Zygomatic Fractures
Conditions
Brief summary
The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.
Detailed description
The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used: Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.
Interventions
PROCEDUREsubtarsal approach
surgical approach
PROCEDUREconventional transconjunctival approach
surgical approach
PROCEDUREtransconjunctival approach with Y- modification
surgical approach
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients with ZMC fractures requiring open reduction and internal fixation. * Adult patients aged between 20 and 50 years with no gender predilection.
Exclusion criteria
* An existing laceration in the inferior and lateral periorbital site. * Infection at the fracture line. * Comminuted fracture with bone loss. * Acute and chronic conjunctival diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| accessibility to the fracture site | intraoperative | Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No |
| esthetic appearance and scarring | 6 weeks postoperative | Postoperative scarring was recorded as noticeable or unnoticeable |
| radiographic verification of adequacy of fracture reduction | immediate postoperative | computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration for exposure of the fracture site | intraoperative | The duration from performing the incision till the field exposure calculated in minutes |
| postoperative pain | at 24 hours and 1 week | Pain was evaluated at 24 hours and at 1 week according to a 10-point Visual Analogue Scale (VAS), (0-1=none,2-4=mild,5-7=moderate,8-10=severe). |
| sensory nerve function | 3 months postoperative | Subjective assessment of the infraorbital nerve sensation by patient questioning about any alteration in sensation at 3 months postoperatively. Objective assessment by dental probe pressure to assess sensory changes along the distribution of the infraorbital nerve with contralateral side comparison |
Countries
Egypt
Outcome results
None listed