15 results on '"Mahabier KC"'
Search Results
2. Functional outcome of operative versus nonoperative treatment of humeral shaft fractures: results of a prospective multicenter cohort study
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Hartog, DD, additional, Mahabier, KC, additional, Verhofstad, MHJ, additional, VanLieshout, EMM, additional, and HUMMER, Investigators, additional
- Published
- 2020
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3. Hemiarthroplasty versus Nonoperative Treatment of Comminuted Proximal Humeral Fractures: Results of the ProCon Multicenter Randomized Clinical Trial
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Hartog, DD, additional, Schep, NWL, additional, Mahabier, KC, additional, De, Zwart AJM, additional, Nijs, S, additional, Verhofstad, MHJ, additional, Van, Lieshout EMM, additional, and ProCon, Investigators, additional
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- 2020
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4. Humeral shaft fracture: systematic review of non-operative and operative treatment.
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Van Bergen SH, Mahabier KC, Van Lieshout EMM, Van der Torre T, Notenboom CAW, Jawahier PA, Verhofstad MHJ, and Den Hartog D
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- Humans, Fracture Fixation, Internal methods, Fracture Healing physiology, Bone Plates adverse effects, Humerus, Treatment Outcome, Fracture Fixation, Intramedullary adverse effects, Humeral Fractures surgery, Humeral Fractures complications, Radial Neuropathy etiology
- Abstract
Introduction: Humeral shaft fractures can be treated non-operatively or operatively. The optimal management is subject to debate. The aim was to compare non-operative and operative treatment of a humeral shaft fracture in terms of fracture healing, complications, and functional outcome., Methods: Databases of Embase, Medline ALL, Web-of-Science Core Collection, and the Cochrane Central Register of Controlled Trials (CENTRAL) were systematically searched for publications reporting clinical and functional outcomes of humeral shaft fractures after non-operative treatment with a functional brace or operative treatment by intramedullary nailing (IMN; antegrade or retrograde) or plate osteosynthesis (open plating or minimally invasive). A pooled analysis of the results was performed using MedCalc., Results: A total of 173 studies, describing 11,868 patients, were included. The fracture healing rate for the non-operative group was 89% (95% confidence interval (CI) 84-92%), 94% (95% CI 92-95%) for the IMN group and 96% (95% CI 95-97%) for the plating group. The rate of secondary radial nerve palsies was 1% in patients treated non-operatively, 3% in the IMN, and 6% in the plating group. Intraoperative complications and implant failures occurred more frequently in the IMN group than in the plating group. The DASH score was the lowest (7/100; 95% CI 1-13) in the minimally invasive plate osteosynthesis group. The Constant-Murley and UCLA shoulder score were the highest [93/100 (95% CI 92-95) and 33/35 (95% CI 32-33), respectively] in the plating group., Conclusion: This study suggests that even though all treatment modalities result in satisfactory outcomes, operative treatment is associated with the most favorable results. Disregarding secondary radial nerve palsy, specifically plate osteosynthesis seems to result in the highest fracture healing rates, least complications, and best functional outcomes compared with the other treatment modalities., (© 2023. The Author(s).)
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- 2023
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5. Functional and Clinical Outcomes After Plate Osteosynthesis Versus Intramedullary Nailing of a Humeral Shaft Fracture: The Results of the HUMMER Multicenter, Prospective Cohort Study.
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Den Hartog D, Mahabier KC, Van Bergen SH, Verhofstad MHJ, and Van Lieshout EMM
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- Adult, Humans, Prospective Studies, Fracture Fixation, Internal methods, Bone Plates adverse effects, Postoperative Complications etiology, Humerus, Treatment Outcome, Fracture Healing, Fracture Fixation, Intramedullary adverse effects, Humeral Fractures surgery
- Abstract
Background: Plate osteosynthesis (referred to throughout as plating) and intramedullary nailing (referred to throughout as nailing) are the most common operative strategies for humeral shaft fractures. However, it is undecided which treatment is more effective. This study aimed to compare functional and clinical outcomes of these treatment strategies. We hypothesized that plating would result in an earlier recovery of shoulder function and fewer complications., Methods: From October 23, 2012, to October 3, 2018, adults with a humeral shaft fracture, OTA/AO type 12A or 12B, were enrolled in a multicenter, prospective cohort study. Patients were treated with plating or nailing. Outcome measures included the Disabilities of the Arm, Shoulder and Hand (DASH) score, Constant-Murley score, ranges of motion of the shoulder and elbow, radiographic healing, and complications until 1 year. Repeated-measure analysis was done with correction for age, sex, and fracture type., Results: Of the 245 included patients, 76 were treated with plating and 169 were treated with nailing. Patients in the plating group were younger, with a median age of 43 years compared with 57 years for the nailing group (p < 0.001). The mean DASH score after plating improved faster over time, but did not differ significantly from the score after nailing at 12 months (11.7 points [95% confidence interval (CI), 7.6 to 15.7 points]) for plating and 11.2 points [95% CI, 8.3 to 14.0 points] for nailing). The Constant-Murley score and shoulder abduction, flexion, external rotation, and internal rotation displayed a significant treatment effect (p treatment ≤ 0.001), in favor of plating. The plating group had 2 implant-related complications, whereas the nailing group had 24, including 13 nail protrusions and 8 screw protrusions. Plating resulted in more postoperative temporary radial nerve palsy (8 patients [10.5%] compared with 1 patient [0.6%]; p < 0.001) and a trend toward fewer nonunions (3 patients [5.7%] compared with 16 patients [11.9%]; p = 0.285) than nailing., Conclusions: Plating of a humeral shaft fracture in adults results in faster recovery, especially of shoulder function. Plating was associated with more temporary nerve palsies, but fewer implant-related complications and surgical reinterventions, than nailing. Despite heterogeneity in implants and surgical approach, plating seems to be the preferred treatment option for these fractures., Level of Evidence: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence., Competing Interests: Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article ( http://links.lww.com/JBJS/H554 )., (Copyright © 2023 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved.)
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- 2023
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6. Publisher Correction: Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER).
- Author
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Van Bergen SH, Van Lieshout EMM, Mahabier KC, Geraerds AJLM, Polinder S, Den Hartog D, and Verhofstad MHJ
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- 2023
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7. Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER).
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Van Bergen SH, Van Lieshout EMM, Mahabier KC, Geraerds AJLM, Polinder S, Den Hartog D, and Verhofstad MHJ
- Subjects
- Adult, Humans, Cost-Benefit Analysis, Prospective Studies, Humerus, Quality of Life, Humeral Fractures surgery
- Abstract
Purpose: Operative treatment of a humeral shaft fracture results in faster recovery than nonoperative treatment. The cost-effectiveness, in terms of costs per Quality-Adjusted Life Year (QALY) gained (Dutch threshold €20,000-€80,000) or minimal important change (MIC) in disability reduced (DASH 6.7), is unknown. The aim of this study was to determine cost-utility and cost-effectiveness of operative versus nonoperative treatment in adults with a humeral shaft fracture type 12A or 12B., Methods: This study was performed alongside a multicenter prospective cohort study. Costs for health care and lost productivity until one year after trauma were calculated. The incremental cost-utility ratio (ICUR) was reported in costs per QALY (based on the EuroQoL-5D-3L (EQ-5D)) gained. The incremental cost-effectiveness ratio (ICER) was reported in costs per MIC (based on the DASH score at three months) reduced., Results: Overall, 245 patients were treated operatively and 145 nonoperatively. In the operative group, the mean total costs per patient (€11,925 versus €8793; p < 0.001) and QALYs (0.806 versus 0.778; p < 0.001) were higher. The ICUR of operative treatment was €111,860 per QALY gained (i.e., €3132/0.028). The DASH was 7.3 points (p < 0.001) lower in the operative group. The ICER of operative treatment was €2880 per MIC in disability reduced (i.e., €3132/7.3*6.7)., Conclusion: Due to the limited effect of treatment on quality of life measured with the EQ-5D, the ICUR of operative treatment (€111,860 per QALY gained) exceeds the threshold. However, the incremental costs of €2880 per clinically meaningful difference in DASH are much lower and suggest that operative treatment for a humeral shaft fracture is cost-effective., (© 2022. The Author(s).)
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- 2023
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8. Functional and clinical outcome after operative versus nonoperative treatment of a humeral shaft fracture (HUMMER): results of a multicenter prospective cohort study.
- Author
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Den Hartog D, Van Bergen SH, Mahabier KC, Verhofstad MHJ, and Van Lieshout EMM
- Subjects
- Adult, Female, Fracture Fixation, Internal methods, Humans, Humerus, Prospective Studies, Treatment Outcome, Humeral Fractures surgery, Quality of Life
- Abstract
Purpose: The best treatment of humeral shaft fractures in adults is still under debate. This study aimed to compare functional and clinical outcome of operative versus nonoperative treatment in adult patients with a humeral shaft fracture. We hypothesized that operative treatment would result in earlier functional recovery., Methods: From October 23, 2012 to October 03, 2018, adults with a humeral shaft fracture AO type 12A or 12B were enrolled in a prospective cohort study in 29 hospitals. Patients were treated operatively or nonoperatively. Outcome measures were the Disabilities of the Arm, Shoulder, and Hand score (DASH; primary outcome), Constant-Murley score, pain (Visual Analog Score, VAS), health-related quality of life (Short Form-36 (SF-36) and EuroQoL-5D-3L (EQ-5D)), activity resumption (Numeric Rating Scale, NRS), range of motion (ROM) of the shoulder and elbow joint, radiologic healing, and complications. Patients were followed for one year. Repeated measure analysis was done with correction for age, gender, and fracture type., Results: Of the 390 included patients, 245 underwent osteosynthesis and 145 were primarily treated nonoperatively. Patients in the operative group were younger (median 53 versus 62 years; p < 0.001) and less frequently female (54.3% versus 64.8%; p = 0.044). Superior results in favor of the operative group were noted until six months follow-up for the DASH, Constant-Murley, abduction, anteflexion, and external rotation of the shoulder, and flexion and extension of the elbow. The EQ-US, and pronation and supination showed superior results for the operative group until six weeks follow-up. Malalignment occurred only in the nonoperative group (N = 14; 9.7%). In 19 patients with implant-related complications (N = 26; 10.6%) the implant was exchanged or removed. Nonunion occurred more often in the nonoperative group (26.3% versus 10.10% in the operative group; p < 0.001)., Conclusion: Primary osteosynthesis of a humeral shaft fracture (AO type 12A and 12B) in adults is safe and superior to nonoperative treatment, and should therefore be the treatment of choice. It is associated with a more than twofold reduced risk of nonunion, earlier functional recovery and a better range of motion of the shoulder and elbow joint than nonoperative treatment. Even after including the implant-related complications, the overall rate of complications as well as secondary surgical interventions was highest in the nonoperative group., Trial Registration: NTR3617 (registration date 18-SEP-2012)., (© 2022. The Author(s).)
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- 2022
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9. Rasch analysis of the Disabilities of the Arm, Shoulder and Hand (DASH) instrument in patients with a humeral shaft fracture.
- Author
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Van Lieshout EMM, Mahabier KC, Tuinebreijer WE, Verhofstad MHJ, and Den Hartog D
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- Adult, Aged, Diaphyses injuries, Female, Humans, Language, Male, Middle Aged, Netherlands, Prospective Studies, Psychometrics, Reproducibility of Results, Disability Evaluation, Humeral Fractures physiopathology, Surveys and Questionnaires
- Abstract
Background: The Disabilities of the Arm, Shoulder and Hand (DASH) instrument was developed to assess the disability experienced by patients with any musculoskeletal condition of the upper extremity and to monitor change in symptoms and upper-limb function over time. The 30 items are scored on a 5-point rating scale. The Dutch-language version of the DASH instrument (DASH-DLV) has been examined with the classical test theory in patients with a humeral shaft fracture. This study aimed to examine the DASH-DLV with a more rigorous and extensive analysis by applying the Rasch model., Methods: Data of 400 patients included in a multicenter, prospective study comparing operative and nonoperative treatment of adult patients with a humeral shaft fracture were used. The person-item map, item fit statistics, reliability, response category ordering, and dimensionality were examined. Raw data were converted to linear measures using the Rasch model., Results: The DASH-DLV showed a good fit to the Rasch model, except for item 26 ("Tingling [pins and needles] in your arm, shoulder or hand"). The person reliability was 0.92. In general, the category functioning of the 5-point rating scale was working well. Dimensionality analysis revealed that the DASH-DLV is a unidimensional scale. Differential item functioning for sex was not detected, and only item 26 exhibited differential item functioning as a function for age., Conclusion: The DASH-DLV fits the stringent Rasch model in a clinical situation with a group of adult patients with a humeral shaft fracture. Adequate measurement for scientific research can be obtained to evaluate longitudinal intervention research., (Copyright © 2019 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)
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- 2020
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10. Reliability and Reproducibility of the OTA/AO Classification for Humeral Shaft Fractures.
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Mahabier KC, Van Lieshout EM, Van Der Schaaf BC, Roukema GR, Punt BJ, Verhofstad MH, and Den Hartog D
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- Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Netherlands, Observer Variation, Orthopedics methods, Reproducibility of Results, Sensitivity and Specificity, Traumatology methods, Young Adult, Humeral Fractures classification, Humeral Fractures diagnostic imaging, Orthopedics standards, Trauma Severity Indices, Traumatology standards
- Abstract
Objectives: This study aimed to determine interobserver reliability and intraobserver reproducibility of the OTA/AO classification for humeral shaft fractures, and to evaluate differences between fracture types, fracture groups, and surgical specializations., Methods: Thirty observers (25 orthopaedic trauma surgeons and 5 general orthopaedic surgeons) independently classified 90 humeral shaft fractures according to the OTA/AO classification. Patients of 16 years and older were included. Periprosthetic, recurrent, and pathological fractures were excluded. Radiographs were provided in random order, and observers were blinded to clinical information. To determine intraobserver agreement, radiographs were reviewed again after 2 months in a different random order. Agreement was assessed using kappa statistics., Results: Interobserver agreement for the 3 fracture types was moderate (κ = 0.60; 0.59-0.61). It was substantial for type A (κ = 0.77; 0.70-0.84) and moderate for type B (κ = 0.52; 0.46-0.58) and type C fractures (κ = 0.46; 0.42-0.50). Interobserver agreement for the 9 fracture groups was moderate (κ = 0.48; 95% CI, 0.48-0.48). Orthopaedic trauma surgeons had better overall agreement for fracture types, and general orthopaedic surgeons had better overall agreement for fracture groups. Observers classified 64% of fractures identically in both rounds. Intraobserver agreement was substantial for the 3 types (κ = 0.80; 0.77-0.81) and 9 groups (κ = 0.80; 0.77-0.82). Intraobserver agreement showed no differences between surgical disciplines., Conclusions: The OTA/AO classification for humeral shaft fractures has a moderate interobserver and substantial intraobserver agreement for fracture types and groups.
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- 2017
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11. Reliability, validity, responsiveness, and minimal important change of the Disabilities of the Arm, Shoulder and Hand and Constant-Murley scores in patients with a humeral shaft fracture.
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Mahabier KC, Den Hartog D, Theyskens N, Verhofstad MHJ, and Van Lieshout EMM
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- Adult, Cohort Studies, Female, Humans, Humeral Fractures complications, Male, Middle Aged, Netherlands, Outcome Assessment, Health Care, Recovery of Function, Reproducibility of Results, Surveys and Questionnaires, Upper Extremity physiopathology, Disability Evaluation, Humeral Fractures physiopathology, Humeral Fractures therapy
- Abstract
Background: The Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley scores are commonly used instruments. The DASH is patient-reported, and the Constant-Murley combines a clinician-reported and a patient-reported part. For patients with a humeral shaft fracture, their validity, reliability, responsiveness, and minimal important change (MIC) have not been published. This study evaluated the measurement properties of these instruments in patients who sustained a humeral shaft fracture., Methods: The DASH and Constant-Murley instruments were completed 5 times until 1 year after trauma. Pain score, Short Form 36, and EuroQol-5D were completed for comparison. Internal consistency was determined by the Cronbach α. Construct and longitudinal validity were evaluated by assessing hypotheses about expected Spearman rank correlations in scores and change scores, respectively, between patient-reported outcome measures (sub)scales. The smallest detectable change (SDC) was calculated. The MIC was determined using an anchor-based approach. The presence of floor and ceiling effects was determined., Results: A total of 140 patients were included. Internal consistency was sufficient for DASH (Cronbach α = 0.96) but was insufficient for Constant-Murley (α = 0.61). Construct and longitudinal validity were sufficient for both patient-reported outcome measures (>75% of correlations hypothesized correctly). The MIC and SDC were 6.7 (95% confidence interval, 5.0-15.8) and 19.0 (standard error of measurement, 6.9), respectively, for DASH and 6.1 (95% CI -6.8 to 17.4) and 17.7 (standard error of measurement, 6.4), respectively, for Constant-Murley., Conclusions: The DASH and Constant-Murley are valid instruments for evaluating outcome in patients with a humeral shaft fracture. Reliability was only shown for the DASH, making this the preferred instrument. The observed MIC and SDC values provide a basis for sample size calculations for future research., (Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)
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- 2017
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12. The reliability and reproducibility of the Hertel classification for comminuted proximal humeral fractures compared with the Neer classification.
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Iordens GI, Mahabier KC, Buisman FE, Schep NW, Muradin GS, Beenen LF, Patka P, Van Lieshout EM, and Den Hartog D
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- Cohort Studies, Female, Fractures, Comminuted diagnostic imaging, Humans, Injury Severity Score, Male, Observer Variation, Orthopedics classification, Radiography methods, Reproducibility of Results, Shoulder Fractures diagnostic imaging, Fractures, Comminuted classification, Imaging, Three-Dimensional, Shoulder Fractures classification, Tomography, X-Ray Computed methods
- Abstract
Introduction: The Neer classification is the most commonly used fracture classification system for proximal humeral fractures. Inter- and intra-observer agreement is limited, especially for comminuted fractures. A possibly more straightforward and reliable classification system is the Hertel classification. The aim of this study was to compare the inter- and intra-observer variability of the Hertel with the Neer classification in comminuted proximal humeral fractures., Materials and Methods: Four observers evaluated blinded radiographic images (X-rays, CT-scans, and CT-scans with 3D-reconstructions) of 60 patients. After at least two months classification was repeated., Results: Inter-observer agreement on plain X-rays was fair for both Hertel (κ = 0.39; 95% CI 0.23-0.62) and Neer (κ = 0.29; 0.09-0.42). Inter-observer agreement on CT-scans was substantial (κ = 0.63; 0.56-0.72) for Hertel and moderate for Neer (κ = 0.51; 0.29-0.68). Inter-observer agreement on 3D-reconstructions was moderate for both Hertel (κ = 0.60; 0.53-0.72) and Neer (κ = 0.51; 0.39-0.58). Intra-observer agreement on plain X-rays was fair for both Hertel (κ = 0.38; 0.27-0.59) and Neer (κ = 0.40; 0.15-0.52). Intra-observer agreement on CT-scans was moderate for both Hertel (κ = 0.50; 0.38-0.66) and Neer (κ = 0.42; 0.35-0.52). Intra-observer agreement on 3D-reconstructions was moderate for Hertel (κ = 0.55; 0.45-0.64) and substantial for Neer (κ = 0.63; 0.48-0.79)., Conclusions: The Hertel and Neer classifications showed a fair to substantial inter- and intra-observer agreement on the three diagnostic modalities used. Although inter-observer agreement was highest for Hertel classification on CT-scans, Neer classification had the highest intra-observer agreement on 3D-reconstructions. Data of this study do not confirm superiority of either classification system for the classification of comminuted proximal humeral fractures., (Copyright © 2016 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.)
- Published
- 2016
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13. Trends in incidence rate, health care consumption, and costs for patients admitted with a humeral fracture in The Netherlands between 1986 and 2012.
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Mahabier KC, Hartog DD, Van Veldhuizen J, Panneman MJ, Polinder S, Verhofstad MH, and Van Lieshout EM
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- Age Distribution, Age Factors, Emergency Service, Hospital statistics & numerical data, Female, Health Care Costs, Health Resources economics, Hospital Costs, Hospitalization statistics & numerical data, Humans, Humeral Fractures epidemiology, Humeral Fractures therapy, Incidence, Length of Stay economics, Male, Netherlands epidemiology, Physical Therapy Modalities economics, Retrospective Studies, Sex Distribution, Sex Factors, Time Factors, Treatment Outcome, Emergency Service, Hospital economics, Health Resources statistics & numerical data, Hospitalization economics, Humeral Fractures economics
- Abstract
Introduction: This study aimed to examine long-term population-based trends in the incidence rate of patients with a humeral fracture admitted to a hospital in the Netherlands from 1986 to 2012 and to give a detailed overview of the health care consumption and productivity loss with associated costs., Materials and Methods: Age and gender-standardised incidence rates of hospital admissions for patients with a proximal, shaft, or distal humeral fracture were calculated for each year (1986-2012). Injury cases, length of hospital stay (LOS), trauma mechanism, and operation rate were extracted from the National Medical Registration. An incidence-based cost model was applied to calculate costs for direct health care and lost productivity in 2012., Results: Between 1986 and 2012 112,910 patients were admitted for a humeral fracture. The incidence rate increased from 17.8 in 1986 to 40.0 per 100,000 person years in 2012. Incidence rates of proximal fractures increased the most, especially in elderly women. Operation rates decreased in patients aged 70 years or older. The mean LOS decreased from nine days in 1997 to five days in 2012. The cumulative LOS of all patients in 2012 was 28,880 days of which 73% were caused by women and 81% were caused by patients aged 50 years or older. Cumulative medical costs in 2012 were M€55.4, of which M€43.4 was spent on women. Costs increased with age. Costs for hospital care contributed most to the overall costs per case until 70 years of age. From 70 years onwards, the main cost determinants were hospital care, rehabilitation/nursing care, and home care. Cumulative costs due to lost productivity were M€23.5 in 2012. Costs per case increased with age in all anatomic regions., Conclusions: The crude number of patients admitted for a humeral fracture increased 124% in 27 years, and was associated with age and gender. Proximal fractures in elderly women accounted most significantly for this increase and most of the costs. The main cost determinants were hospital care and productivity loss., (Copyright © 2015 Elsevier Ltd. All rights reserved.)
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- 2015
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14. HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.
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Mahabier KC, Van Lieshout EM, Bolhuis HW, Bos PK, Bronkhorst MW, Bruijninckx MM, De Haan J, Deenik AR, Dwars BJ, Eversdijk MG, Goslings JC, Haverlag R, Heetveld MJ, Kerver AJ, Kolkman KA, Leenhouts PA, Meylaerts SA, Onstenk R, Poeze M, Poolman RW, Punt BJ, Roerdink WH, Roukema GR, Sintenie JB, Soesman NM, Tanka AK, Ten Holder EJ, Van der Elst M, Van der Heijden FH, Van der Linden FM, Van der Zwaal P, Van Dijk JP, Van Jonbergen HP, Verleisdonk EJ, Vroemen JP, Waleboer M, Wittich P, Zuidema WP, Polinder S, Verhofstad MH, and Den Hartog D
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- Activities of Daily Living, Clinical Protocols, Cost-Benefit Analysis, Disability Evaluation, Fracture Fixation economics, Health Care Costs, Humans, Humeral Fractures diagnosis, Humeral Fractures economics, Humeral Fractures physiopathology, Humeral Fractures surgery, Netherlands, Pain Measurement, Prospective Studies, Recovery of Function, Return to Work, Surveys and Questionnaires, Time Factors, Treatment Outcome, Fracture Fixation methods, Fracture Healing, Humeral Fractures therapy, Research Design
- Abstract
Background: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery., Methods/design: The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective., Discussion: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture., Trial Registration: The trial is registered at the Netherlands Trial Register (NTR3617).
- Published
- 2014
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15. Humeral shaft fractures: retrospective results of non-operative and operative treatment of 186 patients.
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Mahabier KC, Vogels LM, Punt BJ, Roukema GR, Patka P, and Van Lieshout EM
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- Female, Fracture Healing, Fractures, Ununited rehabilitation, Fractures, Ununited therapy, Humans, Humeral Fractures rehabilitation, Humeral Fractures surgery, Male, Middle Aged, Netherlands epidemiology, Patient Satisfaction, Range of Motion, Articular, Retrospective Studies, Treatment Outcome, Accidental Falls statistics & numerical data, Fracture Fixation, Internal methods, Fracture Fixation, Intramedullary methods, Fractures, Ununited epidemiology, Humeral Fractures epidemiology, Humeral Fractures therapy
- Abstract
Background: Humeral shaft fractures account for 1-3% of all fractures and 20% of the fractures involving the humerus. The aim of the current study was to compare the outcome after operative and non-operative treatment of humeral shaft fractures, by comparing the time to radiological union and the rates of delayed union and complications., Methods: All patients aged 16 years or over treated for a humeral shaft fracture during a 5-year period were included in this retrospective analysis; periprosthetic and pathological fractures were excluded. Radiographs and medical charts were retrieved and reviewed in order to collect data on fracture classification, time to radiographic consolidation and the occurrence of adverse events., Results: A total of 186 patients were included; 91 were treated non-operatively and 95 were treated operatively. Mean age was 58.7 ± 1.5 years and 57.0% were female. In 83.3% of the patients, only the humerus was affected. A fall from standing height was the most common cause of the fracture (72.0%). Consolidation time varied from a median of 11-28 weeks. The rate of radial nerve palsy in both groups was similar: 8.8% versus 9.5%. In 5.3% of the operatively treated patients, the palsy resulted from the operation. Likewise, delayed union rates were similar in both groups: 18.7% following non-operative treatment versus 18.9% following surgery., Conclusion: The data indicated that consolidation time and complication rates were similar after operative and non-operative treatment. A prospective randomised clinical trial comparing non-operative with operative treatment is needed in order to examine other aspects of outcome, meaning shoulder and elbow function, postoperative infection rates, trauma-related quality of life and patient satisfaction., (Copyright © 2012 Elsevier Ltd. All rights reserved.)
- Published
- 2013
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