Trial Outcomes & Findings for A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management (NCT NCT04279925)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

3 months

Results posted on

2022-04-26

Participant Flow

* 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

Participant milestones

Participant milestones
Measure	Locally-made Miniplate and Screw Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia	Imported Miniplate and Screw Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.
Overall Study STARTED	4	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Locally-made Miniplate and Screw n=4 Participants Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.	Imported Miniplate and Screw n=5 Participants Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	5 Participants n=5 Participants	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Sex: Female, Male Female	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=9 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	5 Participants n=5 Participants	9 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Indonesia	4 participants n=4 Participants	5 participants n=5 Participants	9 participants n=9 Participants
Bone density	111.3080 Hounsfield Unit (HU) STANDARD_DEVIATION 182.8720 • n=4 Participants	251.2050 Hounsfield Unit (HU) STANDARD_DEVIATION 214.5910 • n=5 Participants	181.2565 Hounsfield Unit (HU) STANDARD_DEVIATION 198.7315 • n=9 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Locally-made Miniplate and Screw n=4 Participants 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.	Imported Miniplate and Screw n=5 Participants 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.
Bone Density	111.3080 Hounsfield Unit (HU) Interval -90.2572 to 592.6672	251.2050 Hounsfield Unit (HU) Interval -115.758 to 338.3736

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Locally-made Miniplate and Screw n=4 Participants 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.	Imported Miniplate and Screw n=5 Participants 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.
Screw Loosening (Yes/No)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Locally-made Miniplate and Screw n=4 Participants 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.	Imported Miniplate and Screw n=5 Participants 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.
Tissue Reaction (Yes/No)	0 Participants	0 Participants

Adverse Events

Locally-made Miniplate and Screw

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Imported Miniplate and Screw

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prasetyanugraheni Kreshanti, MD

Plastic Surgery Division of Surgery Department of Cipto Mangunkusumo Hospital Jakarta / Faculty of Medicine Universitas Indonesia

Phone: 08158732424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place