1.1 Introduction Clubfoot is the most common musculoskeletal birth defect affecting 1 in 800 children (1.2 per 1000 live births), or approximately 200,000 babies each year globally (80% mainly in developing countries). An estimated 1 million children are currently living with untreated clubfoot. In India, every 10 minutes, a child is born with clubfoot i.e. over 32,000 children are born with this deformity every year. The Ponseti method is now recognized as the accepted standard for the treatment of clubfoot. The Ponseti method is ideally suited for the developing world in that it is inexpensive, non-surgical and the casting component can be completed by trained medical and paramedical personnel. Clubfoot causes the feet of the affected individual to point downward and inward. Left untreated, clubfoot causes a permanent physical disability, preventing the individual from walking normally and limiting his or her mobility. Decreased ambulation can lead to the inability to perform daily tasks, such as going to school, leading to increased dependency and a negative economic impact on the family. Furthermore, deformity caused by neglected clubfoot can lead to limited social integration and stigma for both the individual and the family. The gold standard of clubfoot treatment is the Ponseti method, which consists of 6-8 weeks of serial castings followed by a percutaneous Achilles tenotomy in the majority of cases. The casting is followed by the use of a foot abduction brace (FAB) for approximately 4 – 5 years. The goal of the treatment is to correct the deformity so that the patient has a functional, painless, plantigrade foot with full mobility and without the need for orthotics. Serial manipulations & castings over 6 – 8 weeks corrects the clubfoot deformity, while the use of the FAB after casting prevents the deformity from recurring and is required for successful treatment. Noncompliance of FAB use increases the risk of relapse 17-fold. The Ponseti method was adopted as the standard of care for the treatment of clubfoot at our institution since 2002. In 2011, we developed a program-based approach to clubfoot treatment. The goal of this program-based approach was to provide standardized treatment of clubfoot by training orthopaedic surgeons in the Ponseti method, providing foot abduction braces, spreading awareness about clubfoot in the community, ensuring meticulous record-keeping, encouraging bracing compliance by parent counselling, and maintaining a dedicated telephonic helpline for parent support. The aim of our study is to now develop a prospective registry of all patients treated at our clinic and to analyze the long-term results of treatment using the Ponseti method.
STUDY OBJECTIVES The primary objective of this study is to develop a general prospective registry that includes all types of clubfoot patients with follow up to skeletal maturity.
The purpose of the study is to determine the outcomes of the Ponseti method when implemented in a consistent manner and as a part of a suite of programmatic activities designed to achieve optimal outcomes for children born with clubfoot.
Study Design This prospective observational nature of the general registry which aims to target the children who present to our clinic with any form clubfoot for treatment by the Ponseti method. This study will provide new and relevant data on the quality of clubfoot treatment using the Ponseti method. This prospective study will analyze: demographic data (sex ratio, age at presentation, Pirani score at presentation), treatment process data (average number of casts per patient, rate of Achilles tenotomies, rate at which patients drop out of treatment during the casting and bracing phases), and clinical outcome data (Pirani scores before bracing, common complications, and referrals to surgery).
Cases getting registered in our dedicated Clubfoot Clinic from 1st January 2021 onwards will be included in this prospective registry.
Patient Enrollment Patients who meet the registry inclusion criteria will be offered enrollment in the study after obtaining the consent from the parents. Parents will be informed of the nature of the child’s condition (as a part of their routine visit) and the treatment of the condition by the Ponseti method, need for Achilles tenotomy at the end of casting phase, and importance of regular follow up will be explained. The risks, benefits, advantages of this method will be detailed with the family, as a part of their routine initial visit with their doctor. Parental decision to participate only provides permission for the child’s anonymized data to be entered into the study database (International Clubfoot Registry) for subsequent analysis and will not alter the actual management of the child’s condition. All the patients enrolled in the registry will be analyzed at each visit before the casting by Ponseti method. The Pirani score will be documented at each visit in a patient-specific folder. At each visit, clinical photographs will be obtained pre-casting with a unique ID number assigned for each child. After completion of casting, foot abduction brace will be provided. During the bracing phase, the child will be followed up at monthly intervals for the initial 6 months, then once in 3 months upto 2 years of age, and after that once in 6 months till skeletal maturity.
Data Collection At the initial visit, baseline patient demographic information will be collected, including date of birth, date of presentation, diagnosis (type of clubfoot and laterality), similar complaints in other family members, whether diagnosed antenatally or postnatally, clinical photographs and Pirani score at presentation. Clinical photographs will only include the feet of the child and the unique ID number assigned to the child. The identity of the patient will not be revealed in the clinical photographs. Data elements to be collected are given in Patient intake form I. During the follow up visits, following data will be collected – date of visit, purpose or type of visit, Pirani scores at visit, indication of relapse by evaluator, transfer of patient for surgery or other treatment, as applicable. Data elements to be collected at follow up visits are given in Patient intake form IB, Pirani score sheet, Patient visit detail form IA.
Data Management The data will be entered into the International Clubfoot Registry (ICR) database by the research coordinator, data entry operator or the principal investigator at the study site and terms and conditions given in Annexure 8. After eliminating the patient identifiable information, each patient will be assigned a unique ID number with a specific centre ID. The list of codes and patient information will be maintained in a separate diary, this list remains confidential to the site. The coded data will be entered into an institution-specific portal on a password-protected online database (International Clubfoot Registry). The ICR is a resource to advance the treatment of clubfoot and is available free of charge to doctors using the Ponseti Method around the world. This password-protected database is managed by the University of Iowa’s Center for Bioinformatics and Computational Biology in collaboration with the Ponseti International Association, USA. The ICR complies with US standards for Privacy and Security of Electronic Health Information (Annexure 9). Technical support is provided by the University of Iowa at clubfoot@eng.uiowa.edu.
The International Clubfoot Registry will house the general prospective registry of all enrolled patients. Each participating center will have access only to their respective patient information or code lists. |