Do the Benefits of Rigid Internal Fixation of Mandible Fractures Justify the Added Costs? Results From a Randomized Controlled Trial

Abstract

Context-Owing to its putative advantages over conventional maxillomandibular fixation (MMF), open-reduction and rigid internal fixation (ORIF) is frequently used to treat mandible fractures, particularly in noncompliant patients. The resource intensive nature of ORIF, the large variation in its use and the lack of systematic studies substantiating ORIF's attributed benefits compel a randomized controlled investigation comparing ORIF to MMF treatment.Objectives-To determine whether ORIF provides better clinical and functional outcomes than MMF in non-complying type of patients with a similar range of mandible fracture severity.Study Design-A prospective randomized controlled study with repeated assessments over a 1-year follow-up. Setting-Inner-city Level-1 Trauma centerMethods-From a total of 336 patients who sought treatment for mandible fractures, 142 patients with moderately-severe mandible fractures were randomly assigned to receive MMF or ORIF and followed prospectively for 12 months. A variety of clinician and patient-reported measures were used to assess outcomes at the 1, 6 and 12 months follow-up visits. These measures included clinicianreported number of surgical complications, patient-reported number of complaints, as well as Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript cumulative costs of treatment., Pain intensity was measured on a 10-point scale and the 12-item General Oral Health Assessment Index (GOHAI) was used to assess the patients' oral health related quality of life. Because the protocol allowed clinical judgment to overrule the randomly assigned treatment, outcomes were compared on an "intent-to-treat" basis as well as in terms of actual treatment received.Results-The sociodemographic and clinical characteristics of the injury did not differ among the two groups On an intent-to-treat basis, the difference in complication rates was not significant but favored MMF; 8.1% of patients developed complications with MMF vs. 12.5% with RIF. Differences in the rate of patient complaints were not significant on an intent-to-treat basis, but a significant between-group difference (p = 0.012) favoring MMF was noted on an as-treated basis at the 1 month recall, with 40% of ORIF patients reporting >1 complaint vs. 18.8% of MMF patients. No significant differences were detected between the two treatment groups at any time point with respect to oralhealth related quality of life reflected by the GOHAI scores. In-patient days and total costs did not differ significa...

The Financial Burden of Mandibular Trauma

“…These discrepancies have been attributed to OR time, implant costs, length of hospital stay, and complication rate. 15,16 In the 2008 randomized controlled trial by Shetty et al, 17 336 patients were randomly assigned to ORIF versus CRIMF for treatment of mandibular fractures. In this study there was a significant elevation in cost and length of hospital stay for the ORIF group; there was no significant difference in clinical outcomes aside from a reported quality-of-life questionnaire at 6 months postoperatively.…”

“…Level 1 trauma and academic centers throughout the country are similarly burdened by treating mandibular trauma and seek to improve cost efficiency in their practice. 15,17,33 …”

Outcome of Comminuted Mandibular Fracture Repair Using an Intraoral Approach for Osteosynthesis

“…Whereas costs can be reduced significantly when mandibular fractures are treated only with MMF, 24 one cannot deny the advantage of the needlessness of prolonged MMF. Mandibulomaxillary fixation can be opened directly after the surgery in most cases when ORIF is performed, allowing the patient to eat soft foods just shortly after the operation.…”

Is There Enough Evidence to Regularly Apply Bone Screws for Intermaxillary Fixation in Mandibular Fractures?

“…30 Current standards for IMF, such as arch bars, are time consuming and can be damaging to the periodontium and painful during treatment, thus stimulating a growing demand for more costeffective and patient-friendly techniques. 4,25,31 This study was conducted to evaluate the evidence supporting IMFSs as a new standard for IMF in mandibular fracture treatment, hypothesizing that IMFSs are superior to arch bars to achieve intraoperative IMF. A systematic electronic search was performed using the PubMed, Embase, and Cochrane databases.…”