Dataset Information

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

ABSTRACT:

Background

The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.

Methods/design

In a prospective multicentre clinical cohort study at least 200 patients with a healed fracture after osteosynthesis with a metal implant are included for analyzing the outcome after removal. Six hospitals in the Netherlands are participating. Special questionnaires are designed. The follow up after surgery will be at least six months. The primary endpoint is the incidence of surgery related complications. Secondary endpoints are the influence of removal on preoperative symptoms and complaints and the socio-economic consequences.

Discussion

By performing this study we hope to find profound arguments to remove or not to remove metal implants after fracture healing that can help to develop clear guidelines for daily practice.

Trial registration

NTR1297, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1297.

SUBMITTER: Vos DI

PROVIDER: S-EPMC3493388 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

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Publications

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

Vos Dagmar I DI Verhofstad Michael H J MH Hanson Beate B van der Graaf Yolanda Y van der Werken Chris C

BMC musculoskeletal disorders 20120815

<h4>Background</h4>The clinical results of removal of metal implants after fracture healing are unknown and the question whether to remove or to leave them in is part of discussion worldwide. We present the design of a prospective clinical multicentre cohort study to determine the main indications for and expectations of implant removal, the influence on complaints, the incidence of surgery related complications and the socio-economic consequences of implant removal.<h4>Methods/design</h4>In a p ...[more]

PMID: 22894749

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Project description:BackgroundElective implant removal (IR) accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons such as patients' wish for IR. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures.Patients and methodsProspective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included pain rating on a visual analogue scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included Constant-Murley Score, DASH (Disabilities of Arm, Shoulder and Hand Score), MSQ (Munich Shoulder Questionnaire) and SPADI (Shoulder Pain and Disability Index).Results37 patients were prospectively enrolled in this study and implant removal was performed after 16 ± 6.1 months. No re-fractures nor other complications were detected during routine follow up. Functional outcome increased through all scores (Constant score 73.3 ± 14.6 preoperative to 87.4 ± 12.0 postoperative (p = 0.000), MSQ 85.0 ± 7.3 preoperative to 91.8 ± 9.0 postoperative (p = 0.005), DASH Score 7.4 ± 8.2 preoperative to 5.7 ± 9.5 postoperative (p = 0.414), SPADI 93.4 ± 6.6 preoperative to 94.0 ± 10.1 postoperative (p = 0.734).ConclusionsDiscomfort during daily activities or performing sports as well as limited range of motion were the main reasons for patients' wish for implant removal. We found increased functional outcome parameters and decreased irritation after implant removal. Therefore we suggest implant removal in case of patients' wish and completed fracture consolidation.Trial registrationTrial registration no: NCT04343118, Retrospective registered: www.clinicaltrials.gov .

Project description:Prognostic determinants in thoracic trauma are of major public health interest. We intended to describe patterns of thoracic trauma, demographic factors, clinical course, and predictors of outcome in selected tertiary care hospitals in Sri Lanka. A multicentre prospective cohort study was conducted in five leading teaching hospitals from June to September 2017. Patients with thoracic trauma were followed up during the hospital stay. A logistic regression analysis was conducted using in-hospital morbidity as the dichotomous outcome variable. One hundred seventy-one patients were included in the study yielding 1450 (median = 8.5) person-days of observation. Of them, 71.9% (n = 123) were males. The mean age was 45.8 ± 17.9 years. Majority (39.2%, n = 67) were recruited from the National Hospital of Sri Lanka. Automobile accidents were the commonest (62.6%, n = 107), followed by falls (26.9%, n = 46), assaults (8.8%, n = 15), and animal attacks (1.8%, n = 3). The ratio of blunt to penetrating trauma was 5.6 : 1. Injury patterns were rib fractures (80.7%, n = 138), haemothorax (44.4%, n = 76), pneumothorax (44.4%, n = 76), lung contusion (22.8%, n = 39), flail segment (15.8%, n = 27), tracheobronchial trauma (7.0%, n = 12), diaphragmatic injury (2.3%, n = 4), vascular injury (2.3%, n = 4), cardiac contusions (1.1%, n = 2), and oesophageal injury (0.6%, n = 1). Ninety nine (57.9%) had extrathoracic injuries. Majority (63.2%, n = 108) underwent operative management including intercostal tube insertion (60.8%, n = 104), wound exploration (6.4%, n = 11), thoracotomy (4.1%, n = 7), rib reconstruction (4.1%, n = 7), and video-assisted thoracoscopic surgery (2.9%, n = 5). Pneumonia (10.5%, n = 8), bronchopleural fistulae (2.3%, n = 4), tracheaoesophageal fistulae (1.8%, n = 3), empyema (1.2%, n = 2), and myocardial infarction (1.2%, n = 2) were the commonest postoperative complications. The mean hospital stay was 15.6 ± 18.0 days. The in-hospital mortality was 11 (6.4%). The binary logistic regression analysis with five predictors (age, gender, mechanism of injury (automobile/fall/assault), type of trauma (blunt/penetrating), and the presence of extrathoracic injuries) was statistically significant to predict in-hospital morbidity (X 2 (6, n = 168) = 13.1; p=0.041), explaining between 7.5% (Cox and Snell R 2) and 14.5% (Nagelkerke R 2) of variance. The automobile accidents (OR: 2.3, 95% CI = 0.2-26.2) and being males (OR: 2.3, 95% CI = 0.6-9.0) were the strongest predictors of morbidity.

Project description:IntroductionGeriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres.MethodsThe primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore.ResultsGFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (-$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (-$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year).ConclusionsThis analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings.Level of evidenceEconomic, level 2.Trial registration numberNCT02297581.

Project description:Background:One third of women experience intimate partner violence (IPV) in their lifetime. Orthopaedic health care professionals are in a good position to identify women experiencing escalating physical violence and act to promote their immediate safety, connect them to IPV resources, and reduce the risk of further harm. However, there have been no studies that explore whether experiencing a musculoskeletal injury can trigger or worsen IPV, and there have been no studies on how experiences of IPV affect orthopaedic outcomes. The primary objective of the PRAISE-2 pilot study is to assess the feasibility of conducting a large cohort study to determine the association between IPV and injury-related complications. The secondary clinical objectives are to preliminarily explore how a history of IPV affects orthopaedic outcomes and how patterns of IPV change over time following an orthopaedic injury. Methods:We will complete a pilot multicentre prospective cohort study of 250 women with musculoskeletal injuries to determine the feasibility of a multinational prospective cohort study that will determine if prior or ongoing IPV affects orthopaedic outcomes following an injury, and how patterns of IPV change over time. Our primary outcome is feasibility measured using recruitment rate (success criterion 50 patients/site in 12 months), adherence to visit windows (success criterion 75%), participant retention (success criterion 85%), and data completeness (success criterion 80%). Our secondary exploratory clinical outcomes are injury-related complications, return to function, new IPV disclosures, utilization and cost of support services, changes in abuse patterns, quality of life, and readiness to make relationship changes. We will assess feasibility based on pre-defined criteria for feasibility success and we will analyze secondary outcomes in an exploratory fashion. Discussion:The PRAISE-2 pilot study is the first step toward determining how experiences of IPV affect orthopaedic outcomes such as injury-related complications. This study will determine feasibility and assist in the development of large-scale multinational prospective IPV studies for our future IPV research program. This study will engage health care professionals from around the world to increase awareness of how IPV affects patients' musculoskeletal and injury outcomes. Trial registration:clinicaltrials.gov NCT02529267. Registered 20 Aug 2015.

Dataset Information

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

Background

Methods/design

Discussion

Trial registration

Publications

Clinical outcome of implant removal after fracture healing. Design of a prospective multicentre clinical cohort study.

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