%) of the PCG (p<0.000). The mean care cost was high within the NPCG when compared to the Ponseti group (48% vs. 14.5%, p<0.000). The Ponseti-treated group had fewer treatment complications (p<0.003), a lower recurrence rate (p<0.000) and satisfactory early outcome (p<0.000).
Major clubfoot surgery was not commonly indicated among patients treated with the Ponseti method. The Ponseti clubfoot technique has reduced total care costs, cast utilization, clubfoot surgery frequency and has also changed the patterns of surgery performed for clubfoot in Nigeria.
Divergent views exist as to what proportion of clubfeet may be successfully managed by closed non-operative methods and how long an orthopedic surgeon should persist in non-operative treatment if the appearance of the foot does not improve.1 In Nigeria, clubfeet often present for treatment beyond twelve weeks of age, with persistent deformity that is unlikely to yield to manipulation. The orthopedic clinical treatment choices for an incompletely corrected clubfoot are more difficult when the parents and patients are already frustrated. Little progress had been made in treatments since surgical approaches were described in the early 1980s.2,3 Extensive early surgery did not prove to be of any real advantage and may have even been harmful. One point of agreement among experts has been that those clubfeet requiring multiple operations became stiff, were smaller and weaker than the contralateral foot, and that they functioned poorly in the long term.4 Competent surgical management of clubfeet should yield about 90% satisfactory results at skeletal maturity. In the context used here, good results imply a flexible, plantigrade foot with the ability to bear weight on the forefoot through strong gastrocneumius muscle contraction, minimal cavus and a slightly externally rotated foot-progression axis. When the re-operation rate is more than 5 to 10%, the surgical method employed requires re-evaluation.1
The effects of the Ponseti clubfoot technique on clubfoot surgery in Nigeria have not previously been reported. We comparatively evaluated the Ponseti method as it was introduced in the pattern of clubfoot surgeries performed in Nigeria. The research hypothesis was that no difference exists between the traditional methods of clubfoot treatment via extensive soft tissue/bony surgery and the Ponseti method. The outcome measures included frequency of major surgery, the number of casts applied, and total cost of clubfoot treatment.
All cases of consenting clubfoot were recruited, at any age, presenting with idiopathic, syndromic/asyndromic, unilateral or bilateral clubfoot, with or without previous treatment and/or post surgical recurrence. All clubfoot patients were enrolled and treated using either the Ponseti (Iowa) technique (PCG), or manipulation and extensive soft tissue/bony surgery (NPCG) within the study period. All patients with a minimum follow-up of three months post last casting were included. The following were documented: biodata, birth history, clubfoot pattern, body side, laterality (unilateral/bilateral), age at onset of treatment, mode of treatment offered, total numbers of casts applied, care cost (low or high) and treatment complications.
Clubfoot patients who were not primarily treated at, or operated upon at the participating institution were excluded. Also excluded were patients who had defaulted during treatment prior to the study's inception, or were discharged against medical advice, as well as those with acquired clubfoot.
Clubfoot patients were recruited into the study between October 1, 2007 and November 30, 2009 at the orthopaedics and antenatal clinics of the Obafemi Awolowo University Teaching Hospital Complex, He Ife, (OAUTHC) Nigeria.
All clubfoot patients were first seen and assigned to a study group by a voluntary chief nursing officer at the orthopaedic clinic who was blinded to the managing team and study protocol. A senior registrar and a consultant orthopaedic surgeon acted as blinded clinical outcome evaluators. Both the nursing officer and senior registrar/consultant orthopaedist scored the clubfeet independently using Dimeglio-Bensahel Severity Score. Any differences were reconciled before treatment and after completion of treatment at the last follow-up clinic. The voluntary chief nursing staff and blinded evaluators were not part of the study group. A consultant radiologist with seven years experience, with a neutral status in the study, screened the plain x-rays of patients and confirmed radiological features of clubfoot. The orthopedic managing teams were blinded to the clubfoot patient's selection, and surgical treatment methods chosen were not influenced. No clubfoot subjects had previously been exposed to Ponseti techniques.
A twenty-six month prospective, intention-to-treat, nonselective randomized, double-blind comparative study of clubfoot managed with Ponseti techniques (PCG) and non-Ponseti methods (NPCG) was undertaken. The clubfoot patients in the PCG and NPCG formed the study population.
The study protocol was approved by the institutional medical ethics review board. A written or informed consent from the patient's parents was obtained that fulfilled the inclusion criteria before randomization. The patient's parent's informed consents were obtained by video recording or photographs without facial covering with the understanding that after participation in the study, all results were to be used only for scientific meetings or publication. Written consents were not applicable for all of the patients' parents because of illiteracy.
The first step was a nonselective randomization of clubfoot patients into two groups (PCG and NPCG) using computer-generated random numbers (Excel 5.0). Both the assessors and patients/parents were blinded to the allocations and were not informed of the block size until after completion of the study on December 3, 2009. The patients who served as our control group were those in the NPCG group, and they were treated with manipulation and extensive soft tissue or bony surgery.
Non-Ponseti Clubfoot Group Management: This group (NPCG) received routine clubfoot manipulation and soft tissue (tendon and ligament) stretching at the orthopedic clinic. Clubfoot patient mothers were taught to do manipulation on their own and the patients were evaluated weekly. Robert Jones strapping,5,6 Denis Browne splints and Kite's7 methods were the non-operative treatments utilized. The clubfeet that failed these corrections ended up receiving extensive soft tissue/bony surgery. Prolonged physiotherapy was relied upon to correct most of the post surgical recurrences.
Ponseti Clubfoot Method Group Management: A description of the Ponseti method was documented earlier.8,9,10 The Ponseti clubfoot technique was introduced at our study center. This corrective method was explained to parents and adolescents. Manipulation was performed and retention casts were changed weekly. The manipulations performed lasted about 10 to 15 minutes. Long-leg casts were applied with the knee flexed to about 110-120 degrees. Correction of neglected idiopathic clubfeet by the Ponseti method was done with minimal modification.11 Casts were changed every two weeks to allow for remodeling of the soft tissues and osteocartilaginous structures. The foot was abducted to approximately 30 to 40 degrees instead of the 70 degrees recently recommended for younger children.12 Equinus was corrected via percutaneous tenotomy of the tendo-Achilles performed under local anesthesia using 3-5mls of 1% plain Lidocaine. The skin incision was closed with a single 3/0 Vicryl stitch.
The number of patients treated without extensive soft tissue surgery was viewed as the primary effect of the Ponseti technique on clubfoot surgery. The secondary outcome measures included the number of plaster casts above six, the cost of care and complications of treatment.
Clubfoot severity was graded using the Dimeglio-Bensahel classification.13 This incorporated eight components including equinus, varus, position of the talo-calcaneal forefoot unit (supination/pronation), forefoot adduction, the presence of abnormal musculature, cavus, a medial crease, and a posterior crease. A total of 20 points was possible; the higher the number, the more severe and rigid the clubfoot. Type I consisted of benign feet (0-5 points), Type Ha consisted of moderately affected feet (6-10 points), Type lib consisted of severely affected feet (11-15 points) and Type III consisted of very severely affected feet (16-20 points).
All patients had pre-treatment, post-correction and last follow-up plain radiographs that included anteropos-terior (AP) and lateral standing (LS) views of the feet. The talocalcaneal and talar/first metatarsal angles were obtained from the AP view. The talocalcaneal angle was recorded from the LS view. Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT) scans were excluded as assessment methods because both were not financially accessible for all clubfoot patients. A mobile phone was used to monitor patients' follow-up and to improve clinic compliance.
Any variations in clinical assessment were controlled by using a single sheet of paper containing comprehensive classifications and ratings for all patients. All plaster of paris retention casts were applied under the direct supervision of attending orthopaedic fellows to allow for consistency in casting and ratings.
In each orthopedic clinic, all feet were scored prior to application of each retention cast, surgery and/or placement of foot abduction orthoses. Percutaneous or open Achilles tenotomy was classified as a minor surgery. Extensive soft tissue surgery, anterior tibialis tendon transfer and/or posterior capsulotomy, and triple arthrodesis were documented as major clubfoot surgeries. A relapse was defined as the appearance of slight equinus and varus deformity of the heel, often without increased adduction or cavus deformities of the forefoot. The sum of the talocalcaneal angle in the AP and LS views (referred to as Beatson-Pearson index)13 was used to determine radiological outcome. Clubfoot treatment was judged as satisfactory if the Dimeglio-Bensahel score was ≤ 6 at the last follow-up clinic.
The cost of clubfoot treatment was judged as low when a patient received a maximum number of six casts with or without minor surgery. Individuals requiring more than six casts and/or major surgery were recorded as having a high cost of care for the purposes of this study.
All analyses were performed on the basis of the intention-to-treat cohort, defined as all clubfoot patients who received at least one form of clubfoot treatment within the study period. Data was analyzed using the Statistical Package for Social Sciences (SPSS) version 16.0 for Windows. The comparability of patients in the two groups of clubfoot treatment was determined from the demographic data and baseline values. The Kruskal-Wallis analysis was used for data generation. Changes in the mean hospital care cost and mean Dimeglio-Bensahel points were evaluated using two-way ANOVA for parametric data, and Mann-Whitney U technique was used to compare the two clubfoot groups for non-parametric data. A confidence interval (CI) of 95% p<0.05 was taken to be significant.
Within these two main groups, there were a limited number of clubfoot patients and a lack of long-term follow-up results for complications and functional evaluation.
153 clubfeet in 105 patients met the inclusion criteria representing 76.1% of congenital malformations. Fifty (36.2%) NPCG patients had manipulation and extensive soft tissue surgery, while 55 (39.9%) were treated with the Ponseti method. The number of PCG patients with congenital limb malformation that was managed was significant (p<0.000). The age at presentation was unique at 32 patients (58.2%) of the PCG group presenting before six months as compared to 14 patients (28%) of the NPCG group (p<0.024). The patient's age at presentation was not related to clubfoot etiology (p>0.077) and treatment complication (p>0.331). Also, no significant difference existed between the Dimeglio-Bensahel scoring severity of clubfeet in the two treatment groups as depicted in Table 1. In the Ponseti group, sixteen (29.1%) patients had previous treatment compared to 13 (26.0%) of the NPCG patients. At presentation, three (5.4%, 2 male, 1 female) of the Ponseti group patients had recurrent clubfoot post surgery. These were found in five feet at ages seven months, four years and 14 years.
The oldest patient in the Ponseti group was an 18-year-old girl with unilateral neglected clubfoot, Dimeglio-Bensahel type lib (12 points) from Igede Ekiti. She underwent Ponseti manipulation with long-leg retention casting technique. Casts were changed biweekly for 12 weeks before percutanous tendo Achilles tenotomy was done. Early recurrence occurred at five months after her last cast application. She had two further consecutives ta-localcaneal joint manipulations and Ponseti casts applied to correct the varus and equinus. Open tendo-Achilles lengthening was performed. At the last follow-up clinic visit at twenty months post retention cast, she had satisfactory outcome of her affected foot, Dimeglio-Bensahel 5 points. There was no significant residual abnormal appearance of the foot and full functionality. The natural progress is shown in Figure 1.
A total of 161 major orthopaedic surgeries were performed during the study period of which major clubfoot surgeries were 10.6%. Table 2 shows the various surgical patterns for clubfoot patients. Significant clubfoot surgeries were indicated in 17 patients (34.0%) in the NPCG group. These include extensive soft tissue surgery/posterior capsulotomy for 10 patients (58.8%), tibialis anterior transfers for 3 patients (17.6%), and two patients (11.8%) requiring a McEvans operation and triple arthrodesis respectively. Five of the 17 patients (29.4%) who had extensive soft tissue/bony surgery subsequently required at least one repeat surgery related to an unsatisfactory outcome. Fifty-two patients of the Ponseti group were corrected without tendo-Achilles tenotomy (94.5% vs. 34%, p<0.000). Three (5.5%) of the Ponseti patients had four minor surgeries, tendo-Achilles tenotomies (3 percutanous, 1 open). There was no indication for major soft tissue/bony surgery among all the clubfeet (100%) treated with Ponseti method.
Table 3 shows NPCG patients who required more than six casts as compared to the Ponseti group (70% vs. 23.6%, p<0.000). The mean duration of time to achieve satisfactory clubfoot correction was 4.3-21.0 +/-3.5 weeks among the NPCG and 2.3-13.7+/-1.7 weeks for the Ponseti group (p<0.000). The number of casts applied was not related to patient age (p>0.159). There was no indication for post-correction physiotherapy within the Ponseti group of patients. Twenty-eight (56.0%) of the NPCG patients received passive physiotherapy and the duration of treatment was related to the age of the patient at presentation (p<0.000).
Locally fabricated abduction foot braces were made available for the Ponseti patients. The duration of use and timing varied with each patient's age. There was an initial problem getting an appropriate local shoemaker to produce functional foot braces with consistency in quality. The patient's compliance with the abduction foot braces was generally good.
The Ponseti-treated group, when compared to the NPCG patients, had fewer treatment complications (42% vs. 3.6%, p<0.001), lower recurrence rates (p<0.000) and more satisfactory early full correction outcomes (100.0 % vs. 58%, p<0.000). The mean cost of care was lower for the Ponseti-treated group (p<0.000). A total of $419,900 Naira (US $3683.33) were spent on 17 extensive surgeries in the NPCG group of patients. The cost of treatment was high for the NPCG group as compared to the group using the Ponseti method when the cost of casts greater than six served as an outcome indicator (35 vs. 13, p<0.000).
The Ponseti method of clubfoot correction is based on abundant knowledge of the pathological anatomy and pathogenesis of clubfoot deformity.10 This has contributed positively to the use of the method for patients of all ages, with satisfactory outcomes compared to the use of extensive soft tissue surgery. It is generally agreed that the initial treatment of clubfoot should be nonsurgical and start as soon as possible after birth,14,15 although a large number of pediatric orthopaedists think that success using the Ponseti method depends on whether casting begins within hours of birth.16 Our results suggest that even patients presenting late with clubfeet can be treated successfully with the Ponseti nonoperative technique which is also supported by Lourenco and Morcuende in an earlier report.11
NPCG treatment complications could be related to a poor understanding of the clubfoot with the forces causing the deformity remaining unaltered after manipulation and extensive clubfoot surgery. Most clubfeet in the PCG were successfully corrected without surgery within a short time.
Complex clubfoot deformity of a syndromic type, severe recurrence post extensive clubfoot surgery, and neglected clubfoot all partially relapsed status post Ponseti technique. These patients presented late (beyond six weeks after birth). It has been recognized that relapses occur in severe clubfeet whether these were treated surgically or nonsurgically.17 The Ponseti technique is flexible in that it provides an opportunity to recast patients who lose their corrections. The relapsing cases within the PCG patients were related to a delay in procurement and use of fabricated abduction foot braces. However, relapses were not related to the patient's age at presentation or to the number of casts required for correction.18 The PCG relapse rate was comparable (7%) to that reported by Ponseti18 in noncompliant patients with the straight-laced shoe and abduction bar protocol. Our results and those of Ponseti suggests that the importance of maintaining correction with the foot abduction bar is paramount to successful treatment.19 There was no virgin clubfoot patient treated with the Ponseti method who relapsed. All the relapsed clubfeet patients were successfully treated with further manipulations and recastings for two to six weeks with or without tendo-Achilles tenotomy/lengthening and foot abduction bar regimens.
In the NPCG, 34.0% ended in extensive soft tissue release and bony surgery despite early serial casting similar to Lloyd-Roberts20 report. The primary disadvantages of intermediate and major clubfoot surgery are high complication rates and the difficulty of treatment when this occurs. A 48.0% recurrence associated with NPCG patients agrees with other reports in the 13-50% range.5,21 Other surgical complications include infection, noncosmetic scar formation, skin flap necrosis and wound dehiscence. The high cost of clubfoot care in NPCG was in contrast to the lower cost of the Ponseti method treatment. The major clubfoot surgical care cost was eliminated with the use of Ponseti's methods. There was a significant reduction in the number of retention castings required for complete deformity correction in the Ponseti patients compared to the NPCG patients.
The frequency of indication for major clubfoot surgery which was 100.0% has been reduced to minor operations, similar to that reported by Morcuende et al. from Iowa, USA.12 Our findings are supported further by Ippolito et al.,22 where they concluded after thirty years that extensive surgery is not the right approach to the management of congenital clubfoot, but proper manipulation techniques initiated by Ponseti are. In addition, open surgery weakened ankle plantar flexion and prevented some patients from being able to walk on their toes.22 The clinical correction achieved by using the Ponseti technique has produced a functional, plantigrade foot without requiring posteromedial release in the fifty-five (100%) clubfoot patients managed. Some of the patients who were followed after three years sustained their correction.
Intermediate/major surgery was indicated in 34.0% of NPCG. 29.4% of these patients subsequently required at least a repeat surgery related to unsatisfactory outcome. This was similar to unpublished data from Dr. 0 Onabowale23 on 555 clubfoot patients at the National Orthopaedic Hospital, Igbobi, Lagos, Nigeria. He found that 146 patients (26.3%) had surgical treatment and 19.2% ended unsatisfactorily. Dobbs et al.24 also demonstrated significantly fewer excellent or good outcomes in their surgically treated group.25,26 The oldest clubfoot patient treated with the Ponseti method at age 18 years is a first, as reported in this study. Our results show that a strict Ponseti technique protocol can salvage or treat clubfoot even after several months or years of unsuccessful traditional casting or neglect, without extensive soft tissue surgery.
Ponseti clubfoot management techniques have reduced the need for extensive soft tissue release and major clubfoot surgery, and has changed clubfoot operation patterns in Nigeria.