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

NCT04279925 | Terminated Results

• 1 other identifier: 1085/UN2.F1/ETIK/PPM.0002/2019
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Screw Loosening (Yes/No)

  3 months

• Tissue Reaction (Yes/No)

  3 weeks

Study Arms (2)

Locally-made Miniplate and screw

EXPERIMENTAL

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

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

Imported Miniplate and screw

ACTIVE COMPARATOR

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

Device: ORIF: Imported miniplate and screw

Interventions

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.

Locally-made Miniplate and screw

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.

Imported Miniplate and screw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Midface fracture with the indication of surgery
• Midface fracture sustained within 2 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto mangunkusumo National Hospital

Jakarta Pusat, Central, 10430, Indonesia

Location

MeSH Terms

Conditions

Maxillofacial Injuries

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Limitations and Caveats

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

Results Point of Contact

• Title: Prasetyanugraheni Kreshanti, MD
• Organization: Plastic Surgery Division of Surgery Department of Cipto Mangunkusumo Hospital Jakarta / Faculty of Medicine Universitas Indonesia

pras_md@yahoo.com

08158732424

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: a radiologist consultant as a blinded independent evaluator will assess the bone density score in each subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 21, 2020
• Study Start: March 11, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: April 26, 2022
• Results First Posted: April 26, 2022

Record last verified: 2022-04

Locations

ID (1)