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

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

Study Overview

• Status: Terminated
• Conditions: Maxillofacial Injuries; Fracture Fixation, Internal; Maxillofacial Prosthesis Implantation
• Intervention / Treatment: Device: ORIF (Open reduction internal fixation): locally-made miniplate and screw; Device: ORIF: Imported miniplate and screw

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Central
    • Jakarta Pusat, Central, Indonesia, 10430
      • Cipto Mangunkusumo National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Locally-made Miniplate and screw; Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.	Device: ORIF (Open reduction internal fixation): locally-made miniplate and screw; Fracture lines in this group underwent open reduction internal fixation (ORIF) procedure which consists of realignment of the bone achieved from surgical mean and stabilization of the bone fragments by using locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. The plate used in the study is a straight plate with 4 and 5 holes with the dimension of 17mm long, 4 mm wide and 0.56 mm thick.
ACTIVE_COMPARATOR: Imported Miniplate and screw; Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.	Device: ORIF: Imported miniplate and screw; Fracture lines in this group underwent open reduction internal fixation (ORIF) procedure which consists of realignment of the bone achieved from surgical mean and stabilization of the bone fragments by using Biomet® miniplate 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. The particular plate used in the study is a straight plate with 4 holes, 17mm length and 0.6mm thick, coded 01-7047 in the catalog. Biomet® screw 1.5 utilized in this study is also produced by Biomet, included in the Lorenz® Plating System Midface. The dimension of the screw is 4mm length, 1.5 mm diameter, and coded 91-6104 1.5 mm X-Drive Self drilling screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Density	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screw Loosening (Yes/No)	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.	3 months
Tissue Reaction (Yes/No)	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.	3 weeks

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2020
• Primary Completion (ACTUAL): May 31, 2020
• Study Completion (ACTUAL): May 31, 2020

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (ACTUAL): February 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Fractures, Bone; Maxillofacial Injuries
• Other Study ID Numbers: 1085/UN2.F1/ETIK/PPM.0002/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No