Fracture Fixation, Internal, Maxillofacial Injuries, Maxillofacial Prosthesis Implantation
Conditions
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
Interventions
DEVICEORIF (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.
DEVICEORIF: 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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
a radiologist consultant as a blinded independent evaluator will assess the bone density score in each subject.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Indonesia
Participant flow
Pre-assignment details
* participants signed the informed consent form and declare that they want to be enrolled as subjects and obey all the instructions given postoperatively * They were showered with chlorhexidine 4% soap one day before surgery
Participants by arm
| Arm | Count |
|---|---|
| Locally-made Miniplate and Screw Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. | 4 |
| Imported Miniplate and Screw Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Locally-made Miniplate and Screw | Imported Miniplate and Screw | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Bone density | 111.3080 Hounsfield Unit (HU) STANDARD_DEVIATION 182.872 | 251.2050 Hounsfield Unit (HU) STANDARD_DEVIATION 214.591 | 181.2565 Hounsfield Unit (HU) STANDARD_DEVIATION 198.7315 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Indonesia | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Locally-made Miniplate and Screw | Bone Density | 111.3080 Hounsfield Unit (HU) |
| Imported Miniplate and Screw | Bone Density | 251.2050 Hounsfield Unit (HU) |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Locally-made Miniplate and Screw | Screw Loosening (Yes/No) | 0 Participants |
| Imported Miniplate and Screw | Screw Loosening (Yes/No) | 0 Participants |
Secondary
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.
Time frame: 3 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Locally-made Miniplate and Screw | Tissue Reaction (Yes/No) | 0 Participants |
| Imported Miniplate and Screw | Tissue Reaction (Yes/No) | 0 Participants |