NCT04279925

A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management

Terminated NA Results posted Last updated 26 April 2022

What this trial tests

NA trial testing ORIF (Open reduction internal fixation): locally-made miniplate and screw in Maxillofacial Injuries in 9 participants. Terminated before completion.

Timeline

11 March 2020

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	Indonesia University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	9
Start date	11 March 2020
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	1 location across Indonesia

Drugs / interventions tested

• ORIF (Open reduction internal fixation): locally-made miniplate and screw
• ORIF: Imported miniplate and screw

Conditions studied

• Maxillofacial Injuries — all drugs for Maxillofacial Injuries →
• Maxillofacial Prosthesis Implantation — all drugs for Maxillofacial Prosthesis Implantation →
• Fracture Fixation, Internal — all drugs for Fracture Fixation, Internal →

Sponsor

Indonesia University

Who can join

18 and older, any sex, with Maxillofacial Injuries or Maxillofacial Prosthesis Implantation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Bone Density Primary · 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.

Group	Value	95% CI
Locally-made Miniplate and Screw	111.3080	-90.2572 – 592.6672
Imported Miniplate and Screw	251.2050	-115.758 – 338.3736

Screw Loosening (Yes/No) Secondary · 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.

Group	Value	95% CI
Locally-made Miniplate and Screw	0
Imported Miniplate and Screw	0

Tissue Reaction (Yes/No) Secondary · 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.

Group	Value	95% CI
Locally-made Miniplate and Screw	0
Imported Miniplate and Screw	0

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.