Champy Versus AO for Mandible Fractures (Mand)

November 19, 2013 updated by: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University

A Comparison of 2mm Plates and Screws With Larger Plates Ans Screws in the Treatment of Mandibular Fractures

Patients who sustain a broken lower jaw have traditionally been treated in one of three ways. The first involves having their teeth and jaws being wired together for a period of 4 to 6 weeks in order to allow the broken jaw to heal. The second and third ways involve a surgical procedure that requires exposing the broken bones and stabilizing them with metal plates and screws that allow the patient to be able to function relatively normally during the healing period. One surgical method uses small plates and screws while the alternate method uses large plates and screws. Currently there are two schools of thought with respect to what plates and screws should be used. One group supports the use of large rigid plates due to the increased strength of the plate. The use of the larger and stronger plates is the principle behind the AO technique, which was originally developed in the 1970's in Switzerland and is now the more popular technique in the USA. The other group supports the use of smaller plates and screws which must be placed in certain anatomical positions to allow the natural muscular forces that exist on the jaw to stabilize the break and facilitate complete healing of the broken bone. This technique was developed in France by Maxime Champy in the 1970's and is the standard of care throughout Australasia and parts of Europe. This technique is simpler, quicker and cheaper. The need for patients to maintain a diet with softer foods is considered by many to be important for success if the less rigid and smaller plates are going to be used. Many critics of the Champy technique feel that less compliant patient populations as might be seen in a county hospital make the technique less readily suited to these populations. This is contrary to published data from Europe, Australia and recently the USA.

The question of interest is whether the smaller plates and screws are equally as effective in the treatment of broken lower jaws in an urban county hospital? If they are equally effective, then is there any benefit in terms of fewer patient complications and decreased health costs? If the smaller plates and screws are not adequate, then will a modification of the original Champy technique improve their usefulness? Patients who present with a broken lower jaw who require surgery will be treated in one of three ways. Some patients will be treated with the larger plates and screws by an attending surgeon who routinely uses large plates and screws for broken lower jaws. Another group of patients will be treated with the smaller plates and screws using the Champy principles. A third group of patients will also be treated with the smaller plates and screws but using a modification of the original Champy technique that involves the use of additional small plates and screws for added stability. Patients will then be followed over a three month period to evaluate for healing of the broken jaw. The three techniques will be then be compared.

Larger plates/ screws and the smaller plates/ screws are both the standard of care. Regional differences throughout the USA has continued to ensure differences of opinion with regard to which technique is better although historically the larger plates/screws has been more popular in the USA.

Study Overview

Status

Completed

Conditions

Detailed Description

All patients will have ORIF of their fractured mandible under general anesthesia. Patients will either be treated with small 2 mm plates and screws according to Champy principles (or a modified Champy technique that utilizes additional 2mm plates/screws) or larger plates/screws (2.3mm or larger) according to the AO principles. No patients will have their teeth wired together so that all patients will be able to function normally. All patients will have an immediate post operative orthopantogram to verify adequacy of the fracture reduction. Patients will be discharged as soon as is medically appropriate.

Patient Assessment

Patients will be assessed regularly at 1 week, 3 weeks, 6 weeks and 3 months to ensure continued healing of the fracture. This is a typical post-operative follow-up schedule for all fracture patients. As is the standard of care, orthopantogram x-rays will be taken at 6 weeks and 3 months to assess fracture healing. Additional x-rays will only be taken if the clinical picture is suggestive of inadequate healing or infection. Additional data regarding the presence of infection, nonunion, fibrous union, malunion, malocclusion, facial nerve weakness and inferior alveolar nerve paresthesia will be recorded at each follow-up visit. Additional complications will also be recorded and managed as necessary.

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 89 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who present with a fractured mandible

Description

Inclusion Criteria:

  • all patients with a fractured mandible
  • age 11 to 89

Exclusion Criteria:

  • Comminuted fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
This group will have 2 mm plates and screws placed according to Champy principles
2
This group will have 2 mm plates placed according to modified Champy principles
3
This group will have larger (2.3 mm or greater) plates and screws placed according to the AO technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fracture healing
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
malocclusion
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Gary F Bouloux, MD, DDS, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00000444

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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