What is SECEC Mason type II Radial Head Fractures Study?
The SECEC Mason type II RHF 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 ulnar fractures other than coronoid type I
Its primary objective is to evaluate whether the anatomical location of Mason type II radial head fractures influences medium-term functional outcomes in patients treated conservatively and surgically.
Its secondary objective are :
- To identify the frequency and type of injuries associated with this type of fracture and their relationship to functional outcomes.
- To analyze demographic, clinical, and anatomical factors that may influence the outcome.
- To elaborate a propensity matching score studio in order to compare surgical to conservative treatment.
The study is initiated by Lars Adolfsson (Sweeden), Hanna Björsson (Sweden), Pierre Mansat (France), Maria Valencia (Spain) and Roger van Riet (Belgium).
Experienced centres with at least 10 confirmed cases and robust data 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?
Experienced centres with at least 10 confirmed cases and robust data are warmly invited to contribute their cases and expertise.
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 available below :
- Steps for conducting a multicenter clinical study
- Multicentric Research Study description
- Case Report form - PJI Study (CRF)
- 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.