Mandibular FractureNCT02850861
A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
A study testing Condylar reductor in people with Mandibular Fracture, run by Junhui Cui.
Trial summary
In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mandibular Fracture
- What is being tested?
- Condylar reductor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.
Who cannot join
- patients refused to participate in the clinical trial;
- condylar fracture dislocation was not obvious, conservative treatment can be used;
- mandibular condylar comminuted fracture;
- mandibular condyle need to be reconstructed.
About this study
In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.
Read the detailed description
In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.
- Conditions
- Mandibular Fracture
- Being tested
- Condylar reductor
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condylar reductorDevice
A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | In this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures. Receives: Device: Condylar reductor |
| The control group | No intervention | In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative reduction time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular FractureStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junhui Cui
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Sponsor-investigator, Junhui Cui, West China Hospital
- Investigators
- Lei Liu, MD, Study director, West China Hospital of Stomotalogy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850861
- Sponsor's protocol ID
- WCH-01
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
- ClinicalTrials.gov ID
- NCT02850861
- Acronym / sponsor ID
- WCH-01
- Conditions
- Mandibular Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Junhui CuiUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.
Detailed description
In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Device: Condylar reductorIn this group, the condylar reductor was applied in the surgical treatment of mandibular condylar fractures. |
| The control group | No intervention | –In this group, traditional surgical instruments were applied in the surgical treatment of mandibular condylar fractures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.
Key exclusion criteria (4 listed)
- patients refused to participate in the clinical trial;
- condylar fracture dislocation was not obvious, conservative treatment can be used;
- mandibular condylar comminuted fracture;
- mandibular condyle need to be reconstructed.
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 |
|---|---|---|
| Condylar reductorA new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction. | Device | The experimental group |
Primary outcome
intraoperative reduction time
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- The West China Hospital of Stomatology has long been ranked as one of the national top hospitals in ChinaLink provided by the sponsor.
Related trials for Mandibular Fracture
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Not yet recruiting
Clinical And Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
Mandibular Angle Fractures, Mandibular Body Fractures
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
Pediatric Mandibular Fracture
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
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.
Lei Liu, MD study director
West China Hospital of Stomotalogy
Questions about this trial
What is this clinical trial studying?
A study testing Condylar reductor in people with Mandibular Fracture, run by Junhui Cui.
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 1 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: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intraoperative reduction time (time frame: intraoperative). 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 1 Aug 2016.