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Aerosol risk of COVID-19 spread resulting a slow subject recruitment
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locally-made Miniplate and screw | Experimental | Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. |
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| Imported Miniplate and screw | Active Comparator | Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORIF (Open reduction internal fixation): locally-made miniplate and screw | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto mangunkusumo National Hospital | Jakarta Pusat | Central | 10430 | Indonesia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Locally-made Miniplate and Screw | Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia |
| FG001 | Imported Miniplate and Screw | Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2019 |
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a radiologist consultant as a blinded independent evaluator will assess the bone density score in each subject.
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| ORIF: Imported miniplate and screw | Device | 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. |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Locally-made Miniplate and Screw | Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. |
| BG001 | Imported Miniplate and Screw | Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Mean | Standard Deviation | Hounsfield Unit (HU) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Hounsfield Unit (HU) | 3 months |
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| 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. | Posted | Count of Participants | Participants | 3 months |
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| 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. | Posted | Count of Participants | Participants | No | 3 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Locally-made Miniplate and Screw | Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | Imported Miniplate and Screw | Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. | 0 | 5 | 0 | 5 | 0 | 5 |
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Due to the COVID-19 pandemic, it is difficult to reach the number of samples as planned, the clinical study was underpowered. The clinical study will be extended (currently submitting amendment of ethical clearance), to reach more power in the study
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prasetyanugraheni Kreshanti, MD | Plastic Surgery Division of Surgery Department of Cipto Mangunkusumo Hospital Jakarta / Faculty of Medicine Universitas Indonesia | 08158732424 | pras_md@yahoo.com |
| Oct 20, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2022 | Apr 23, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| ID | Term |
|---|---|
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| Between 18 and 65 years |
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| >=65 years |
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