FAQs

CoULD is a multicenter registry for Congenital Upper Limb Differences. Congenital differences of the upper limb refer to hands or arms that do not form the usual way before birth. Examples include syndactyly (webbed fingers), polydactyly (having more than five fingers on a hand), radial dysplasia (a condition where one of the bones of the forearm is short or absent), or radioulnar synostosis (an abnormal bone connection between the bones of the forearm). While some of these differences are passed down in families, the majority do not have a clear cause.

Because they are relatively uncommon, and because there is variety in the types of congenital differences that occur, our understanding of congenital differences will only improve by following and studying large numbers of patients from multiple hospitals around the country. The CoULD Registry has been created to achieve this goal.

CoULD was started in St. Louis and Boston in 2014 to address the lack of scientific information on birth anomalies of the upper extremity. Charles Goldfarb and Summer Roberts in St. Louis and Donald Bae and Fernanda Canizares in Boston worked to build the concept of the CoULD Registry over several years. Once we launched the project, we worked to obtain approval from our institutions, develop the protocols, and encourage other institutions across North America to join our effort.  We are excited about our progress!

Our children and patients are often our greatest teachers. Congenital differences are rare and come in many forms. This research will improve our understanding of how children with congenital differences function and how they improve after surgical or non-surgical treatment. With this knowledge, we hope to continue to improve the care we provide.

CoULD is a multi-center registry, which means that multiple doctors from multiple hospitals across the country are involved. CoULD is led by Dr. Donald S. Bae at Boston Children’s Hospital and Dr. Charles A. Goldfarb at Washington University / Shriners Hospital St. Louis. Currently, the following institutions have CoULD doctors working on this important project:

• Boston Children’s Hospital in Boston, MA
• St. Louis Children’s Hospital in St. Louis, MO
• Shriners Children’s St. Louis in St. Louis, MO
• Seattle Children’s Hospital in Seattle, WA
• Nationwide Children’s Hospital in Columbus, OH
• Gillette Children’s Hospital in Minneapolis, MN
• Shriners Children’s Northern California in Sacramento, CA
• Primary Children’s Hospital in Salt Lake City, UT
• Shriners Children’s Salt Lake in Salt Lake City, UT
• Children’s Hospital of Philadelphia in Philadelphia, PA
• The Hand & Upper Extremity Center of Georgia in Atlanta, GA
• Children’s Hospital Los Angeles in Los Angeles, CA

If you/your child agree to take part in this study, your visit might be extended by about 10 to 30 minutes. After you complete the first visit, we will follow your medical record and collect follow-up information at annual appointments for a period of 5 years, and then every three years until you/your child turns 18 years of age (or until you/your child wants to stop participating).

There are no direct benefits from your/your child’s participation. The primary benefit of this study is increased understanding of the long-term benefits of treatment for congenital hand and upper limb differences, which may assist in the treatment of future patients.

Our research staff is highly trained to protect your privacy and avoid any breaches in confidentiality. All the information collected will be stored in a secure database called REDCap, so that only authorized study personnel have access. All hard-copy information will be stored in locked filing cabinets in the orthopedic research offices and typed into electronic, password-protected documents. If we write a report or article about this study or share the study dataset with other CoULD centers, we will do so in such a way that you/your child cannot be directly identified. If you have authorized sharing contact information for future studies in the consent form, you might be contacted to participate in research studies other than CoULD.

During the scheduled clinical visit, you/your child will be asked to be part of the CoULD Registry. If you choose to participate, the number of hospital visits will be the same, and there won’t be additional treatments. The only differences will be: 

1. We will ask you to answer some questions related to why you’re visiting the hand clinic. 
2. You and your child will be asked for permission to take a photograph of the arm or hand to show how the arm or hand changes after treatment and over time.   
3. We also will ask you to fill out questionnaires at the first clinic visit and at follow-up visits.

Additionally, if it is not possible to complete the questionnaires during your clinic visit, surveys can be sent via email. By agreeing to participate in this study, you are also agreeing to allow research staff to review your/your child’s past medical records for study purposes.

Participation in this registry is completely voluntary. You/your child may withdraw from this study at any time. You/your child will be given an opportunity to ask questions of the research coordinator and doctors at any point during the study. Declining to participate in this registry will not alter the treatment your child will receive.