Health Condition 1: Q189- Congenital malformation of face and neck, unspecified
Conditions
Interventions
Intervention1: Craniomaxillocofacial (CMF) plates and screws for fixation of facial bone deformity and fractures: CMF plates and screws will be used for fixation of facial bones.
Control Intervention1
Sponsors
Auxein Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female, aged 18 - 75 years. 2. Patients presenting emergency/OPD requiring fixation of CMF fracture.
Exclusion criteria
Exclusion criteria: 1. Subjects with a disease entity or condition that could hinder bone healing and create unacceptable risk of fixation failure or complications such as known active cancer, neuromuscular disorder. 2. Subjects with metabolic bone disease. 3. Subject with inadequate tissue coverage of the operative site. 4. Subjects with substance abuse/alcoholics. 5. Subjects who are incarcerated or have pending incarceration. 6. Female participant who is pregnant or planning pregnancy during the study. 7. Morbid obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Bone healing and union 2 Improvement in QOLTimepoint: 6 week 3 month 6 month and 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Recording of AEs SAEsTimepoint: 6 week 3 month 6 month and 12 month | — |
Countries
India
Contacts
Public ContactDr Mohd Aslam
Auxein Medical Pvt Ltd
Outcome results
None listed