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

University of Indonesia (UI)

Status: Terminated

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

Treatments: Device: ORIF: Imported miniplate and screw; Device: ORIF (Open reduction internal fixation): locally-made miniplate and screw

Study type: Interventional

Funder types: Other

Identifiers

NCT04279925

1085/UN2.F1/ETIK/PPM.0002/2019

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Locally-made Miniplate and screw

Experimental group

Description:

Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.

Treatment:

Device: ORIF (Open reduction internal fixation): locally-made miniplate and screw

Imported Miniplate and screw

Active Comparator group

Description:

Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.

Treatment:

Device: ORIF: Imported miniplate and screw