Oral and maxillofacial surgery Surgery Oral and maxillofacial surgery
Conditions
Interventions
20 patients in each of 3 Units (total 60) will be treated with Rapid IMF™.
20 controls in each Unit (total 60) will be treated with eyelet wires.
Sponsors
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria amended as of 2nd January 2008: 1. Age 18 and over 2. Provision of written informed consent 3. Dentate patients with fractures of the mandible which require ORIF, where post operative Inter-Maxillary Fixation is not considered necessary and temporary intraoperative Inter-Maxillary Fixation could be achieved with either Eyelet wiring or Rapid IMF™ (as judged by the investigator) Inclusion criteria provided at time of registration: 1. Patients undergoing open reduction and internal fixation (ORIF) of mandibular fractures 2. Twenty patients in each unit (60) will be treated with Rapid IMF 3. Twenty controls in each unit (60) will be treated with Eyelet wires
Exclusion criteria
Exclusion criteria: Exclusion criteria added as of 2nd January 2008: 1. Decreased level of consciousness 2. Learning difficulties and history of significant psychiatric or somatic disease, which may interfere with the detection of complications and assessment of functional result, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of perforations/operation specific to the type of IMF | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures added as of 2nd January 2008: 1. Number and types of exposure sustained by the surgeon, the assistant and the scrub nurse and their cause 2. Incidence of unnoticed glove perforations 3. Time and degree of difficulty for IMF application 4. Numbers of surgical complications | — |
Countries
United Kingdom
Outcome results
None listed