Cost Analysis of Volar Plate Fixation Versus Plaster Cast Immobilization for Intra-Articular Distal Radial Fractures.

BACKGROUND: The aim of this study was to compare the cost-effectiveness and cost-utility between plaster cast immobilization and volar plate fixation for acceptably reduced intra-articular distal radial fractures. METHODS: A cost-effectiveness analysis was conducted as part of a randomized controlled trial comparing operative (volar plate fixation) with nonoperative (plaster cast immobilization) treatment in patients between 18 and 75 years old with an acceptably reduced intra-articular distal radial fracture. Health-care utilization and use of resources per patient were documented prospectively and included direct medical costs, direct non-medical costs, and indirect costs. All analyses were performed according to the intention-to-treat principle. RESULTS: The mean total cost per patient was $291 (95% bias-corrected and accelerated confidence interval [bcaCI] = -$1,286 to $1,572) higher in the operative group compared with the nonoperative group. The mean total number of quality-adjusted life-years (QALYs) gained at 12 months was significantly higher in the operative group than in the nonoperative group (mean difference = 0.15; 95% bcaCI = 0.056 to 0.243). The difference in the cost per QALY (incremental cost-effectiveness ratio [ICER]) was $2,008 (95% bcaCI = -$9,608 to $18,222) for the operative group compared with the nonoperative group, which means that operative treatment is more effective but also more expensive. Subgroup analysis including only patients with a paid job showed that the ICER was -$3,500 per QALY for the operative group with a paid job compared with the nonoperative group with a paid job, meaning that operative treatment is more effective and less expensive for patients with a paid job. CONCLUSIONS: The difference in QALYs gained for the operatively treated group was equivalent to an additional 55 days of perfect health per year. In adult patients with an acceptably reduced intra-articular distal radial fracture, operative treatment is a cost-effective intervention, especially in patients with paid employment. Operative treatment is slightly more expensive than nonoperative treatment but provides better functional results and a better quality of life. LEVEL OF EVIDENCE: Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.

Cost-Effectiveness of Treatments after Closed Extraarticular Distal Radius Fractures in Older Adults from the WRIST Clinical Trial.

BACKGROUND: This study performs an economic analysis of volar locking plate, external fixation, percutaneous pinning, or casting in elderly patients with closed distal radius fractures. METHODS: This is a secondary analysis of the Wrist and Radius Injury Surgical Trial, a randomized, multicenter, international clinical trial with a parallel nonoperative casted group of patients older than 60 years with surgically indicated, extraarticular closed distal radius fractures. Thirty-Six-Item Short-Form Health Survey-converted utilities and total costs from Medicare were used to calculate quality-adjusted life-years and incremental cost-effectiveness ratio. RESULTS: Casted patients were self-selected and older (p < 0.001) than the randomized surgical cohorts, but otherwise similar in sociodemographic characteristics. Quality-adjusted life-years for percutaneous pinning were highest at 9.17 and external fixation lowest at 8.81. Total costs expended were $16,354 for volar locking plates, $16,012 for external fixation, $11,329 for percutaneous pinning, and $6837 for casting. The incremental cost-effectiveness ratios for volar locking plates and external fixation were dominated by percutaneous pinning and casting. The ratio for percutaneous pinning compared to casting was $28,717. Probabilistic sensitivity analysis revealed a 10, 5, 53, and 32 percent chance of volar locking plate, external fixation, percutaneous pinning, and casting, respectively, being cost-effective at the willingness-to-pay threshold of $100,000 per quality-adjusted life-year. CONCLUSIONS: Casting is the most cost-effective treatment modality in the elderly with closed extraarticular distal radius fractures and should be considered before surgery. In unstable closed fractures, percutaneous pinning, which is the most cost-effective surgical intervention, may be considered before volar locking plates or external fixation.

Surgical fixation compared with cast immobilisation for adults with a bicortical fracture of the scaphoid waist: the SWIFFT RCT.

BACKGROUND: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite. DESIGN: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study. SETTING: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs. INTERVENTIONS: Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union. MAIN OUTCOME MEASURES: The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work. RESULTS: The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery, n = 203 of 219; cast, n = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6; p = 0.27). The non-union rate was low (surgery group, n = 1; cast group, n = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset. LIMITATION: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery. CONCLUSIONS: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life. TRIAL REGISTRATION: Current Controlled Trials ISRCTN67901257. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 52. See the NIHR Journals Library website for further project information.

Fracture of the scaphoid bone (one of eight small bones in the wrist) is common in young active people. It is caused by a fall on the hand or the hand being suddenly forced backwards. The usual treatment is to rest the wrist in a plaster cast for 6­10 weeks and allow the broken bone to heal. In 1 in 10 cases in which the fracture is treated in a plaster cast, the bone does not heal and an operation is needed. In the operation, the broken bone is held still with a screw. In the last few years, it has become more common to fix the broken bone with a screw in the first few days after injury, instead of resting the wrist in a plaster cast. It is not clear if fixing the bone early with a screw, compared with resting the wrist in a cast, gives better outcomes for patients and if one treatment is better value for money for the NHS. In this study, 439 adult patients agreed either to have surgery to hold the broken scaphoid with a special screw or to have the wrist held still in a plaster cast (with surgery offered after 6 weeks to those who were still not healed). The decision about which treatment to use was made using randomisation, which is similar to tossing a coin. Patients reported their own wrist pain and function at 6, 12, 26 and 52 weeks. Information was also collected on general health, bone healing, grip strength and range of movement, complications from treatment and costs. No important differences were found in patients' wrist pain and function at 52 weeks. The bone did not heal properly in four patients in the surgery group or in nine patients in the plaster cast group at 52 weeks. For one of these patients in the surgery group and four of these patients in the plaster cast group, the bone did not join at all. Eight patients in the surgery group had further surgery following their initial operation to fix their wrist, and one patient in the cast group required repeated surgery because the bone did not join at all. The overall cost of treating with a plaster cast was lower than that of early surgery. Therefore, the findings of the study suggest that a plaster cast should be used initially and that the bone should be immediately fixed with a screw if it does not heal.

Characteristics and Hospital Costs of Spica Cast Treatment of Non-accidental-related Diaphyseal Femoral Fractures in Children Before Walking Age.

BACKGROUND: Fractures are one of the most common presentations of child abuse second only to soft tissue damage, with ∼60% of fractures being femur, humerus or tibia fractures. Although studies have shown increased health care costs associated with nonaccidental trauma (NAT), there is little data regarding the cost of NAT-associated fractures compared with accidental trauma (AT) related fractures. The purpose of this study was to consider the economic burden of NAT related femoral fractures compared with AT femoral fractures. METHODS: We performed a retrospective study of children under the age of one with femoral fractures treated with a spica cast at a Level 1 Pediatric Trauma Center between 2007 and 2016. Variables included age, sex, length of hospital stay, and estimated total billing cost obtained from this hospital's billing department. In addition, fracture site (mid-shaft, distal, proximal, and subtrochanteric) and pattern were assessed. RESULTS: Sixty children with a mean age of 7 months were analyzed. NAT was suspected in 19 cases (31.7%) and confirmed in 9 (15%) before discharge. Two groups were analyzed: the NAT group included suspected and confirmed cases of abuse (28) and the AT group contained the remaining 32 cases. There was no significant difference in the demographics between these 2 groups. Children in NAT group had a longer length of stay compared with AT group (78.9 vs. 36.7 h, P<0.001). Overall consumer price index-adjusted hospital costs were $24,726 higher for NAT group compared with AT group (P=0.024), with costs of laboratory workup, radiology, and nonorthopaedic physician fees being the top 3 components contributing to the increased costs. CONCLUSIONS: The overall incidence of NAT was 46.6% in children presenting with femoral fracture under 1 year of age. The overall hospital cost of treating fractures in the NAT group was 1.5 times higher than the AT group, with imaging charges the most significant contributor to cost difference. LEVEL OF EVIDENCE: Level III-retrospective review.

Volar Plate Fixation in Adults with a Displaced Extra-Articular Distal Radial Fracture Is Cost-Effective.

BACKGROUND: To our knowledge, a health economic evaluation of volar plate fixation compared with plaster immobilization in patients with a displaced extra-articular distal radial fracture has not been previously conducted. METHODS: A cost-effectiveness analysis of a multicenter randomized controlled trial was performed. Ninety patients were randomly assigned to volar plate fixation or plaster immobilization. The use of resources per patient was documented prospectively for up to 12 months after randomization and included direct medical, direct non-medical, and indirect non-medical costs due to the distal radial fracture and the received treatment. RESULTS: The mean quality-adjusted life-years (QALYs) at 12 months were higher in patients treated with volar plate fixation (mean QALY difference, 0.16 [bias-corrected and accelerated 95% confidence interval (CI), 0.07 to 0.27]). (The 95% CIs throughout are bias-corrected and accelerated.) In addition, the mean total costs per patient were lower in patients treated with volar plate fixation (mean difference, -$299 [95% CI, -$1,880 to $1,024]). The difference in costs per QALY was -$1,838 (95% CI, -$12,604 to $9,787), in favor of volar plate fixation. In a subgroup analysis of patients who had paid employment, the difference in costs per QALY favored volar plate fixation by -$7,459 (95% CI, -$23,919 to $3,233). CONCLUSIONS: In adults with a displaced extra-articular distal radial fracture, volar plate fixation is a cost-effective intervention, especially in patients who had paid employment. Besides its better functional results, volar plate fixation is less expensive and provides a better quality of life than plaster immobilization. LEVEL OF EVIDENCE: Economic Level I. See Instructions for Authors for a complete description of levels of evidence.

Plaster cast versus functional brace for non-surgical treatment of Achilles tendon rupture (UKSTAR): a multicentre randomised controlled trial and economic evaluation.

BACKGROUND: Patients with Achilles tendon rupture who have non-operative treatment have traditionally been treated with immobilisation of the tendon in plaster casts for several weeks. Functional bracing is an alternative non-operative treatment that allows earlier mobilisation, but evidence on its effectiveness and safety is scarce. The aim of the UKSTAR trial was to compare functional and quality-of-life outcomes and resource use in patients treated non-operatively with plaster cast versus functional brace. METHODS: UKSTAR was a pragmatic, superiority, multicentre, randomised controlled trial done at 39 hospitals in the UK. Patients (aged ≥16 years) who were being treated non-operatively for a primary Achilles tendon rupture at the participating centres were potentially eligible. The exclusion criteria were presenting more than 14 days after injury, previous rupture of the same Achilles tendon, or being unable to complete the questionnaires. Eligible participants were randomly assigned (1:1) to receive a plaster cast or functional brace using a centralised web-based system. Because the interventions were clearly visible, neither patients nor clinicians could be masked. Participants wore the intervention for 8 weeks. The primary outcome was patient-reported Achilles tendon rupture score (ATRS) at 9 months, analysed in the modified intention-to-treat population (all patients in the groups to which they were allocated, excluding participants who withdrew or died before providing any outcome data). The main safety outcome was the incidence of tendon re-rupture. Resource use was recorded from a health and personal social care perspective. The trial is registered with ISRCTN, ISRCTN62639639. FINDINGS: Between Aug 15, 2016, and May 31, 2018, 1451 patients were screened, of whom 540 participants (mean age 48·7 years, 79% male) were randomly allocated to receive plaster cast (n=266) or functional brace (n=274). 527 (98%) of 540 were included in the modified intention-to-treat population, and 13 (2%) were excluded because they withdrew or died before providing any outcome data. There was no difference in ATRS at 9 months post injury (cast group n=244, mean ATRS 74∙4 [SD 19∙8]; functional brace group n=259, ATRS 72∙8 [20∙4]; adjusted mean difference -1∙38 [95% CI -4∙9 to 2∙1], p=0·44). There was no difference in the rate of re-rupture of the tendon (17 [6%] of 266 in the plaster cast group vs 13 [5%] of 274 in the functional brace group, p=0·40). The mean total health and personal social care cost was £1181 for the plaster cast group and £1078 for the functional bract group (mean between-group difference -£103 [95% CI -289 to 84]). INTERPRETATION: Traditional plaster casting was not found to be superior to early weight-bearing in a functional brace, as measured by ATRS, in the management of patients treated non-surgically for Achilles tendon rupture. Clinicians may consider the use of early weight-bearing in a functional brace as a safe and cost-effective alternative to plaster casting. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Assessment of Anatomic Restoration of Distal Radius Fractures Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial.

Importance: The value of precise anatomic restoration for distal radius fractures (DRFs) in older adults has been debated for many decades, with conflicting results in the literature. In light of the growing population of adults aged 60 years and older, both fracture incidence and associated treatment costs are expected to increase. Objective: To determine the association between radiographic measures of reduction and patient outcomes after DRF in older patients. Design, Setting, and Participants: Data were collected from the Wrist and Radius Injury Surgical Trial (WRIST), a multicenter randomized clinical trial of DRF treatments for adults aged 60 years and older (enrollment from April 10, 2012, to December 31, 2016, with a 2-year follow-up). Data analysis was performed from January 3, 2019, to August 19, 2019. WRIST participants who completed 12-month assessments were included in the study. According to the biomechanical principle of alignment, 2-phase multivariable regression models were adopted to assess the association between radiographic measures of reduction and functional and patient-reported outcomes 12 months following treatment. Interventions: Participants were randomized to receive volar locking plate, percutaneous pinning, or external fixation. Those who opted for nonoperative treatment received casts. Main Outcomes and Measures: Hand grip strength, wrist arc of motion, radial deviation, ulnar deviation, the Michigan Hand Outcomes Questionnaire (MHQ) total score, MHQ function score, and MHQ activities of daily living score were measured at 12 months following treatment. Results: Data from 166 WRIST participants (144 [86.7%] women; mean [SD] age, 70.9 [8.9] years) found that only 2 of the 84 correlation coefficients calculated were statistically significant. For patients aged 70 years or older, every degree increase in radial inclination away from normal (22°) grip strength in the injured hand was 1.1 kg weaker than the uninjured hand (95% CI, 0.38-1.76; P = .004) and each millimeter increase toward normal (0 mm) in ulnar variance was associated with a 10.4-point improvement in MHQ ADL score (95% CI, -16.84 to -3.86; P = .003). However, neither of these radiographic parameters appeared to be associated with MHQ total or function scores. Conclusions and Relevance: The study results suggest that precise restoration of wrist anatomy is not associated with better patient outcomes for older adults with DRF 12 months following treatment. Surgeons can consider this evidence to improve quality of care by prioritizing patient preferences and efficient use of resources over achieving exact realignment. Trial Registration: ClinicalTrials.gov identifier: NCT01589692.

Increasing Brace Treatment for Pediatric Distal Radius Buckle Fractures: Using Quality Improvement Methodology to Implement Evidence-based Medicine.

BACKGROUND: Multiple randomized trials have showed equivalent outcomes and improved patient/family satisfaction using a removable brace to treat pediatric distal radius buckle fractures (DRBF). We tested the hypothesis that we could use quality improvement (QI) methodology to increase the proportion of patients with DRBF treated with removable braces at 2 tertiary care orthopaedic clinics from a baseline of 34.8% to 80%. METHODS: Clinic billing records were reviewed monthly to determine treatment (brace vs. cast) of DRBF and tracked using control charts (p-chart). Balance measures including correct application of the diagnostic criteria and algorithm were monitored. Process measures including the number of follow-up visits, radiographs obtained, and total cost of treatment were collected. Baseline data were obtained over a 3-month period, followed by a 12-month period of interventions using Plan-Do-Study-Act cycles targeting both individuals and groups of providers. RESULTS: The proportion of DRBF treated in a brace increased from a combined baseline of 34.8% to a combined 84% at the end of the study period. Following intervention, 83% (15/18) of providers began using braces for a majority of patients (defined as >67%), with only 1 provider continuing to use casts 100% of the time. Patient preference was cited as the most common reason for use of cast treatment. There was a significant decrease in the number of radiographs obtained at 1 of 2 institutions. The charges for brace treatment averaged $630 less per patient than for cast treatment, leading to an estimated medical-cost savings of $205,000 following intervention. CONCLUSIONS: Implementation of brace treatment for pediatric DRBF using QI methodology resulted in a shift toward brace treatment in the majority of patients, leading to substantial medical and nonmedical cost savings. Although patient preference was cited as the most common reason for persistent cast treatment, the data show the use of cast treatment to be more dependent upon individual provider preference. LEVEL OF EVIDENCE: Level II-therapeutic.

Financial Analysis of Closed Femur Fractures in 3- to 6-Year-Olds Treated With Immediate Spica Casting Versus Intramedullary Fixation.

BACKGROUND: Health care in America continues to place more importance on providing value-based medicine. Medicare reimbursements are increasingly being tied to this and future policy changes are expected to reinforce these trends. Recent literature has shown pediatric femur fractures in preschool-age children have equivalent clinical and radiographic outcomes when treated with spica casting or flexible intramedullary nails (IMN). We compared hospital care statistics including charges for nonoperative versus operative treatment for closed femur fractures in 3- to 6-year-olds. METHODS: An IRB-approved retrospective chart review was performed of 73 consecutive 3- to 6-year-olds treated at a regional level 1 pediatric hospital from January 1, 2009 to December 31, 2013 with an isolated, closed femoral shaft fracture. Exclusion criteria included open fractures, bilateral injury, and polytrauma. Immediate spica casting was performed in the Emergency Department or Anesthesia Procedure Unit versus IMN in the operating room. RESULTS: A total of 41 patients were treated with spica casting and 32 patients were treated operatively with flexible IMNs; 3 patients failed nonoperative care. After analysis of final treatment groups, significant differences included age at injury: 3.7 years for cast versus 5.3 years for IMN (P<0.001), time to discharge 21 versus 41 hours (P<0.001), 3.2 versus 4.4 clinic visits (P<0.001), follow-up 3.5 versus 9.4 months (P<0.001). Orthopedic surgeon charges were $1500 for casted patients versus $5500 for IMN (P<0.001). Total hospital charges were $19,200 for cast versus $59,700 for IMN (P<0.001). No difference was found between clinic charges or number of radiographs between groups. In total, 76% of cast group were discharged <24 hours from admission versus 8.6% in operative group. In the operative group, 83% had implant removal with no statistically significant charge difference between those who had implant removal versus retention. CONCLUSIONS: Treatment of pediatric femur fractures in 3- to 6-year-olds with IMN is associated with longer hospital stays, significantly greater hospital charges, longer follow-up and more clinic visits compared with spica casting. These findings are at odds with previous literature showing shorter hospital stays and decreased cost with nailing compared to traction and casting. This shows a clear difference between 2 treatments that yield similar clinical and radiographic outcomes. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial.

BACKGROUND: Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. OBJECTIVE: To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. DESIGN: A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. SETTING: Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2-4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. PARTICIPANTS: In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm2 [interquartile range (IQR) 104-683 mm2] in the intervention group and 206 mm2 (IQR 77-649 mm2) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. INTERVENTIONS: The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant's ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. MAIN OUTCOME MEASURES: The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). RESULTS: Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. LIMITATIONS: Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. CONCLUSIONS: There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. FUTURE WORK: It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN62524796. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 34. See the NIHR Journals Library website for further project information.

Outcomes and financial implications of intra-articular distal radius fractures: a comparative study of open reduction internal fixation (ORIF) with volar locking plates versus nonoperative management.

BACKGROUND: To evaluate the functional and radiographic outcomes, as well as the treatment costs, of closed displaced intra-articular distal radius fractures treated with either open reduction internal fixation (ORIF) with volar locking plates or nonoperative treatment with plaster cast immobilisation. MATERIALS AND METHODS: A total of 60 patients (32 receiving ORIF, 28 receiving nonoperative treatment) with closed intra-articular distal radius fractures were included. The mean age was 52.1 and 57.4, respectively. Functional and radiographic assessments were carried out at 12 months post-injury. Patients' treatment costs, median salaries and lengths of medical leave were obtained. RESULTS: DASH and MAYO wrist score in the ORIF group did not differ significantly from those in the nonoperative group. Apart from superior ulnar deviation in the ORIF group (p = 0.0096), differences in the range of motion of the injured wrists were not significant. Similarly, there were no significant differences in grip strength and visual analog scale for pain. Volar tilt (p = 0.0399), radial height (p = 0.0087), radial inclination (p = 0.0051) and articular step-off (p = 0.0002) were all significantly superior in the ORIF group. There was a 37-fold difference in mean treatment costs between ORIF (SGD 7951.23) and nonoperative treatment (SGD 230.52). CONCLUSION: Our study shows no difference in overall functional outcomes at 12 months for closed displaced intra-articular distal radius fractures treated with either ORIF with volar locking plates or plaster cast immobilisation, and this is independent of radiographic outcome. A longer follow-up, nevertheless, is needed to determine whether the development of post-traumatic arthritis will have an effect on function. The vast difference in treatment costs should be taken into consideration when deciding on the treatment option. LEVEL OF EVIDENCE: Level 3.

Preliminary Report-The Long Leg Cast With a Pelvic Band: A Novel Approach to Treatment of Pediatric Femur Fractures.

OBJECTIVES: The aim of the study was to describe the long leg cast with a pelvic band (LLCPB), a novel alternative to spica casting for treating femur fractures in patients aged 6 months to 6 years which requires no casting above the waist, allows for hip flexion adjustments after it is applied, and does not require an operating room for placement. METHODS: Seven children aged 7.9 months to 3.7 years with femur fractures treated with the LLCPB at a single institution were retrospectively studied. All children were casted in the emergency department under conscious sedation. Radiographic and subjective outcomes were recorded. RESULTS: All 7 children achieved acceptable reduction of their fractures without the need for re-reduction or cast wedging. Five of the 7 children were discharged from the emergency department; 1 child required 1 night of hospitalization and another child required 2 nights of hospitalization. There were no complications. The cost of placing an LLCPB at our institution was $430.46. The cost of placing a spica cast in the operating room was $5427.54 to $6465.00. CONCLUSIONS: The long leg cast with a pelvic band seems to be an acceptable treatment for children aged 8 months to 4 years with spiral femur fractures. This technique has significant advantages over traditional and modified spica casts including allowing for uninhibited toileting, weight bearing on the unaffected leg, adjustment of hip flexion at any point after placement, and easier access to the perineum, abdomen, and chest for hygienic and medical purposes. Furthermore, treatment with an LLCPB presents significant potential for cost savings.

Cost analysis and performance in distal pediatric forearm fractures: is a short-arm cast superior to a sugar-tong splint?

The aim of this study is to compare splint versus cast immobilization for maintaining alignment following closed reduction of distal 1/3 radius and both-bone forearm fractures. We performed a retrospective review of patient records between 5 and 14 years old with a distal 1/3 radius or radius and ulna fracture requiring reduction. A cost comparison was also performed using facility costs for materials. Reduction was maintained with acceptable alignment in most cases (94%). Although a sugar-tong splint slightly maintained fracture alignment better, this was not significant. Cost analysis favored initial placement of a short-arm cast ($23.59) versus a splint with later cast conversion ($26.95). Pediatric patients with a distal 1/3 radius and/or both-bone fracture requiring reduction maintain postreduction alignment irrespective of the immobilization method used, but initial placement of a short-arm cast is more cost-effective.

The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years.

BACKGROUND: Close contact casting (CCC) may offer an alternative to open reduction and internal fixation (ORIF) surgery for unstable ankle fractures in older adults. OBJECTIVES: We aimed to (1) determine if CCC for unstable ankle fractures in adults aged over 60 years resulted in equivalent clinical outcome compared with ORIF, (2) estimate cost-effectiveness to the NHS and society and (3) explore participant experiences. DESIGN: A pragmatic, multicentre, equivalence randomised controlled trial incorporating health economic evaluation and qualitative study. SETTING: Trauma and orthopaedic departments of 24 NHS hospitals. PARTICIPANTS: Adults aged over 60 years with unstable ankle fracture. Those with serious limb or concomitant disease or substantial cognitive impairment were excluded. INTERVENTIONS: CCC was conducted under anaesthetic in theatre by surgeons who attended training. ORIF was as per local practice. Participants were randomised in 1 : 1 allocation via remote telephone randomisation. Sequence generation was by random block size, with stratification by centre and fracture pattern. MAIN OUTCOME MEASURES: Follow-up was conducted at 6 weeks and, by blinded outcome assessors, at 6 months after randomisation. The primary outcome was the Olerud-Molander Ankle Score (OMAS), a patient-reported assessment of ankle function, at 6 months. Secondary outcomes were quality of life (as measured by the European Quality of Life 5-Dimensions, Short Form questionnaire-12 items), pain, ankle range of motion and mobility (as measured by the timed up and go test), patient satisfaction and radiological measures. In accordance with equivalence trial US Food and Drug Administration guidance, primary analysis was per protocol. RESULTS: We recruited 620 participants, 95 from the pilot and 525 from the multicentre phase, between June 2010 and November 2013. The majority of participants, 579 out of 620 (93%), received the allocated treatment; 52 out of 275 (19%) who received CCC later converted to ORIF because of loss of fracture reduction. CCC resulted in equivalent ankle function compared with ORIF at 6 months {OMAS 64.5 points [standard deviation (SD) 22.4 points] vs. OMAS 66.0 points (SD 21.1 points); mean difference -0.65 points, 95% confidence interval (CI) -3.98 to 2.68 points; standardised effect size -0.04, 95% CI -0.23 to 0.15}. There were no differences in quality of life, ankle motion, pain, mobility and patient satisfaction. Infection and/or wound problems were more common with ORIF [29/298 (10%) vs. 4/275 (1%)], as were additional operating theatre procedures [17/298 (6%) vs. 3/275 (1%)]. Malunion was more common with CCC [38/249 (15%) vs. 8/274 (3%); p < 0.001]. Malleolar non-union was lower in the ORIF group [lateral: 0/274 (0%) vs. 8/248 (3%); p = 0.002; medial: 3/274 (1%) vs. 18/248 (7%); p < 0.001]. During the trial, CCC showed modest mean cost savings [NHS mean difference -£644 (95% CI -£1390 to £76); society mean difference -£683 (95% CI -£1851 to £536)]. Estimates showed some imprecision. Incremental quality-adjusted life-years following CCC were no different from ORIF. Over common willingness-to-pay thresholds, the probability that CCC was cost-effective was very high (> 95% from NHS perspective and 85% from societal perspective). Experiences of treatments were similar; both groups endured the impact of fracture, uncertainty regarding future function and the need for further interventions. LIMITATIONS: Assessors at 6 weeks were necessarily not blinded. The learning-effect analysis was inconclusive because of limited CCC applications per surgeon. CONCLUSIONS: CCC provides a clinically equivalent outcome to ORIF at reduced cost to the NHS and to society at 6 months. FUTURE WORK: Longer-term follow-up of trial participants is under way to address concerns over potential later complications or additional procedures and their potential to impact on ankle function. Further study of the patient factors, radiological fracture patterns and outcomes, treatment responses and prognosis would also contribute to understanding the treatment pathway. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04180738. FUNDING: The National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 75. See the NIHR Journals Library website for further project information. This report was developed in association with the National Institute for Health Research Oxford Biomedical Research Unit funding scheme. The pilot phase was funded by the AO Research Foundation.

Using softcast to treat torus fractures in a paediatric emergency department.

Wrist torus fractures in children are a frequent reason for Emergency Department (ED) visits. Torus fractures traditionally were treated with a backslab cast in the Children's ED and then referred to the Fracture Clinic. Guidelines were developed in order to standardise the care for children who attended the ED with a torus fracture. All patients who were seen & treated by the Advanced Nurse Practitioner (ANP) over a one year period with a diagnosis of a torus fracture were treated with immobilisation in a softcast. 119 patients met the criteria for inclusion. There were no adverse events recorded and no patient required subsequent visits to the Fracture Clinic. There was a cost savings of €18,596 as compared with the normal referral pathway to the Fracture Clinic.

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults.

BACKGROUND: Proximal humeral fractures account for 5-6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults. DESIGN: A pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years. SETTING: Recruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation. PARTICIPANTS: Adults (aged ≥ 16 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck. INTERVENTIONS: The choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups. MAIN OUTCOME MEASURES: The primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected. RESULTS: The mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0-48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) -1.33 to 2.84; p = 0.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing < £20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses. CONCLUSIONS: Current surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50850043. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 24. See the NIHR Journals Library website for further project information.

Costs analysis and comparison of usefulness of acute MRI and 2 weeks of cast immobilization for clinically suspected scaphoid fractures.

BACKGROUND AND PURPOSE: Fractures of the scaphoid are often not detected on initial plain radiographs. Conventional management of clinically suspected scaphoid fractures is cast immobilization for 2 weeks and then reassessment. Early MRI is a diagnostic alternative. We compared the cost and usefulness of the early MRI diagnostic strategy with that of conventional management. PATIENTS AND METHODS: This prospective pseudo-randomized study included patients between 18 and 49 years of age who attended Bergen Accident and Emergency Department, Bergen, Norway during 1 year in 2009-2010, after sustaining an acute wrist trauma in the previous week and with a clinically suspected scaphoid fracture. 61 patients were investigated with acute MRI, while 63 patients received standard treatment as a control group. We used cost-minimization analysis to estimate the cost of the 2 patient groups. RESULTS: Concerning cost, there were no statistically significant differences in the total direct medical costs or in indirect costs between the groups. Concerning usefulness, patients in the MRI group without a fracture (n = 35) used a cast for fewer days (mean 1 day) than patients in the control group with no fractures (n = 52) (mean 14 days; p < 0.001). They had less than half the number of days on sick leave than patients in the control group (mean 7 days vs. 15 days; p = 0.002). INTERPRETATION: In a Norwegian setting, an early MRI was of value in patients with clinically suspected scaphoid fracture and normal plain radiographs.

Protótipo para realização de cranioplastia de baixo custo / Prototype for cranioplasty low cost in postoperative decompressive craniotomy

Objetivo: O presente trabalho propõe uma técnica para realização de cranioplastia com metilmetacrilato em formas pré-moldadas e esterilizadas visando evitar cranioplastia com prototipagem pré-moldada.Método: Conforme rotina apresentada, o flap ósseo realizado para craniotomia descompressiva é armazenado em recipientes com formol e enviado para o serviço de patologia do hospital. Quando realizamos a cranioplastia, utilizamos o flap ósseo armazenado para realização dos moldes que serão utilizados na cranioplastia. Resultado: O resultado estético é muito bom e os índices de complicação e infecção são baixos. Conclusão: Apresenta resultados estéticos semelhantes aos casos de prototipagemcom baixo custo na confecção.

Objective: This paper proposes a technique for cranioplasty with methyl methacrylate and molded into shapes pre-sterilized to avoid aiming cranioplasty with pre molded prototyping. Method: As presented routine bone flap performed to decompressive craniectomy is stored in containers with formalin and sent to the pathology service of the hospital. When we performed the cranioplasty, we used the bone flap stored for realization of molds that will be used in cranioplasty. Result: The aesthetic result is very good and the rates of complication and infection are lo

Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial.

BACKGROUND: Ulcers of the heel in diabetes are the source of considerable suffering and cost. In the absence of specific treatments, it has been suggested that removable, lightweight fibreglass heel casts may both promote healing and reduce discomfort and pain. The aim of the study is to assess the effectiveness and cost-effectiveness of fibreglass heel casts in the management of heel ulcers. METHODS/DESIGN: This is an observer-blind, randomised controlled trial in which participants with diabetes and heel ulcers (NPUAP/EPUAP grades 2, 3 or 4 and present for 2 or more weeks) are randomised to receive either usual care plus lightweight fibreglass heel casts or usual care alone. Randomisation is undertaken by random number sequence generation incorporated as part of the electronic case record form, and is stratified by both ulcer area (less than versus equal to or greater than 1 cm(2)) and NPUAP/EPUAP grade. Participants are followed every two weeks until healing or for 24 weeks. The primary outcome measure is healing at or before 24 weeks and maintained for 4 weeks. Secondary outcomes include (i) ulcer-related outcomes: time to healing, change in ulcer area, minor and major amputation, secondary infection and (ii) patient-related outcomes: local pain, mood and function (EQ-5D), impact of the ulcer (Cardiff Wound Impact Schedule) and survival. Cost-effectiveness will be assessed using a decision analytic model to estimate costs from the perspective of the UK NHS and personal social services and health outcomes, including percent healing and Quality Adjusted Life Years gained.Safety will be documented as adverse and serious adverse device effects. DISCUSSION: If it is possible to confirm significant clinical benefit and/or cost-effectiveness, this would have direct implications for the management of this distressing and costly complication of diabetes TRIAL REGISTRATION NUMBER: ISRCTN62524796 Registered 29 March 2011.

Cost-effectiveness of the Ponseti method for treatment of clubfoot in Pakistan.

BACKGROUND: Clubfoot is disabling, with an incidence of 0.9/1,000 live births to 7/1,000 live births. It affects mobility, productivity, and quality of life. Patients are treated surgically or non-surgically using the Ponseti method. We estimated the cost per patient treated with both methods and the cost-effectiveness of these methods in Pakistan. METHODS: Parents of patients treated, either surgically or with the Ponseti method, at the Indus Hospital's free program for clubfoot were interviewed between February and May 2012. We measured the direct and indirect household expenditures for pre-diagnosis, incomplete treatment, and current treatment until the first brace for Ponseti method and the first corrective surgery for surgically treated patients. Hospital expenditure was measured by existing accounts. RESULTS: Average per-patient cost was $349 for the Ponseti method and $810 for patients treated surgically. Of these, the Indus hospital costs were $170 the for Ponseti method and $452 for surgically treated patients. The direct household expenditure was $154 and $314 for the Ponseti and surgical methods, respectively. The majority of the costs were incurred pre-diagnosis and after inadequate treatment, with the largest proportion spent on transportation, material, and fee for service. The Ponseti method is shown to be the dominant method of treatment, with an incremental cost-effectiveness ratio of $1,225. CONCLUSIONS: The Ponseti method is clearly the treatment of choice in resource-constrained settings like Pakistan. Household costs for clubfoot treatment are substantial, even in programs offering free diagnostics and treatments and may be a barrier to service utilization for the poorest patients.