Treatment of severe ankle sprain: a pragmatic randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of three types of mechanical ankle support with tubular bandage. The CAST trial.

OBJECTIVE: To estimate the clinical effectiveness and cost-effectiveness of three methods of ankle support compared with double layer tubular compression bandage. DESIGN: A randomised controlled trial, designed to reflect practice in UK hospital emergency departments. SETTING: Eight emergency departments in England. PARTICIPANTS: Aged 16 or over with acute severe ankle sprain, unable to weight bear, no fracture. INTERVENTIONS: 584 participants were randomised to one of four treatment arms: tubular bandage, below knee cast, Aircast ankle brace or Bledsoe boot, all applied 2-3 days after presentation to allow swelling to resolve. MAIN OUTCOME MEASURES: Response to treatment was assessed using the Foot and Ankle Outcome Score and generic measures (Functional Limitations Profile, SF-12 and EQ-5D). RESULTS: When adjusted for age, sex and baseline scores, the below knee cast offered a small but statistically significant benefit at 4 weeks in terms of pain (FAOS pain difference 5.1; 95% CI 0.4-9.8), foot- and ankle-related quality of life (QoL) (FAOS QoL difference 5.9; 95% CI 0.1-11.8) and the physical component of the SF-12 (SF-12 score difference 2.2; 95% CI 0.0-4.4). Neither the Aircast brace nor the Bledsoe boot was statistically or clinically better. At 12 weeks the below knee cast was significantly better than tubular bandage in terms of pain (FAOS pain difference 5.1; 95% CI 0.3-10.0), activities of daily living (FAOS ADL difference 3.5; 95% CI 0.4-6.6), sports (FAOS sports difference 8.7; 95% CI 1.6-15.7) and QoL (FAOS QoL difference 8.7; 95% CI 2.4-15.0), and the Aircast brace was better only in terms of ankle-related QoL and mental health. The Bledsoe boot conferred no significant advantage over tubular bandage. By 9 months there were no significant differences. Based on mean direct health-care costs per participant, the Bledsoe boot was the most expensive (215 pounds) and tubular bandage the least so (1 pound 44 pence). Inclusion of indirect costs (sick leave) raised overall costs substantially and removed any significant differences between the therapies. Cost-utility analysis demonstrated that the Aircast brace [301 pounds per quality-adjusted life-year (QALY)] and below knee cast (339 pounds per QALY) were more cost-effective than the Bledsoe boot (2116 pounds per QALY). However, inclusion of indirect costs produced different rank orders, depending on the assumptions made, and results should be treated with caution. CONCLUSIONS: The below knee cast and the Aircast brace offered cost-effective alternatives to tubular bandage for acute severe ankle sprain, the former having the advantage in terms of overall recovery at 3 months. As there were no differences in long-term outcome, practitioners should consider likely compliance and acceptability to patients when choosing a brace.

Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Severe ankle sprains are a common presentation in emergency departments in the UK. We aimed to assess the effectiveness of three different mechanical supports (Aircast brace, Bledsoe boot, or 10-day below-knee cast) compared with that of a double-layer tubular compression bandage in promoting recovery after severe ankle sprains. METHODS: We did a pragmatic, multicentre randomised trial with blinded assessment of outcome. 584 participants with severe ankle sprain were recruited between April, 2003, and July, 2005, from eight emergency departments across the UK. Participants were provided with a mechanical support within the first 3 days of attendance by a trained health-care professional, and given advice on reducing swelling and pain. Functional outcomes were measured over 9 months. The primary outcome was quality of ankle function at 3 months, measured using the Foot and Ankle Score; analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN37807450. RESULTS: Patients who received the below-knee cast had a more rapid recovery than those given the tubular compression bandage. We noted clinically important benefits at 3 months in quality of ankle function with the cast compared with tubular compression bandage (mean difference 9%; 95% CI 2.4-15.0), as well as in pain, symptoms, and activity. The mean difference in quality of ankle function between Aircast brace and tubular compression bandage was 8%; 95% CI 1.8-14.2, but there were little differences for pain, symptoms, and activity. Bledsoe boots offered no benefit over tubular compression bandage, which was the least effective treatment throughout the recovery period. There were no significant differences between tubular compression bandage and the other treatments at 9 months. Side-effects were rare with no discernible differences between treatments. Reported events (all treatments combined) were cellulitis (two cases), pulmonary embolus (two cases), and deep-vein thrombosis (three cases). INTERPRETATION: A short period of immobilisation in a below-knee cast or Aircast results in faster recovery than if the patient is only given tubular compression bandage. We recommend below-knee casts because they show the widest range of benefit. FUNDING: National Co-ordinating Centre for Health Technology Assessment.

Clinical and cost effectiveness of mechanical support for severe ankle sprains: design of a randomised controlled trial in the emergency department [ISRCTN 37807450].

BACKGROUND: The optimal management for severe sprains (Grades II and III) of the lateral ligament complex of the ankle is unclear. The aims of this randomised controlled trial are to estimate (1) the clinical effectiveness of three methods of providing mechanical support to the ankle (below knee cast, Aircast brace and Bledsoe boot) in comparison to Tubigrip, and (2) to compare the cost of each strategy, including subsequent health care costs. METHODS/DESIGN: Six hundred and fifty people with a diagnosis of severe sprain are being identified through emergency departments. The study has been designed to complement routine practice in the emergency setting. Outcomes are recovery of mobility (primary outcome) and usual activity, residual symptoms and need for further medical, rehabilitation or surgical treatment. Parallel economic and qualitative studies are being conducted to aid interpretation of the results and to evaluate the cost-effectiveness of the interventions. DISCUSSION: This paper highlights the design, methods and operational aspects of a clinical trial of acute injury management in the emergency department.

Assessment of elbow joint kinematics in passive motion by electromagnetic motion tracking.

This research provides a detailed analysis of the kinematics of passive elbow motion. It quantifies how closely humeroulnar kinematics approximates rotation around a fixed axis. The results are clinically relevant for emerging treatment modalities that impose an artificial hinge to the elbow joint, such as total elbow arthroplasty and articulated external fixation. In a cadaveric study of seven specimens, we quantified ulnar rotation around the humerus in terms of instantaneous screw displacement axes calculated from electromagnetic motion-tracking source data. This methodology enabled description of the complex excursion of the elbow axis in terms of translation and orientation changes of the screw displacement axes over the range of motion. Furthermore, we analyzed the envelope of joint laxity for elbow motion under applied small varus and valgus moments. In addition, radiographic landmarks of clinical utility for axis location were evaluated by visualizing the elbow's radiographic appearance when viewed from along the calculated best-fit (average) rotation axis. Over the normal range of elbow motion, the screw displacement axis varied 2.6-5.7 degrees in orientation and 1.4-2.0 mm in translation. All instantaneous rotation axes nearly intersected on the medial facet of the trochlea. The breadth of the envelope of varus-valgus joint laxity was greatest within the initial 40 degrees of flexion and decreased by a factor of approximately two for flexion angles exceeding 100 degrees.

Quantitative assessment of osseous, ocular, and periocular changes after hypertelorism surgery.

The purpose of this study was to develop a methodology to quantify osseous, ocular, and periocular fat changes caused by correction of orbital hypertelorism to test the hypothesis that there is a quantitatively predictable relationship between the movement of the osseous orbit and that of the ocular globe. A retrospective review was performed of 10 patients who were status post unilateral or bilateral transcranial medial orbital translocation, for whom there were archival digital data for preoperative and postoperative (mean interval = 30 months) three-dimensional computed tomographic (CT) scans. In addition to standard demographic and surgical data, the clinical preoperative and postoperative interpupillary and intermedial canthal distances were recorded. By using a computer graphics workstation, the CT digital data were registered to four surgically unaltered anatomic fiducial points to allow longitudinal quantitative comparisons. The following three-dimensional measurements were made for each patient preoperatively and postoperatively: interdacryon and interocular centroid distances, and on a standard series of three horizontal and two vertical planes, the position of the medial and lateral orbital walls, and the thickness of the medial and lateral periorbital fat (20 orbits). CT digital distances were compared with similar clinical distances when possible. The age at operation ranged from 4.0 to 12.5 years (mean, 6.6 years). The reduction in interdacryon distance exceeded the reduction in intercentroid distance (mean interdacryon change = -5.3 mm versus mean intercentroid change = -2.7 mm). Although there was a strong correlation between the amount of reduction of the lateral orbital wall and intercentroid distances, there was only a moderate correlation between the reduction in the intercentroid distance and that of the medial orbital wall. Similarly, there was a moderate correlation between the decrease in thickness of the lateral periorbital fat and the reduction of intercentroid distance but not of the medial orbital fat. In conclusion, medial translocation of the orbit does not produce equivalent movement of the ocular globe; neither the intermedial canthal nor the interdacryon distance is a useful predictor of ocular centroid position; and if the goal of hypertelorism operation is reduction of interocular distance, then CT measurement of globe intercentroid distance is essential for outcome assessment.

Sagittal craniosynostosis outcome assessment for two methods and timings of intervention.

A retrospective quantitative analysis of 40 infants who underwent surgery for sagittal craniosynostosis was conducted to determine whether any difference in outcome, with respect to cranial index (cranial width/cranial length x 100), could be associated with either the age at surgery or the extent of the operation. Children < or = 13 months old at surgery and for whom there were archived computed tomography digital data preoperatively, perioperatively, and 1 year postoperatively were studied. For statistical analysis, the operation was classified as either extended strip craniectomy or subtotal calvarectomy, and the age at operation was either < or = 4 months or > 4 months. Twenty-eight patients underwent extended strip craniectomy at a mean age of 5.1 months. Their mean cranial index preoperatively was 67 versus 71 at 1 year postoperatively (p < 0.0001). Of extended strip craniectomy patients, 15 were operated on at age < or = 4 months (mean = 2.9 months) and 13 at age > 4 months (mean = 7.6 months). Mean cranial indices for age at operation groups did not achieve age-appropriate normal range values 1 year postoperatively for either group, and there was no significant difference between the mean percentages of improvement achieved (p = 0.143). Twelve patients underwent subtotal calvarectomy at a mean age of 5.2 months. Their mean cranial index preoperatively was 66 versus 74 at 1 year postoperatively (p < 0.0001). The mean cranial index in this group reached age-appropriate normal range values 1 year postoperatively. The percentage improvement in cranial index 1 year after subtotal calvarectomy was greater than after extended strip craniectomy (p = 0.003). Extended strip craniectomy for sagittal craniosynostosis does not achieve normal cranial width:length proportions, even when performed before 4 months of age. Subtotal calvarectomy for sagittal craniosynostosis does achieve normal cranial width:length proportions in the majority of the children, at least when performed within the first 13 months of life.

Photographic assessment of head shape following sagittal synostosis surgery.

A photographic assessment of the head shape of infants who had undergone surgical correction of sagittal synostosis was performed to determine (a) whether this subset could be delineated from an age-matched normal subpopulation and (b) whether two operative procedures differed in achieving normalization of head shape. This retrospective study included 8 patients who underwent extended strip craniectomy, 12 patients who underwent subtotal calvarectomy and cranial vault remodeling, and 12 age-matched subjects with no calvarial abnormality, for a total of 32 subjects. Criteria for inclusion in this study included surgery for sagittal synostosis within the first year of life and postoperative photographs at ages 4 to 8 years (mean, 4.5 years). Each set of images (frontal and lateral profile) were ranked from most to least normal by five lay observers and four professional observers. The rankings were analyzed with statistics designed for ordinal data. Differences in ranking between treatment groups were examined with Kruskal-Wallis rank sums tests. Mean ranks were calculated for lay and professional observers in an attempt to produce simpler and more generalizable results; these means were also analyzed using statistics designed for ordinal data. There was no statistical difference in the ranks of infants who had undergone a surgical correction and the normal subpopulation. In the mean rankings of the lay observers, the normal groups had the highest score mean (15.6), the group with extended strip craniectomy was second (16.0), and the subtotal calvarectomy with calvarial remodeling group was last (17.8) (p = 0.84). In the mean rankings of the professional observers, the normal groups again had the highest score mean (15.8), the subtotal calvarectomy group was second (15.9), and the extended craniectomy group was last (18.6) (p = 0.77). These results suggest that children who have undergone correction of sagittal synostosis in infancy are indistinguishable from their peers, on the basis of fully haired head shape on frontal and lateral photographs, when they begin primary school, irrespective of the type of calvarial surgery.

Limited value of preoperative cervical vascular imaging in patients with velocardiofacial syndrome.

The purpose of this two-part study was to evaluate the safety of surgical management of speech production disorders in patients with velocardiofacial syndrome without preoperative cervical vascular imaging studies. Anomalous internal carotid arteries have been shown to be a frequent feature of velocardiofacial syndrome. These vessels pose a potential risk for hemorrhage during velopharyngeal narrowing procedures. Magnetic resonance angiography, and other forms of cervical vascular imaging studies such as computerized tomography, have been advocated as aids to surgery by defining the preoperative vascular anatomy. However, it remains unclear whether these studies alter either the conduct or outcome of operations on the velopharynx. In the first part of this study, we reviewed the charts and videonasendoscopic evaluations of 39 consecutive patients with confirmed or suspected velocardiofacial syndrome who underwent sphincter pharyngoplasty or pharyngeal flap from 1978 to 1996. The charts were reviewed to determine (1) the frequency of identification of abnormal pharyngeal pulsations; (2) whether such pulsations affected the conduct of the operative procedure; and (3) whether the presence of pulsations affected surgical morbidity and/or surgical outcome. None of the patients underwent any type of cervical vascular imaging study. In the second part of this study, we surveyed plastic surgeons with numerous years of experience participating on cleft-craniofacial teams, to ascertain practice patterns relating to the management of patients with velocardiofacial syndrome. The questions related specifically to the surgeons' behavior in relation to angiography and their awareness of any cases of surgical morbidity related to the cervical vascular system in patients with velocardiofacial syndrome. We were interested in discerning both how commonly this situation arises clinically and the distribution of the various types of operative procedures in common use. Of our 39 patients, 10 patients (26 percent) had detectable pulsations on preoperative nasendoscopy. Of these, five patients underwent sphincter pharyngoplasty and five underwent pharyngeal flap procedures. Preoperative instrumental and intraoperative clinical assessment of pulsatile vessels allowed velopharyngeal reconstruction in all patients without surgical morbidity. Results of the questionnaire indicated that most cleft surgeons do not routinely order cervical vascular imaging studies for all of their patients with velocardiofacial syndrome. About half of the respondents indicated that their operative approach was influenced by information obtained from angiographic studies. None of the surgeons queried were aware of any cases of surgical morbidity related to the cervical vascular system in patients with velocardiofacial syndrome. Nearly 50 percent of surgeons use pharyngeal flap procedures most frequently, whereas 22 percent of surgeons use sphincter pharyngoplasty most frequently. Results of this study support the safety of sphincter pharyngoplasty or pharyngeal flap procedures in patients with velocardiofacial syndrome without preparatory angiography. These procedures can be performed safely, even in patients having aberrant velopharyngeal pulsations. Given the market cost of magnetic resonance angiography ($1600), one must question the cost-efficacy of magnetic resonance angiography for routine use in the velocardiofacial syndrome population.

Assessment of the AO/ASIF fracture classification for the distal tibia.

OBJECTIVES: The purpose of this study was to assess the interobserver reliability and intraobserver reproducibility of the AO/ASIF and Rüedi and Allgöwer classifications for fractures of the distal tibia, and to determine the benefit of a computed tomography (CT) scan and experience on observer agreement for several fracture characteristics, including classification. METHODS: The radiographs of forty-three fractures of the distal tibia, fourteen of which had CT scans, were assessed by groups of experienced and less-experienced observers. Each case was classified according to the AO/ASIF and Rüedi and Allgöwer systems. Several other fracture characteristics also were assessed. The kappa coefficient of agreement was calculated and used to compare the interobserver reliability and intraobserver reproducibility of the classification systems and to determine the benefit of experience and CT scans. The intraclass correlation coefficient was used to assess noncategoric data. RESULTS: Interobserver and intraobserver agreements were good when classifying fractures into AO/ASIF types and significantly better than that for the Rüedi and Allgöwer system. However, agreement was poor when classifying the fractures into AO/ASIF groups. For most assessments, the experienced group tended to have higher levels of interobserver agreement, but not intraobserver agreement. Viewing the CT scans improved agreement on the percentage of articular surface involved, but it did not improve interobserver reliability or intraobserver reproducibility for either of the classification systems. CONCLUSION: The AO/ASIF classification for fractures of the distal tibia has good observer agreement at the type level, but poor agreement at the group level. Experience tends to improve interobserver agreement, but not intraobserver agreement. Viewing CT scans does not improve agreement on classification, but it tends to improve agreement on articular surface involvement.

Results of ankle arthrodesis for treatment of supramalleolar nonunion and ankle arthrosis.

Seven patients with supramalleolar nonunions after tibial plafond fractures underwent ankle arthrodesis combined with surgical treatment of the nonunion. Stabilization of the nonunion and the ankle consisted of medial and lateral plating for two hypertrophic cases and medial external fixation for five atrophic cases. Two of the atrophic nonunions were infected, and the distal tibia below the nonunion was resected and distraction osteogenesis from a proximal level was used to fill the resulting defect. Both the nonunion and ankle arthrodesis healed in six patients in an average of 7.9 months (range, 4-20 months). The nonunion failed to heal in one patient and required a below-knee amputation. The average cost of care was $66,491 per patient. Before surgery, the average patient ankle score was 25 (range, 15-50), and at a median of 35 months' follow-up the average score was 64 (range, 18-79 months). Three patients had scores in the "good" range, two in the "fair" range, one in the "poor" range, and one was rated a treatment failure. The SF-36 scores were significantly lower than age-matched population-based normal subjects. Limb salvage was possible in six of these seven patients, but the treatment times were long, complications frequent, and the cost of care high.

Revision of the failed sphincter pharyngoplasty: an outcome assessment.

This paper reports results of surgical management of failed sphincter pharyngoplasties that were performed for velopharyngeal dysfunction. Revisional surgery consisted of tightening of the sphincter pharyngoplasty port or reinsertion of sphincter pharyngoplasty flaps following dehiscence. We critique the anatomic abnormalities associated with unacceptable vocal resonance and nasal air escape following sphincter pharyngoplasty and analyze the effect of sphincter pharyngoplasty revision on ultimate speech outcome. The results of initial sphincter pharyngoplasty surgery were evaluated in 46 patients with velopharyngeal dysfunction. Nine (20 percent) of these patients were considered surgical failures because of persistent hypernasality and/or nasal turbulence on perceptual speech evaluation at least 3 months postoperatively. These patients underwent sphincter pharyngoplasty revision and form the basis of this report. All patients who failed sphincter pharyngoplasty initially underwent both preoperative and postoperative perceptual speech evaluations, lateral phonation radiographic studies with still reference views, and flexible nasendoscopic studies. Evaluations of upper airway status were conducted by the same experienced otolaryngologist. Following sphincter pharyngoplasty revision, 7 of 9 (78 percent) patients demonstrated resolution of velopharyngeal dysfunction, and to some degree, all patients managed with revision became hyponasal. The primary cause of failure was partial or complete flap dehiscence; a secondary cause was hypotonicity of the velopharyngeal mechanism. Failure was not correlated with the level of insertion of the pharyngoplasty flaps with respect to the point of attempted velopharyngeal contact. Sphincter pharyngoplasty is an effective means of management for velopharyngeal dysfunction in many patients. The objective of removing the stigmata of velopharyngeal dysfunction without causing upper airway obstruction may not be realistic in some patients with microretrognathia (i.e., Pierre Robin sequence), in whom anatomic constraints predispose to flap dehiscence. Problems with surgical technique contributing to failure appear to be related to experience of the surgeon, and improvement in outcome can be anticipated as the "learning curve" is overcome.

Does reduced hospital stay affect morbidity and mortality rates following cleft lip and palate repair in infancy?

Insurance carriers affected decisions regarding admissions and length of stay in our hospital in 1987. Charts were reviewed retrospectively to determine whether this affected morbidity and mortality rates following cleft lip and palate operations in infants. Two periods were studied: May of 1983 through April of 1987 (group I) and April of 1987 through May of 1991 (group II). A total of 248 infants with cleft lip and/or palate underwent 398 operations: lip adhesion (74), definitive lip repair (130), and palatoplasty (194). Half were performed in each period. Admission status, length of stay, length of operation, and short-term morbidity were documented. Morbidity included spontaneous and traumatic lip dehiscence, palatal dehiscence, and palatal fistula. Intergroup analysis was performed by the chi-squared method; p < or = 0.05 was statistically significant. In group I, 93 percent of patients were admitted before surgery. In group II, 5 percent were admitted before surgery and 79 percent the day of surgery. Hospital stay decreased nearly 2 days for each operation. There was no statistically significant difference between groups in distribution of operations, length of operations, or morbidity: lip surgery complications (p = 0.263), palatoplasty complications (p = 0.624). Reductions of hospital admissions and length of stay do not affect outcome of cleft lip and palate surgery in infants. The reduction in hospital days is equivalent to a savings of $138,000 (1991 dollars).

The longitudinal orbital CT projection: a versatile image for orbital assessment.

The newer generation of CT scanners allows reconstruction of images in coronal, sagittal, and oblique planes from a single set of axial scans. These computer-generated images are described as reformatted. We have found an oblique image reformatted along the plane connecting the apex of the orbit and the center of the globe to be especially useful in assessing orbital disorders. We have named this image the longitudinal orbital projection. This projection allows direct visualization of the inferior rectus muscle and orbital floor in acute and old orbital trauma. With the image produced life size, direct measurements of enophthalmos and proptosis can be made preoperatively and postoperatively, thereby facilitating planning and follow-up. The projection is also useful in combination with other planes of reformation for the localization of tumors. The longitudinal orbital projection is now a routine part of the CT examination of the orbit in our institution. Whereas it already has become an invaluable aid in the diagnosis and follow-up of congenital and acquired orbital lesions, the longitudinal orbital projection promises to clarify the effects of trauma on the inferior rectus muscle and globe position.