Three-Dimensional Upper Lip and Nostril Sill Changes After Cleft Alveolus Reconstruction Using Autologous Bone Grafting Versus Recombinant Human Bone Morphogenetic Protein-2 :

In older cleft patients, alveolar bone grafting may be associated with poor wound healing, graft exposure, recurrent fistula, and failure of tooth eruption. A new procedure using a resorbable collagen matrix with bone morphogenetic protein (BMP)-2 was compared with traditional iliac crest bone graft to close alveolar defects in older patients. Skeletally mature patients with an alveolar cleft defect undergoing alveolar cleft repair were divided into either group 1 (BMP-2, experimental) or group 2 (traditional iliac graft, control) (n = 21). Bone healing was assessed with intraoral examination and NewTom scans (three-dimensional, Panorex, periapical films). Donor-site morbidity was determined with pain surveys. Overall cost and length of hospital stay were used to examine economic differences. Preoperative and follow-up (1 year) intraoral examinations revealed fewer complications (11 percent versus 50 percent) and better estimated bone graft take in group 1 compared with group 2. Panorex and three-dimensional computed tomographic scans showed enhanced mineralization in group 1 compared with group 2. Volumetric analysis showed group 1 had a larger percentage alveolar defect filled with new bone (95 percent) compared with group 2 (63 percent). Donor-site pain intensity and frequency were significant in group 2 but not group 1. The mean length of stay was greater for group 2 compared with group 1. In addition, the mean overall cost of the procedure was greater in group 2 ($21,800) compared with group 1 ($11,100). For this select group of late-presenting alveolar cleft patients, the BMP-2 procedure resulted in improved bone healing and reduced morbidity compared with traditional iliac bone grafting.

Adverse effects of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal surgery have previously been observed. However, because of its size, scope, and nature, the US Food and Drug Administration's database of postmarketing reports is useful for detecting new and unexpected safety concerns. To characterize adverse events reported to the FDA; to characterize off-label use of rhBMP-2. Review of adverse events reported to the FDA after the use of rhBMP-2 (INFUSE Bone Graft) in spinal surgery. The Manufacturer and User Facility Device Experience database was searched for the brand name "infuse bone graft," for reports received from July 2, 2002, through August 31, 2011. Adverse events were reviewed, summarized, and classified by an MD. For each report, the most important clinical entity was identified as the principal adverse event. Off-label uses were summarized. Of 834 reports, four (0.5%) described procedures in which rhBMP-2 was used in accordance with the approved indication. Nearly half of all the reports, 370 (44.4%), stated that the patient required revision surgery or other invasive interventions to address the reported adverse event. Swelling, fluid collections, osteolysis, pain/radiculopathy, heterotopic bone, pseudarthrosis, surgical site infections and other wound complications, thromboembolic events, respiratory distress, cancer, and other events were reported. Because of their duration, scope, and expense, prospective studies designed to estimate the risk of rare adverse events may be impractical. Despite its imperfections, postmarketing surveillance helps to narrow the focus by revealing patterns and prioritizing topics for further research. One should not extrapolate from these results to the rhBMP-2 experience as a whole; the findings reported here might not be representative. This analysis indicates that serious adverse events can occur after the use of rhBMP-2 in spinal surgery and raises many points that surgeons may wish to consider when deciding when and how to use this product in their patients. Published by Elsevier Inc.

The arthritic glenoid is typically in retroversion and restoration to neutral version is recommended. While a method for measurement of glenoid version using axial computed tomography (CT) has been reported and has been widely accepted, its accuracy and reproducibility has not been established. In 33 patients scheduled for shoulder arthroplasty, glenoid version and maximum wear of the glenoid articular surface were measured with respect to the scapular body axis on 2-dimensional- (2D) CT slices as well as on 3-dimensional- (3D) reconstructed models of the same CT slices. Clinical CT scans were axially aligned with the patient's torso but were almost never perpendicular to the scapular body. The average absolute error in version measured on the 2D-CT slice passing through the tip of the coracoid was 5.1 degrees (range, 0 - 16 degrees , P < .001). On high-resolution 3D-CT reconstructions, the location of maximum wear was most commonly posterior and was missed on the clinical 2D-CT slices in 52% of cases. Error in measuring version and depth of maximum wear can substantially affect the determination of the degree of correction necessary in arthritic glenoids. Accurately measuring glenoid version and locating the direction of maximum wear requires a full 3D-CT reconstruction and analysis. Copyright 2010 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.