Maxillofacial InjuriesNCT04279925
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
A study testing ORIF (Open reduction internal fixation): locally-made miniplate and screw and ORIF: Imported miniplate and screw in people with Maxillofacial Injuries and Maxillofacial Prosthesis Implantation, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Injuries, Maxillofacial Prosthesis Implantation, Fracture Fixation, Internal
- What is being tested?
- ORIF (Open reduction internal fixation): locally-made miniplate and screw and ORIF: Imported miniplate and screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Mar 2020to 31 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Midface fracture with the indication of surgery
- Midface fracture sustained within 2 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto mangunkusumo National Hospital
Jakarta Pusat, Central, 10430
About this study
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
- Being tested
- ORIF (Open reduction internal fixation): locally-made miniplate and screw, ORIF: Imported miniplate and screw
- Medical subject headings
- Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIF (Open reduction internal fixation): locally-made miniplate and screwDevice
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.
ORIF: Imported miniplate and screwDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Locally-made Miniplate and screw | Experimental | Locally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. Receives: 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. Receives: Device: ORIF: Imported miniplate and screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Screw Loosening (Yes/No)
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.
Measured: 3 months
Tissue Reaction (Yes/No)
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start11 Mar 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Why it stopped: Aerosol risk of COVID-19 spread resulting a slow subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Maxillofacial InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Prasetyanugraheni Kreshanti, SpBP-RE (KKF), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279925
- Sponsor's protocol ID
- 1085/UN2.F1/ETIK/PPM.0002/2019
- Status last verified
- Apr 2022
- First submitted
- 10 Feb 2020
- Last updated
- 26 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
- ClinicalTrials.gov ID
- NCT04279925
- Acronym / sponsor ID
- 1085/UN2.F1/ETIK/PPM.0002/2019
- Conditions
- Maxillofacial Injuries, Maxillofacial Prosthesis Implantation, Fracture Fixation, Internal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Aerosol risk of COVID-19 spread resulting a slow subject recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Posted 26 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locally-made Miniplate and screw | Experimental | Device: ORIF (Open reduction internal fixation): locally-made miniplate and screwLocally-made miniplate and screw produced by the Faculty of Engineering Universitas Indonesia. |
| Imported Miniplate and screw | Active comparator | Device: ORIF: Imported miniplate and screwBiomet® miniplate 1.5 and screw 1.5 produced by Biomet, included in the Lorenz® Plating System Midface. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Midface fracture with the indication of surgery
- Midface fracture sustained within 2 weeks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORIF (Open reduction internal fixation): locally-made miniplate and screwFracture 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 | Locally-made Miniplate and screw |
| ORIF: Imported miniplate and screwFracture 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. | Device | Imported Miniplate and screw |
Primary outcome
Bone Density
Time frame: 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.
2 secondary outcomes
Screw Loosening (Yes/No)
Time frame: 3 months
Tissue Reaction (Yes/No)
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORIF (Open reduction internal fixation): locally-made miniplate and screw and ORIF: Imported miniplate and screw in people with Maxillofacial Injuries and Maxillofacial Prosthesis Implantation, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Density (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.