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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
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillofacial Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

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

First Posted
February 10, 2020
Last Updated
April 23, 2022
Sponsor
Indonesia University
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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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