Clinical Trials of newly designed AORI Foot Abduction Brace and its comparison with Dennis Brown Splint Zeshan Zahid 1 Rehan Ali Malik2 1
Orthotist Prosthetist, UAE, 2Orthotist Prosthetist, UAE Zeshan_zeshan75@yahoo.com
INTRODUCTION OR PURPOSE Clubfoot is the most common congenital deformity in babies. More than 100,000 babies are born worldwide each year with congenital clubfoot. The main goal of treatment is to achieve a functional, pain-free, plantigrade foot with good mobility and without surgery. The management/treatment of idiopathic congenital clubfoot is serial gentle manipulations to stretch the contractures of the ankle, after serial casting, splinting, or strapping is started to maintain the correction. Now a days Ponseti technique is common practicing technique followed by the effective orthotic intervention (bracing schedule). The Ponseti method is safe and effective treatment for congenital idiopathic clubfoot, and radically decreases the need for extensive corrective surgery. METHODS Non randomized interventional study. Study subjects were selected by convenient sampling method. It was Therapeutic intervention/ experimental study without strict protocol with sample size of 110 patients divided in study and control group. 30 patients using AORI FAB were included in study group whereas data of 80 patients using DB Splint with information on variables under study was included in control group. Study was performed in Rawalpindi division at Benazir Bhutto Hospital Rawalpindi. It was 4 years study from 1st April 2011 to 30 March 2015. RESULTS Deformity relapsed in 15% of patients in control group but it was not relapsed in study group where P Value was <.05. Skin damage occurred in almost 50% of patients in control group but it was about 21% in study group with P-value = <.05. Residual adduction was reported in >50% of patients of patients in control group and it was about 0% in study group with P-value = <.001 which is highly significant. Fabrication Cost of AORI Foot Abduction Brace was >50% less than the DB Splint. CONCLUSION AORI foot abduction brace is light in weight and having dynamic effects for Dorsi-flexion while D.B splint is relatively heavy and was poor to maintain Dorsi-flexion at ankle joint, which ultimately leads to the relapse of the abduction and then equinus. There is chance of skin damage in AORI FAB if not properly fitted especially on heel part. Superficial skin damage (bruise etc) were noticed in most of the patients using DB Splint. In AORI FAB too much tightening of Velcro straps may cause the edema of the distal part of the foot. Our clinical trials of the AORI FAB shows very good results in maintenance of
the corrected C.T.E.V as Marcunde described in Ponseti Management manual that relapse occurs in more than 80% of cases, where relapse occurs only 6% in compliant families and there is more family compliance of AORI FAB at low cost. SIGNIFICANCE The designed involves no leather work and provides fixed dorsiflexion and abduction as per requirement. The material of the brace is recyclable (Polypropylene) and can be fabricated at industrial level and is easy to assemble in few minutes. On the other hand it very be very cost effective and light in weight. Picture is given bellow as figure 1. REFERENCES 1.Pryor GA, Villar RN, Ronen A, Scott PM. Seasonal variation in the incidence of congenital talipes equinovarus. JBJS 1991 73B (4): 632-634 2.Falks S, Luther B. Changing paradigm for the treatment of clubfoot. Orthopaedic Nursing 2005 24(1): 25-30. 3.Ponseti IV. Treatment of congenital clubfoot: Current concepts review. J Bone Joint Surg Am.1992;74:448â&#x20AC;&#x201C;54. Herzenberg JE, Radler C, Bor N. Ponseti versus kite methods of casting for idiopathic clubfoot. J Pediatr Orthop. 2002;22:517â&#x20AC;&#x201C;21. DISCLOSURE Short sampled, non-randomized clinical trials. There is industry related issue involved. ACKNOWLEDGMENTS Thanks to My dear fellow Rehan Ali Malik for his kind support and help in fabrication of the device.
Figure 1. AORI Foot Abduction Brace.
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