Champy Versus AO for Mandible Fractures

NCT ID: NCT00628849

Last Updated: 2013-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-06-30

Brief Summary

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.

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.

Conditions

Mandibular Injuries

Keywords

Mandible; fracture; Champy; AO technique

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

This group will have 2 mm plates and screws placed according to Champy principles

No interventions assigned to this group

2

This group will have 2 mm plates placed according to modified Champy principles

No interventions assigned to this group

3

This group will have larger (2.3 mm or greater) plates and screws placed according to the AO technique

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Comminuted fractures

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary F Bouloux, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00000444

Identifier Type: -

Identifier Source: org_study_id