To evaluate the safety and performance of facial bone plates and time taken in bone union.
Phase 4
- Conditions
- Health Condition 1: Q189- Congenital malformation of face and neck, unspecified
- Registration Number
- CTRI/2024/07/070241
- Lead Sponsor
- Auxein Medical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Male or Female, aged 18 - 75 years.
2. Patients presenting emergency/OPD requiring fixation of CMF fracture.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method