Mandible FractureNCT01876979
Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.
A study testing IMF Screws and Erich Arch Bars in people with Mandible Fracture, run by Christiana Care Health Services at 2 sites in United States.
Trial summary
Determining the cost effectiveness, based on the time duration of application, of two methods of wiring the jaws together during surgery to repair mandible fractures. One technique is more expensive but faster in application, while the other is less expensive and takes more time to apply. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- IMF Screws and Erich Arch Bars
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Apr 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70
- Patients with no greater than one (1) open fracture of the tooth-bearing mandible
- Mandibular angle fractures ± Ramus or subcondylar fracture
- Body/symphysis ± subcondylar
- Isolated angle fracture
- Isolate subcondylar fractures
Show all 9Show fewer
- Bilateral subcondylar fractures
- Any condylar head/neck fracture requiring treatment
- Patients who are candidates for treatment of their fractures in the operating room setting
Who cannot join
- Patients younger than 18 or older than 70
- Patients with developing tooth buds anterior to the second molars
- Patients with inadequate stability of occlusion
- Edentulism
- Unstable vertical and horizontal stops to the occlusion
- Patients with disorders affecting bone healing, metabolism and turnover
Show all 16Show fewer
- Those patients on bisphosphonates, oral or IV
- Patients with evidence of intrabony pathology of the mandible or maxilla
- The presence of any of the following:
- Greater than one (1) open fracture of the tooth-bearing mandible
- Bilateral angle fractures are exempt from this
- Comminuted fractures of the mandible
- Concomitant infection, or osteomyelitis of the mandible
- Mechanism of injury
- Pathologic fracture
- Gun-shot wounds
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Christiana Care Hospital
Newark, Delaware, 19718
Wilmington Hospital
Wilmington, Delaware, 19801
About this study
Official title: Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?
Determining the cost effectiveness, based on the time duration of application, of two methods of wiring the jaws together during surgery to repair mandible fractures. One technique is more expensive but faster in application, while the other is less expensive and takes more time to apply.
Read the detailed description
Purpose:
To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery.
- Conditions
- Mandible Fracture
- Being tested
- IMF Screws, Erich Arch Bars
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMF ScrewsDevice
Also called Synthes IMF screws
stainless steel screws placed in bone
Erich Arch BarsDevice
Surgical braces wired around teeth
| Study group | Role | What they receive |
|---|---|---|
| IMF Screws | Active comparator | Use of IMF screws as a means to wire the jaws. Receives: Device: IMF Screws |
| Erich Arch Bars | Active comparator | Use of Erich Arch bars in the wiring of the jaws. Receives: Device: Erich Arch Bars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Time duration for the application of device, in minutes.
Measured: Time duration of placement of device in operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Extended study duration
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 Mandible 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Meara, Christiana Care Health Services
- Investigators
- Daniel Meara, MD, Principal investigator, Christiana Care Health ServicesDaniel J Meara, MS, MD, DMD, Study chair, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876979
- Sponsor's protocol ID
- CCC# 33082
- Other IDs
- DDD# 602252
- Status last verified
- May 2017
- First submitted
- 11 Jun 2013
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erich Arch Bars vs. IMF Screws for Placement of Maxillomandibular Fixation: Which is More Time Effective in the Operating Room Setting?
- ClinicalTrials.gov ID
- NCT01876979
- Acronym / sponsor ID
- CCC# 33082
- Conditions
- Mandible Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extended study duration
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determining the cost effectiveness, based on the time duration of application, of two methods of wiring the jaws together during surgery to repair mandible fractures. One technique is more expensive but faster in application, while the other is less expensive and takes more time to apply.
Detailed description
Purpose:
To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMF Screws | Active comparator | Device: IMF ScrewsUse of IMF screws as a means to wire the jaws. |
| Erich Arch Bars | Active comparator | Device: Erich Arch BarsUse of Erich Arch bars in the wiring of the jaws. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18-70
- Patients with no greater than one (1) open fracture of the tooth-bearing mandible
- Mandibular angle fractures ± Ramus or subcondylar fracture
- Body/symphysis ± subcondylar
- Isolated angle fracture
Key exclusion criteria (16 listed)
- Patients younger than 18 or older than 70
- Patients with developing tooth buds anterior to the second molars
- Patients with inadequate stability of occlusion
- Edentulism
- Unstable vertical and horizontal stops to the occlusion
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 |
|---|---|---|
| IMF ScrewsAlso: Synthes IMF screwsstainless steel screws placed in bone | Device | IMF Screws |
| Erich Arch BarsSurgical braces wired around teeth | Device | Erich Arch Bars |
Primary outcome
Time
Time frame: Time duration of placement of device in operating room
Time duration for the application of device, in minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- 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.
Daniel Meara, MD principal investigator
Christiana Care Health Services
Daniel J Meara, MS, MD, DMD study chair
Christiana Care Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMF Screws and Erich Arch Bars in people with Mandible Fracture, run by Christiana Care Health Services at 2 sites in United States.
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 9 inclusion and 16 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 28 Jun 2017). 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?
Time (time frame: Time duration of placement of device in operating room). 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 28 Jun 2017.