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

NCT04279925 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-04-26

Study results available
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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

Conditions

  • Maxillofacial Injuries
  • Maxillofacial Prosthesis Implantation
  • Fracture Fixation, Internal

Interventions

DEVICE

ORIF (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.

DEVICE

ORIF: 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 & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04279925 on ClinicalTrials.gov