A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
Primary Purpose
Maxillofacial Injuries, Maxillofacial Prosthesis Implantation, Fracture Fixation, Internal
Status
Terminated
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
ORIF (Open reduction internal fixation): locally-made miniplate and screw
ORIF: Imported miniplate and screw
Sponsored by
About this trial
This is an interventional treatment trial for Maxillofacial Injuries
Eligibility Criteria
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
Sites / Locations
- Cipto mangunkusumo National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Locally-made Miniplate and screw
Imported Miniplate and screw
Arm Description
Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.
Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04279925
Brief Title
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
Official Title
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Aerosol risk of COVID-19 spread resulting a slow subject recruitment
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
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
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillofacial Injuries, Maxillofacial Prosthesis Implantation, Fracture Fixation, Internal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
a radiologist consultant as a blinded independent evaluator will assess the bone density score in each subject.
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Locally-made Miniplate and screw
Arm Type
Experimental
Arm Description
Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.
Arm Title
Imported Miniplate and screw
Arm Type
Active Comparator
Arm Description
Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.
Intervention Type
Device
Intervention Name(s)
ORIF (Open reduction internal fixation): locally-made miniplate and screw
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ORIF: Imported miniplate and screw
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone Density
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Screw Loosening (Yes/No)
Description
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.
Time Frame
3 months
Title
Tissue Reaction (Yes/No)
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cipto mangunkusumo National Hospital
City
Jakarta Pusat
State/Province
Central
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
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