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

NCT ID: NCT04279925

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-11
• Study Completion Date: 2020-05-31

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

Conditions

Maxillofacial Injuries; Maxillofacial Prosthesis Implantation; Fracture Fixation, Internal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Locally-made Miniplate and screw

Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Imported Miniplate and screw

Biomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface.

Group Type: ACTIVE_COMPARATOR

ORIF: Imported miniplate and screw

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

dr. Prasetyanugraheni Kreshanti, SpBP-RE (KKF)

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto mangunkusumo National Hospital

Jakarta Pusat, Central, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1085/UN2.F1/ETIK/PPM.0002/2019

Identifier Type: -

Identifier Source: org_study_id