PURPOSE: Owing to its putative advantages over conventional maxillomandibular fixation (MMF), open-reduction and rigid internal fixation (ORIF) is used frequently 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 attributed benefits compel a randomized controlled investigation comparing ORIF to MMF treatment. The objective of this study was to determine whether ORIF provides better clinical and functional outcomes than MMF in noncomplying type of patients with a similar range of mandible fracture severity. PATIENTS AND METHODS: From a total of 336 patients who sought treatment for mandible fractures, 142 patients with moderately severe mandible fractures were assigned randomly 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 clinician-reported number of surgical complications, patient-reported number of complaints, as well as cumulative costs of treatment. Pain intensity was measured on a 10-point scale and the 12-item General Oral Health Assessment Index 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 2 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 versus 12.5% with ORIF. Differences in the rate of patient complaints were not significant on an intent-to-treat basis, but a significant between-group difference (P = .012) favoring MMF was noted on an as-treated basis at the 1 month recall, with 40% of ORIF patients reporting greater than 1 complaint versus 18.8% of MMF patients. No significant differences were detected between the 2 treatment groups at any time point with respect to oral health-related quality of life reflected by the General Oral Health Assessment Index scores. In-patient days and total costs did not differ significantly on an intent-to-treat basis, but on an as-treated basis, patients treated with MMF had fewer in-patient days on average (1.64 vs 5.50 for ORIF) and lower average costs of treatment ($7,206 vs $26,089 for ORIF). In the intent-to-treat analyses, patients receiving MMF treatment had significantly lower (P = .05) pain scores at the 12-month recall (mean = 0.58, SE = 0.30) compared with patients assigned to ORIF (mean = 1.78, SE = 0.52). CONCLUSION: Our study did not show a clear overall benefit of the resource-intensive ORIF over conventional MMF treatment in the management of moderately severe mandible fractures in at-risk patients; our data instead suggest some cost as well as oral health quality-of-life advantages for the use of MMF in this patient population.
RCT Entities:
PURPOSE: Owing to its putative advantages over conventional maxillomandibular fixation (MMF), open-reduction and rigid internal fixation (ORIF) is used frequently 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 attributed benefits compel a randomized controlled investigation comparing ORIF to MMF treatment. The objective of this study was to determine whether ORIF provides better clinical and functional outcomes than MMF in noncomplying type of patients with a similar range of mandible fracture severity. PATIENTS AND METHODS: From a total of 336 patients who sought treatment for mandible fractures, 142 patients with moderately severe mandible fractures were assigned randomly 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 clinician-reported number of surgical complications, patient-reported number of complaints, as well as cumulative costs of treatment. Pain intensity was measured on a 10-point scale and the 12-item General Oral Health Assessment Index 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 2 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 versus 12.5% with ORIF. Differences in the rate of patient complaints were not significant on an intent-to-treat basis, but a significant between-group difference (P = .012) favoring MMF was noted on an as-treated basis at the 1 month recall, with 40% of ORIF patients reporting greater than 1 complaint versus 18.8% of MMF patients. No significant differences were detected between the 2 treatment groups at any time point with respect to oral health-related quality of life reflected by the General Oral Health Assessment Index scores. In-patient days and total costs did not differ significantly on an intent-to-treat basis, but on an as-treated basis, patients treated with MMF had fewer in-patient days on average (1.64 vs 5.50 for ORIF) and lower average costs of treatment ($7,206 vs $26,089 for ORIF). In the intent-to-treat analyses, patients receiving MMF treatment had significantly lower (P = .05) pain scores at the 12-month recall (mean = 0.58, SE = 0.30) compared with patients assigned to ORIF (mean = 1.78, SE = 0.52). CONCLUSION: Our study did not show a clear overall benefit of the resource-intensive ORIF over conventional MMF treatment in the management of moderately severe mandible fractures in at-risk patients; our data instead suggest some cost as well as oral health quality-of-life advantages for the use of MMF in this patient population.
Authors: Meade C Edmunds; T Alex McKnight; Christopher M Runyan; Brian W Downs; Jordan L Wallin Journal: JAMA Otolaryngol Head Neck Surg Date: 2019-06-01 Impact factor: 6.223