Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.

This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.

Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.

Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022–23; Ethikkommission Nordwest- und Zentralschweiz, 2019–02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019–04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025–18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19–589; Komisja Bioetyczna przy Warmiłsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019–0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.

NCT03991728.

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.

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 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.

NCT03887988.