What is SECEC Mason type II Radial Head fractures study?
The SECEC Radial Head study is a prospective, observational study of patients diagnosed with Mason type II radial head fractures treated conservatively (immobilization and early rehabilitation) or surgically (non-randomized) with the following inclusion criteria :
- Isolated radial head or neck fractures type II determined by RX and CT scan
- Absence of previous dislocations or associated fractures
Its primary objective is to evaluate conservative and surgical outcomes of these fractures.
Secondary objectives are :
- To identify whether the anatomical location of Mason type II radial head fractures influences medium-term functional outcomes in patients treated conservatively and surgically.
- To analyze demographic, clinical, and anatomical factors that may influence the outcome.
- Depending on the number of patients included for each group, if possible, to elaborate a propensity matching score studio in order to compare surgical to conservative treatment.
The study is initiated by Maria Valencia (Spain), Giovanni Merolla (Italy) and Roger van Riet (Belgium).
Experienced centers that expect to be able to include more than 5-8 cases are warmly invited to contribute their cases and expertise.
Why participate?
- enjoy a dedicated userfriendly online tool to collect your data
- compare your results anonymously with other centers
- get a chance to publish your national findings (with SECEC approval)
How to participate?
Step 1 - registration (for SECEC members only) : fill-in your details in the online form to register your interest to contribute. Maria Valencia will be contacting you shortly to share detailed information about how to get involved in the project.
Step 2 - Ethics committee's approval : submit a study application to your local (and, if required, national) ethics committee. All necessary documents are prepared and made available for eligible centres upon request :
- Steps for conducting a multicenter clinical study
- Multicentric Research Study description
- Case Report form
- Informed Consent Form (ICF)
- Data Sharing Agreement
Additional 1 : List of national authorities
Please note that the documentation provided by SECEC serves as a general template designed to comply with European GDPR regulations. Each surgeon is responsible for completing and adapting these documents to meet the specific requirements of their local ethics committee.
Step 3 - data entry and analysis : once the Ethics Committee has approved the participation to the study, SECEC provides a database access via EasyMedStat (for SECEC members only), with support from the SECEC. Please note that EasyMedStat access will be withdrawn after one year of inactivity.
Do not hesitate to contact the SECEC Office for any questions you might have.