Outcomes and Survivorship of Biomet Microfixation Total Joint Replacement System: Results From an FDA Postmarket Study.

PURPOSE: In February 2011, the Food and Drug Administration issued a postmarket surveillance order to all manufacturers of temporomandibular joint (TMJ) implants in the United States. The objective of the present study was to measure implant subsequent surgical intervention (SSI) among patients who had undergone TMJ reconstruction with the Biomet TMJ replacement system (Zimmer Biomet, Warsaw, IN). MATERIALS AND METHODS: A prospective observational study was conducted by sending a questionnaire to patients who had received a Biomet TMJ replacement system from 1995 to 2010 in the United States. The questionnaire was sent annually from 2012 to 2015. The primary endpoint was the SSIs. SSIs included both device removal and reoperations. Kaplan-Meier survival analysis was used to determine the survivorship, and Cox proportional hazard regression analysis was performed to evaluate the preoperative diagnosis and SSI. RESULTS: The mean age at implantation was 46.6 ± 12.5 years, with a gender distribution of 86.1% female. Data from 499 joints in 319 subjects were collected as a part of the survey. The mean follow-up time was 8.6 ± 3.9 years (range, 2-20 years). The first SSI frequency was 11.2% (4.2% removal rate and 7.0% reoperation rate). The survivorship rate (Kaplan-Meier) was 96% at 3 years, 94% at 5 years, and 86% at 10 years. The mean interval to failure using a survival function to determine the time to SSI (Greenwood's formula) was 13.5 ± 0.193 years. The most common causes of SSI included adhesion removal (2.6%; 13 of 498), heterotopic bone/ankylosis (2.0%; 10 of 498), and infection (1.6%; 8 of 498). CONCLUSIONS: The results from the present study are consistent with the reported survivorship rates for other orthopedic devices (5-year survival for total hip or knee arthroplasty, 95.9 and 97.2%, respectively). The etiology of SSIs in the Biomet TMJ replacement system was primarily secondary to biologic failure (ie, adhesions, heterotopic bone, and infection).

Edentulism Is Associated With More Severe Obstructive Sleep Apnea Syndrome.

PURPOSE: The relationship between edentulism and the severity of obstructive sleep apnea syndrome (OSAS) is not well established. The purpose of the present study was to evaluate the relationship of edentulism on the severity of OSAS compared with equally at-risk dentate subjects. PATIENTS AND METHODS: We performed a retrospective matched cohort study of edentulous and dentate subjects with OSAS matched by age, gender, and body mass index (BMI). The primary predictor variable was dentate status (dentate vs edentulous) and the primary outcome variable was the OSAS severity measured using apnea hypopnea index (AHI). The secondary outcome variables were the Epworth sleepiness scale (ESS) score and nadir oxygen level. Inferential, univariate, and multivariate statistical analyses were completed. RESULTS: A total of 26 subjects (13 edentulous and 13 dentate) were included in the present study. The edentulous subjects had more severe OSAS compared with the equally at-risk dentate subjects, with statistically significant differences between the 2 groups for AHI (47 ± 25 vs 23 ± 11; P = .0044) and ESS score (16 ± 4.2 vs 11 ± 5.2; P = .0094). A significant multivariate effect for OSAS was only found for the covariates of gender (female vs male; P = .016) and edentulism status (yes vs no; P = .01), with no significant interaction between them (P = .24). CONCLUSIONS: Within the limits of the present study, edentulous subjects, compared with dentate subjects, and controlling for age, gender, and BMI, had more severe OSAS, as evidenced by the significantly increased AHI and ESS. Male gender and edentulism are significant risk factors for more severe OSAS compared with equally at-risk dentate patients.

Maxillomandibular Advancement for Obstructive Sleep Apnea Is Associated With Very Long-Term Overall Sleep-Related Quality-of-Life Improvement.

PURPOSE: We sought to evaluate the effect of maxillomandibular advancement (MMA) on long-term subjective quality of life (QOL) in obstructive sleep apnea (OSA). PATIENTS AND METHODS: This was a retrospective cohort analysis of long-term postoperative QOL issues in patients who underwent MMA for polysomnogram-confirmed severe OSA (apnea-hypopnea index > 30). The inclusion criteria included a history of MMA in the treatment of OSA, willingness to complete the Ottawa Sleep Apnea Questionnaire (OSA-Q) survey, and minimum of 5-year follow-up. The OSA-Q was used to evaluate sleep quality, daytime function, physical health, mental and emotional health, and sexual health. The independent variable was time of follow-up, and the dependent variables were the responses to the OSA-Q. Data collection was completed, and statistical analyses were performed with the 1-sample Wilcoxon signed rank test with a median score of 3 (no change) to evaluate for significant changes in the categories. P < .05 was considered statistically significant. RESULTS: A total of 27 of 51 eligible patients (53% response rate) responded to the questionnaire (15 men and 12 women). The average postoperative age was 59.1 ± 11.7 years, with an average follow-up period of 12.7 ± 3.8 years. Statistically significant long-term QOL improvements from MMA for OSA were found in overall QOL (mode, 4; P < .05) and in the categories of personal satisfaction (mode, 5; P < .01), sleep quality (mode, 4; P < .01), and functional outcomes (mode, 4; P < .05). CONCLUSIONS: MMA for OSA provided significant improvement in overall patient QOL as well as personal satisfaction, sleep quality, and functional outcomes at very long-term follow-up at an average of more than 12 years after surgery. MMA for OSA produces significant very long-term subjective QOL improvement.

Oral Functional Behavior and Neurosensation After Adult Maxillomandibular Advancement for Obstructive Sleep Apnea in the Long-Term.

PURPOSE: We evaluated and correlated the long-term subjective perioral neurosensory deficit intensity and oral functional behavior difficulty after maxillomandibular advancement (MMA) for adult obstructive sleep apnea (OSA). PATIENTS AND METHODS: We implemented a long-term retrospective cohort study of adult subjects who had undergone MMA for OSA, with subjective assessments using 7-point visual analog scales. Adult subjects who had undergone MMA for OSA with a minimum of 5 years of follow-up data available who had agreed to participate were included in the present study. The 1-sample Wilcoxon signed rank test and Spearman correlation coefficients were used to evaluate the data. Statistical significance was set at the P < .05 level. RESULTS: Of the 51 eligible subjects, 27 (53% response rate) were included in the present study. The mean age preoperatively was 59.8 years, with a mean follow-up of 12.7 years. Most subjects (85%) had, overall, reported the long-term subjective perioral neurosensory deficit intensity to be none to very mild (mode, 0; mean, 2.20; P < .05) and oral functional behavior to have none to very mild difficulty (mode, 0; mean, 1.6; P < .05). Statistically significant moderate to strong positive correlations between the subjective assessments of oral functional behavior and perioral neurosensory deficit intensity were found for chewing (r = 0.74), kissing (r = 0.50), eating (r = 0.80), speaking (r = 0.81), and drooling (r = 0.67). CONCLUSIONS: Within the limitations of the present study, more than 12 years after MMA for severe OSA, most subjects (85%) had minimal to no subjective perioral neurosensory deficits and very minimal to no difficulty in the subjective assessment of oral functional behavior. Strong positive correlations between the subjective decreased perioral neurosensory deficit intensity and decreased oral function behavior difficulty suggest that the return of perioral neurosensation might contribute to the return of oral functional behavior.

Maxillomandibular Advancement for Obstructive Sleep Apnea Produces Long-Term Horizontal Advancement of the Maxilla and Mandible.

PURPOSE: Because limited data have been reported, the purpose of the present study was to evaluate the long-term craniofacial cephalometric skeletal changes associated with maxillomandibular advancement (MMA) for obstructive sleep apnea (OSA). MATERIALS AND METHODS: We performed a retrospective cephalometric cohort study of craniofacial skeletal changes in patients who had undergone MMA for OSA. The primary predictor and outcome variables were time and the change in SNB over time, respectively. Digitized cephalometric radiographs were analyzed by an independent third-party cloud-based tracing software for 6 skeletal landmarks at 3 points-preoperatively, within 1 month postoperatively, and at the last follow-up evaluation. Post hoc stratification bidimensional analyses by gender and preoperative age and body mass index (BMI) were performed. Clinically significant results were determined as a greater than 2% change from baseline. Univariate and bivariate statistics were computed, and the statistical significance level was set at P < .05. RESULTS: Thirty consecutive subjects with an even gender distribution were included in the present study. The average preoperative age, apnea hypopnea index, and BMI were 43.7 years, 59.8, and 39.3 kg/m2. The average follow-up duration was 10.7 years (range, 5.6 to 18.8). Statistically and clinically significant long-term postoperative changes were found only for SNA (+4.9° or +6.0%; P < .001) and SNB (+3.8° or +4.9%; P < .001). Stratification by gender and median preoperative age and BMI did not find any statistically or clinically significant results. CONCLUSIONS: Within the limitations of the present study, MMA for OSA produced statistically and clinically significant long-term cephalometric skeletal horizontal angular advancement of the maxilla and mandible of 6 and 4.9%, respectively, independently of gender, age, or BMI.

Maxillomandibular Advancement for Severe Obstructive Sleep Apnea Is a Highly Skeletally Stable Long-Term Procedure.

PURPOSE: To evaluate long-term clinically significant cephalometric skeletal stability with maxillomandibular advancement (MMA) for obstructive sleep apnea (OSA). MATERIALS AND METHODS: We performed a retrospective cohort analysis of long-term clinically significant skeletal stability in patients who underwent MMA for OSA. The primary predictor and outcome variables were the occurrence of and time to loss of clinically significant skeletal stability, respectively, at sella-nasion-B point (SNB). The inclusion criteria included severe OSA (apnea-hypopnea index > 30), MMA, diagnostic preoperative and postoperative lateral cephalometric radiographs, and a minimum of 5 years of follow-up. Digitized cephalometric radiographs were analyzed at 3 time points: preoperatively, postoperatively, and at last follow-up. Statistical analyses included Kaplan-Meier time-to-loss of clinical stability analysis, the log-rank test, and the Cox proportional hazards model for hazard ratio determination for the influence of the following independent variables on loss of clinical stability: gender, age at the time of surgery, time to follow-up, and amount of surgical movement. Post hoc stratification for bone grafting was completed. Statistical significance was set at the P < .05 level. RESULTS: Thirty consecutive patients with an even gender distribution and average follow-up period of 10.7 years were included in this study. Preoperatively, the average age was 43.7 years; apnea-hypopnea index, 59.8; and body mass index, 39.3. Half of the cohort had clinically significant loss of skeletal stability at sella-nasion-A point (SNA), SNB, and A point-nasion-B point (ANB) approximately 13 years after surgery, with no statistically significant difference between SNA, SNB, and ANB curves (χ2 = 0.12) independent of the independent variables at SNB (χ2 = 1.9), SNA (χ2 = 1.3), or ANB (χ2 = 1.3). The average hazard ratio ranged from 0.89 to 1.02. CONCLUSIONS: Within the limitations of this study, MMA in the treatment of severe OSA is a highly skeletally stable long-term procedure independent of gender, age at the time of surgery, time to follow-up, and amount of surgical movement.

Early major medical complications after surgical management of obstructive sleep apnea: a retrospective cohort analysis and case series.

PURPOSE: The purpose of this study was to determine the frequency and relative risk (RR) of early postoperative major medical complications after surgery for the management of obstructive sleep apnea. PATIENTS AND METHODS: This was a retrospective cohort analysis of patients who had undergone surgery for the treatment of polysomnogram-confirmed obstructive sleep apnea at 2 hospitals in Pittsburgh, PA, between 1992 and 2013. Early postoperative major medical complications were defined as either a life-threatening complication requiring intensive care unit intervention or death within the immediate hospital course. Standard demographic data, apnea-hypopnea index, Epworth Sleepiness Score, minimum nocturnal oxygen saturation, and body mass index were collected. The 2-tailed independent t test, Fisher exact test, and RR with 95% confidence interval were used. RESULTS: A total of 267 consecutive patients who underwent surgery for obstructive sleep apnea and met the inclusion criteria were included in this study. A total of 6 patients (6 of 267, 2.2%) had early major medical postoperative complications. When stratified by surgical group (intrapharyngeal vs extrapharyngeal), there were 162 intrapharyngeal patients with 2 complications (1.2%) and 105 extrapharyngeal patients with 4 complications (3.8%). We found no statistically significant difference in frequency (2 of 162 intrapharyngeal patients [1.2%] vs 4 of 105 extrapharyngeal patients [3.8%], P = .17) or RR (3.1; 95% confidence interval, 0.58 to 16.55; P = .1885) between the groups. There were statistically significant differences for mean age, apnea-hypopnea index, Epworth Sleepiness Score, minimum nocturnal oxygen saturation, and body mass index between the surgical groups. CONCLUSIONS: The overall frequency of early major medical postoperative complications in upper airway surgery for obstructive sleep apnea is low, with no statistically significant difference in frequency and RR between intrapharyngeal and extrapharyngeal surgery. There may, however, be a clinically significance difference in RR possibly because of associated differences in risk factors between the groups.

Pre-emptive analgesia with pregabalin and celecoxib decreases postsurgical pain following maxillomandibular advancement surgery: a randomized controlled clinical trial.

PURPOSE: The purpose of this study was to determine the efficacy of pre-emptive analgesia with pregabalin and celecoxib on narcotic consumption and perceived pain in adult patients undergoing maxillomandibular advancement surgery for obstructive sleep apnea. PATIENTS AND METHODS: This was a prospective, randomized, double-blinded, placebo-controlled study of adult patients undergoing elective maxillomandibular advancement surgery for obstructive sleep apnea. The groups received a masked 1-time preoperative oral dose of pregabalin 150 mg and celecoxib 400 mg (experimental group) or lactose powder 2 g (placebo group). In the postoperative period, pain management consisted of intravenous morphine patient-controlled analgesia and oral oxycodone 5 mg and acetaminophen 325 mg. Patients completed a daily pain and narcotic log. Statistical significance between group means was determined by the 2-tailed independent t test. RESULTS: There were statistically significant differences between the pregabalin plus celecoxib and placebo groups in average intravenous morphine consumption per 4-hour interval (6.0 ± 5.9 vs 9.3 ± 7.9 mg; P < .05), mean daily narcotic pill consumption (2.9 ± 2.9 vs 6.8 ± 1.8 pills; P < .05), and mean daily visual analog scale scores (4.3 ± 3.5 vs 5.5 ± 5.0; P < .05). CONCLUSION: Within the limitations of this study, a 1-time preoperative oral dose of pregabalin and celecoxib before adult maxillomandibular advancement surgery for obstructive sleep apnea decreased mean intravenous morphine consumption, mean daily narcotic pill consumption, and mean patient perceived pain.

Combined elliptical window genioglossus advancement, hyoid bone suspension, and uvulopalatopharyngoplasty decrease apnea hypopnea index and subjective daytime sleepiness in obstructive sleep apnea.

PURPOSE: The objective and subjective outcomes of combined mandibular elliptical window genioglossus advancement, hyoid bone suspension, and uvulopalatopharyngoplasty procedures have not been evaluated. This study was conducted to evaluate postoperative changes in the apnea hypopnea index (AHI) and subjective daytime sleepiness with this combination of procedures in the surgical management of obstructive sleep apnea (OSA). PATIENTS AND METHODS: This was a retrospective cohort analysis of patients who had undergone combined elliptical window genioglossus advancement, hyoid bone suspension, and uvulopalatopharyngoplasty performed at Allegheny General Hospital (Pittsburgh, PA) from July 1, 2006 through December 31, 2008 for polysomnogram-confirmed OSA. Inclusion criteria included patients who had undergone the combined elliptical window genioglossus advancement, hyoid bone suspension, and uvulopalatopharyngoplasty procedures with preoperative and minimum 6-month postoperative AHI and Epworth Sleepiness Scale (ESS). Statistical significance between mean differences of pre- and postoperative AHI and ESS was determined with the 2-tailed paired t test and 95% confidence intervals. RESULTS: Thirteen male patients (average age, 43.0 ± 2.4 yr; average follow-up, 18.0 ± 3.6 months) were included in this study. There were statistically significant differences between mean pre- and postoperative AHI (28.3 vs 12.1; P < .05; mean change, -16.2; 57.2% decrease) and ESS (15.2 vs 6.3; P < .05; mean change, -8.9; 58.6% decrease). CONCLUSION: The combined mandibular elliptical window genioglossus advancement, hyoid bone suspension, and uvulopalatopharyngoplasty procedures for the treatment of OSA decrease AHI and subjective daytime sleepiness.

Cephalometric soft tissue analysis of combined elliptical-window genioglossus advancement and hyoid suspension for obstructive sleep apnea.

PURPOSE: This study sought to determine the changes in cephalometric facial profile soft tissue measurements after simultaneous elliptical-window genioglossus advancement and hyoid suspension procedures for obstructive sleep apnea. PATIENTS AND METHODS: A retrospective analysis of preoperative and postoperative lateral cephalometric soft tissue changes in 23 consecutive patients who had undergone combined elliptical-window genioglossus advancement and hyoid bone suspension for polysomnogram-confirmed obstructive sleep apnea. Six cephalometric soft tissue measurements of the lower face were evaluated: pogonion (Pg'-Pg), menton (Me'-Me), gnathion (G'-G), lower lip (LI-L1i), B point (B-B'), and horizontal distance from subnasale perpendicular to the soft tissue chin at the level of pogonion (SN-Pg'). Statistical analysis was conducted with the paired Student t test (with 95% confidence interval of difference between means) and found significant for P < .05. Post hoc power analysis was conducted. RESULTS: There were no statistically significant differences among all 6 preoperative and postoperative cephalometric, radiographic soft tissue measurements of the lower facial profile. CONCLUSIONS: The combined elliptical-window genioglossus advancement and hyoid suspension procedures for obstructive sleep apnea do not significantly change the cephalometric lower facial profile. In patients with an adequate lower facial profile with base-of-tongue obstruction who require surgical management of obstructive sleep apnea without alteration of their lower facial profile, this procedure does not significantly alter the preoperative facial profile.

Pseudogout of the temporomandibular joint: immediate reconstruction with total joint arthroplasty.

BACKGROUND: Pseudogout of the temporomandibular joint (TMJ) is a rare disorder with <40 reported cases in the English-language literature. It is usually treated with surgical resection and condylectomy alone. METHODS: We report the case of a 68-year-old woman presenting with a preauricular mass resulting from calcium pyrophosphate deposition (pseudogout) in the TMJ, who underwent surgical resection with immediate reconstruction. RESULTS: Open surgical resection to completely remove the mass confirmed substantial erosion of the condyle and disc, necessitating condylectomy and discectomy. The joint was thereafter immediately reconstructed by total joint arthroplasty using a Christensen TMJ implant sized to the patient's anatomy. The patient was able to resume a regular diet and demonstrated marked improvement in her interincisal opening. CONCLUSION: Immediate reconstruction of the TMJ with total joint arthroplasty is a safe and effective measure following removal of this (and potentially other) TMJ lesions.

Outcome assessment of patients undergoing maxillofacial procedures for the treatment of sleep apnea: comparison of subjective and objective results.

PURPOSE: The purpose of this study was to compare the subjective findings of the Epworth Sleepiness Scale (ESS) to the objective findings of the overnight sleep study (OSS) in 57 patients who underwent phase I and phase II surgery for the correction of obstructive sleep apnea (OSA). PATIENTS AND METHODS: Forty-two patients in phase I category (hyoid suspension, palatal surgery, and/or genioglossus advancement) and 15 patients in phase II category (maxillomandibular advancement) were examined. All patients had an OSS and completion of an ESS preoperatively and at a minimum of 8 weeks postoperatively. The results of each test were evaluated to examine any relationship between the improvements of the findings of the OSS to the changes in the ESS. RESULTS: Using accepted criteria, phase I surgery produced an 80% success rate and phase II surgery produced a greater than 95% success rate in both the respiratory disturbance index and the ESS. CONCLUSIONS: 1) Both phase I and phase II procedures are effective in treating OSA. 2) Phase II appears to be more effective in treating OSA using both objective and subjective evaluations. 3) Improvement in ESS scores and excessive daytime sleepiness seems to parallel the improvement in OSS scores in patients undergoing surgical correction of OSA.