TY - JOUR
T1 - Surgical versus non-surgical management of orbital fractures
T2 - study protocol for evidence generation of a prospective multicentre observational cohort registry
AU - Wolvius, Eppo B.
AU - Strabbing, Elske M.
AU - The OFx Registry Study Group
AU - Thieringer, Florian
AU - Jelovac, Drago B.
AU - Al-Khalil, Moustafa
AU - Rughubar, Vivesh
AU - Korn, Philippe
AU - Emodi, Omri
AU - Calle, Alvaro Rivero
AU - Epifanov, Sergey
AU - Smolka, Wenko
AU - Piombino, Pasquale
AU - Strong, E. Bradley
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.
PY - 2025/7/30
Y1 - 2025/7/30
N2 - Introduction:There remains little consensus or guidelines for the clinical management of traumatic orbital fractures (OFx). The OFx Registry aims to increase real-world clinical evidence for the treatment of OFx via prospective, multicentre, international data collection. The primary objectives of this observational cohort study are (1) to document current treatment practices for and (2) to assess the outcomes of surgical and non-surgical treatment of orbital floor and/or medial wall fractures. Methods and analysis: Approximately 300 adult patients presenting with a displaced OFx in the orbital floor and/or medial wall will be enrolled prospectively over a recruitment period of ∼36 months. All eligible patients treated either surgically or non-surgically as per routine standard of care will have follow-up assessments at 6 weeks, 3 months and 6 months post-treatment. Demographic data, injury details, treatment details and outcome measures will be documented in a cloud-based database. Outcome measures include clinical outcomes (eg, diplopia, extraocular motility, and condition of the eyelid, globe and soft tissues), radiological outcomes from collected images, patient-reported outcomes (eg, Diplopia Questionnaire and the newly developed AO Craniomaxillofacial (CMF) Injury Symptom Battery) and complications. A statistical analysis plan will be prepared before final analysis summarising the descriptive statistics to be used for data assessment. Appropriate research questions and statistical tests may be applied additionally, depending on the availability and quality of data collected. Ethics and dissemination: Ethics approval was obtained before patients were enrolled at each participating site. Patient enrolment followed an informed consent process approved by the responsible ethics committee. Peer-reviewed publications are planned to disseminate the study results.
AB - Introduction:There remains little consensus or guidelines for the clinical management of traumatic orbital fractures (OFx). The OFx Registry aims to increase real-world clinical evidence for the treatment of OFx via prospective, multicentre, international data collection. The primary objectives of this observational cohort study are (1) to document current treatment practices for and (2) to assess the outcomes of surgical and non-surgical treatment of orbital floor and/or medial wall fractures. Methods and analysis: Approximately 300 adult patients presenting with a displaced OFx in the orbital floor and/or medial wall will be enrolled prospectively over a recruitment period of ∼36 months. All eligible patients treated either surgically or non-surgically as per routine standard of care will have follow-up assessments at 6 weeks, 3 months and 6 months post-treatment. Demographic data, injury details, treatment details and outcome measures will be documented in a cloud-based database. Outcome measures include clinical outcomes (eg, diplopia, extraocular motility, and condition of the eyelid, globe and soft tissues), radiological outcomes from collected images, patient-reported outcomes (eg, Diplopia Questionnaire and the newly developed AO Craniomaxillofacial (CMF) Injury Symptom Battery) and complications. A statistical analysis plan will be prepared before final analysis summarising the descriptive statistics to be used for data assessment. Appropriate research questions and statistical tests may be applied additionally, depending on the availability and quality of data collected. Ethics and dissemination: Ethics approval was obtained before patients were enrolled at each participating site. Patient enrolment followed an informed consent process approved by the responsible ethics committee. Peer-reviewed publications are planned to disseminate the study results.
UR - https://www.scopus.com/pages/publications/105012385994
U2 - 10.1136/bmjopen-2025-100508
DO - 10.1136/bmjopen-2025-100508
M3 - Article
C2 - 40738644
AN - SCOPUS:105012385994
SN - 2044-6055
VL - 15
JO - BMJ open
JF - BMJ open
IS - 7
M1 - e100508
ER -