A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management

Not Applicable

Terminated

• Conditions: Fracture Fixation, Internal; Maxillofacial Prosthesis Implantation; Maxillofacial Injuries

• Registration Number: NCT04279925
• Lead Sponsor: Indonesia University

Brief Summary

The study is a blind randomized clinical study on patients with midface maxillofacial fractures coming to Cipto Mangunkusumo Hospital. The subject is the fracture line who met the inclusion criteria and randomly allocated into the study (locally-made miniplate and screw) and control (BIOMET® miniplate and screw) group through a predetermined randomization list. The healing process is follow up using non-contrast head computed tomography immediately after surgery as a baseline, and 3 months post-op. Afterward, a radiologist consultant as a blinded evaluator will evaluate the score of bone density, and screw loosening, while local tissue reaction after fixation evaluates during the patient's visit outpatient clinic. All scores from points of the evaluation group will be collected and going to statistically evaluated using independent t-test or Mann Whitney test depending on the distribution of the data

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-03-11
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Results First Submitted: 2020-09-02
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-23
• Last Update Submitted: 2022-04-23
• Results First Posted: 2022-04-26
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Midface fracture with the indication of surgery
• Midface fracture sustained within 2 weeks

Exclusion Criteria

• Comminuted and defect fracture
• Midface fracture on patients with systemic diseases affecting bone healing.
• Midface fracture in children
• Midface fracture in multiple trauma patients with neurological deterioration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bone Density	3 months	The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images.The Hounsfield unit, also referred to as the CT unit, is then calculated based on a linear transformation of the baseline linear attenuation coefficient of the X-ray beam, where air is usually -1000 HU and air 0 HU. The HU for bones ranges from 148 (cancellous bones) to 3000 (dense bones), -700 to 225 HU for soft tissues, -205 to -72 HU for fat, and -5 to 139 for muscle.

Secondary Outcome Measures

Name	Time	Method
Tissue Reaction (Yes/No)	3 weeks	Clinical signs of local inflammation process, will be recorded by the end of the 3rd week during patient's visit in outpatient clinic. It will be evaluated by consultants of craniomaxillofacial surgery. The outcome will be presented as the number of patients with signs of local inflammation.
Screw Loosening (Yes/No)	3 months	Screw loosening will be recorded, whether it is present or not. It will be evaluated by a radiologist consultant after the subject completed all their Head CT evaluation. The outcome will be presented as the percentage of patients with screw loosening, evaluated from head CT Scan.

Trial Locations

Locations (1)

Cipto mangunkusumo National Hospital; 🇮🇩 Jakarta Pusat, Central, Indonesia