Kevin M. Kelly

Cranial Growth Unrestricted during Treatment of Deformational Plagiocephaly

Objectives: The Dynamic Orthotic Cranioplasty (DOC) BandTM is a cranial orthosis used to treat deformational plagiocephaly. The ability of this device to redirect growth and thus, improve craniofacial asymmetry has raised concerns regarding the potential restriction of cranial growth. The purpose of this study was to evaluate the growth of the head during correction of plagiocephaly. Methods: The study sample consisted of 190 children: 81 females (42.6%) and 109 males (57.4%) All patients had been diagnosed with nonsynostotic plagiocephaly, did not have other significant medical conditions, were compliant with DOC protocol, and had complete anthropometric measurements at entrance and exit from treatment. Growth of the head was evaluated using head circumference, maximum cranial width and maximum cranial length. Correction of plagiocephaly was evaluated by documenting the reduction of craniofacial asymmetry of the cranial vault, skull base and face. Paired t tests were used to assess the significance of changes in these anthropometric measurements. Differences were considered significant if p < 0.05. Results: Average entrance age was 6.5 months with a mean treatment time of 4.1 months. Statistical analysis demonstrated highly significant reductions in asymmetry in all three regions (p < 0.001). More importantly, these corrections were achieved with synchronous growth of the skull as demonstrated by highly significant increases (p < 0.001) in head circumference, maximum cranial width and maximum cranial length. Conclusions: These findings document statistically significant increases in cranial growth in association with concomitant reductions of the cranial asymmetries associated with deformational plagiocephaly.

Cranioplasty in the growing canine skull using demineralized perforated bone

This study was designed to test the hypothesis that demineralized perforated bone matrix implant from canine skull and tibia induces new bone formation within the calvarial defect comparable with the bone induced by autogenous graft. We also were interested in determining whether demineralized perforated bone matrix implants from membranous bone have greater osseoinductive capacity in the calvarial area than demineralized perforated bone matrix implants from endochondral bone. Forty 12-week-old purebred beagles were used. Group I consisted of animals with unrepaired surgically created calvarial defects healed by secondary intention (n = 10). Group II consisted of animals with surgically created calvarial defects in which the bone was removed and replaced with an autograft (n = 10). Group III consisted of animals with surgically created calvarial defects in which the bony defect was closed with a demineralized perforated bone matrix implant obtained from beagle calvaria (n = 10). Group IV consisted of animals with surgically created calvarial defects in which the bony defect was closed with a demineralized perforated bone matrix implant obtained from beagle tibia (n = 10). The two control groups (I and II) allowed us to isolate the inductive capacity of demineralized perforated bone matrix implants and compare it with the healing of the bone defects left unrepaired or repaired with calvarial autografts. Animals were sacrificed after 8 and 12 weeks. In the present study we were able to verify that demineralized perforated bone matrix implants are well accepted in the calvarial defects with little tissue reaction and remarkably little osteoclastic activity. In arguing for the osseoinductive potential of demineralized perforated bone, we must realize that it is likely that much of the bone consists of demineralized implant that has been invaded by host cells along with new bone in the area of the implant. This study revealed no statistically significant differences between new bone formation following the insertion of demineralized perforated bone matrix implants of the tibia or calvarium. (Plast. Reconstr. Surg. 96: 770, 1995.)

Results of multidisciplinary management of bilateral cleft lip and palate at the Iowa Cleft Palate Center

Bilateral cleft of the lip and palate is by many standards the most complex and severe form of the defect. The complexity and severity of the defect require an unusual degree of cooperation among all specialists and especially between the surgeon and the orthodontist. There are no published findings that we know about in which comprehensive data from a number of disciplines are reported for the same group of bilateral cleft patients. Fifty randomly selected patients with bilateral complete clefts were examined by the Iowa team and two orthodontists from other institutions. The evaluations revealed that a large number of patients over the age of 10 have multiple residual problems requiring further treatment. Only 23 percent of the older patients studied were judged to have had treatment completed by the surgeon, speech pathologist, and orthodontist. It is very difficult to state whether the results obtained by our team can be considered satisfactory because there are no comparable studies that have attempted to evaluate the same parameters in multidisciplinary management.

Multidisciplinary treatment results for patients with isolated cleft palate.

Fifty-eight patients with cleft palate only who had received treatment in the Department of Otolaryngology-Head and Neck Surgery at the University of Iowa were examined for treatment results. Forty-one (70.7 percent) of the 58 patients showed a syndrome or suggestive factors. An unusually high percentage (36 percent) of the 58 patients required secondary surgery for velopharyngeal dysfunction or showed indications for surgery at examination. Some but not all of the relatively low success rate appears related to surgical experience. Speech proficiency, hearing acuity, and dental status were within normal limits or nearly so. The 20 patients with pharyngeal flap surgery were doing well, with minimal indications of functional obstruction.

Development of a new three-dimensional cranial imaging system.

The development of a new three-dimensional (3D) imaging system designed to obtain a digital image of an infant’s cranium is described. This system is intended to replace the manual plaster-casting technique currently used during the process of fabricating cranial remodeling bands. The system uses 18 triangulated digital cameras and the projection of random infrared patterns to capture a 360° image of an infant’s cranium instantaneously, including the face and top of the head. Accuracy was calculated by comparing models digitized with this system with the same models digitized with high-precision inspection equipment. Safety was documented under guidelines established by the American Council of Governmental Industrial Hygienists. Images were acquired in 0.008 seconds and processed for viewing in software within 2.5 minutes. Accuracy was calculated to be ±0.236 mm. Hazard analysis confirmed the system to be safe for direct continuous exposure. The data acquired may be viewed as a point cloud, wire frame, or surface on which a digital photograph (ie, texture) is automatically overlaid. Physical models are created by exporting the digital data to a multiaxis milling machine or stereolithography machine. Quantitative data (linear and surface measurements, curvature, and volumes) can be obtained directly from the digital data. The cranial imaging system is a safe and accurate method of obtaining digital 3D images of an infant’s cranium. Along with the obvious clinical and manufacturing benefits, it also has significant potential as a research tool for documenting the natural history and evaluating the treatment of plagiocephaly.

Car Seats, Infant Carriers, and Swings: Their Role in Deformational Plagiocephaly

&NA; The recent increase in incidence of deformational plagiocephaly is commonly believed to be associated with the American Academy of Pediatrics “Back to Sleep” campaign. Other factors, however, may contribute to the development of this condition. During the past decade, we have seen a number of infants whose deformities seem to be associated with the extended use of car seats, infant carriers, bouncy seats, and infant swings. Having recognized that notes about usage were being routinely recorded in the margins of our clinical records, we began collecting information on the amount of time infants were spending in these devices. In this report, we describe our findings and document the related cranial deformities. The data and photographs were collected between 1998 and 2000 and reviewed to determine the amount of time children with deformational plagiocephaly spent in these devices. During the three‐year study period, 56.6% of the infants spent less than 1.5 hrs, 28.6% spent 1.5 to 4 hrs, and 14.8% spent more than 4 hrs/day in these devices. In addition, 5.7% slept in one of these devices during their first several months of life, frequently because of problems with reflux. These infants often developed an increase in posterior head height and “squaring” or “cornering” of the head. Normal use of car seats, carriers, swings and bouncy seats is not a concern; however, caution is warranted for infants who spend extended periods of time in these devices. The constant pressure these devices apply to the back of the cranium may perpetuate the deformation.

Does interference with mucoperiosteum and palatal bone affect craniofacial growth? An experimental study in beagles.

This study was designed to assess the effects of raising mucoperiosteal flaps and exposing palatal bone at the time of palatoplasty. Using 62 beagle puppies as subjects, we tested the hypothesis that raising mucoperiosteal flaps does not interfere with craniofacial growth. We further hypothesized that the size of the area of bone exposed following palatoplasty does affect subsequent craniofacial growth. The animals were divided into four groups: two control groups (unoperated and unrepaired) and two experimental groups. In the first experimental group, two-flap palatoplasty was used to close the surgically induced palatal defect, leaving narrow strips (0 to 2.5 mm) of bone exposed lateral to the flaps. In the second group, one flap was raised to close the defect, leaving a wide area (5 to 6 mm) of palatal bone exposed on one side. Thirty-four direct craniometric measurements were analyzed. Animals that had elevation of both mucoperiosteal flaps with narrow strips of denuded bone on both sides had less severe craniofacial growth aberrations than those in which the defect was left unrepaired or was repaired with one mucoperiosteal flap leaving a wider area of bare bone exposed. These findings suggest that raising mucoperiosteal flaps is less detrimental to craniofacial growth than leaving large areas of exposed palatal bone.

The Influence of Lip Repair with and without Soft-tissue Undermining on Facial Growth in Beagles

The present study was designed to test the hypothesis that undermining of the soft tissues on the surface of the maxilla at the time of lip repair in unilateral cleft lip, alveolus, and palate results in more severe craniofacial growth aberrations than lip repair alone. Sixty-seven purebred beagles were used in this experiment. The animals were divided into four groups: two control groups (unoperated and unrepaired) and two experimental groups (lip repair without undermining and lip repair with undermining). Lip pressures were monitored in all groups. Significantly higher lip pressures were observed in animals with soft-tissue undermining. Cephalometric measurements were analyzed using univariate and multivariate techniques. The results of this study indicate that lip repair performed with soft-tissue undermining results in more severe craniofacial growth aberrations than lip repair performed alone.

A comparative study of the effects of biodegradable and titanium plating systems on cranial growth and structure : experimental study in beagles

An experimental study was conducted in beagles to assess the effects of biodegradable and titanium plating systems on cranial growth and structure. Forty-eight 9-week-old purebred beagles were used in this study. To avoid any effects of sexual dimorphism, we used only female beagles. The animals were divided in three groups: sham-operated controls, n = 16; beagles implanted with commercially available titanium plates and screws, n = 16; and beagles implanted with biodegradable plates and screws, n = 16. The biodegradable plating system developed by Storz Instrument Company (St. Louis, Mo.) for use in the craniofacial skeleton does not require another procedure to remove plates and screws once the healing process is completed. To assess the dynamics of changes in cranial growth under the influence of two different plating systems, we conducted two identical studies during two different time periods: 6 weeks and 12 weeks. Using two different time frames allowed us to assess changes in the biodegradable material and in the bone and soft tissue surrounding this material. Statistical analysis revealed no significant differences in the gross cranial structure among the three groups. This finding suggests that the biodegradable plating system has no adverse effect on cranial growth. The material does resorb and/or disintegrate between 6 and 12 weeks after insertion. The rate of resorption is approximately 5.3 microns per day. The bone and soft tissue surrounding the biodegradable implant exhibited very limited inflammation and foreign body reaction. Bony overgrowth was frequently found over the plating system.

Simultaneous cleft lip and palate repair: an experimental study in beagles.

This study was designed to test the hypothesis that simultaneous lip and palate repair results in more severe craniofacial growth aberrations than lip repair or palate repair performed separately. Seventy-six purebred beagles were divided into five groups. Two of these groups were controls (unoperated and unrepaired animals); the three remaining groups were experimental (in one group only the lip was repaired, in another only the palate was repaired, and in the last the lip and palate were repaired simultaneously). Cephalometric measurements were analyzed using univariate and multivariate statistical techniques. In multivariate analysis, stepwise multiple regression and discrimination were applied to precisely assess the effects of the various surgical procedures. The results of this study indicate that simultaneous lip and palate repair results in more severe craniofacial growth aberrations than lip repair or palate repair performed separately.