Dataset Information

Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design.

ABSTRACT:

Background

Tibial shaft fractures (TSFs) are among the most common long bone injuries often resulting from high-energy trauma. To date, musculoskeletal complications such as fracture-related infection (FRI) and compromised fracture healing following fracture fixation of these injuries are still prevalent. The relatively high complication rates prove that, despite advances in modern fracture care, the management of TSFs remains a challenge even in the hands of experienced surgeons. Therefore, the Fracture-Related Outcome Study for operatively treated Tibia shaft fractures (F.R.O.S.T.) aims at creating a registry that enables data mining to gather detailed information to support future clinical decision-making regarding the management of TSF's.

Methods

This prospective, international, multicenter, observational registry for TSFs was recently developed. Recruitment started in 2019 and is planned to take 36?months, seeking to enroll a minimum of 1000 patients. The study protocol does not influence the clinical decision-making procedure, implant choice, or surgical/imaging techniques; these are being performed as per local hospital standard of care. Data collected in this registry include injury specifics, treatment details, clinical outcomes (e.g., FRI), patient-reported outcomes, and procedure- or implant-related adverse events. The minimum follow up is 12?months.

Discussion

Although over the past decades, multiple high-quality studies have addressed individual research questions related to the outcome of TSFs, knowledge gaps remain. The scarcity of data calls for an international high-quality, population-based registry. Creating such a database could optimize strategies intended to prevent severe musculoskeletal complications. The main purpose of the F.R.O.S.T registry is to evaluate the association between different treatment strategies and patient outcomes. It will address not only operative techniques and implant materials but also perioperative preventive measures. For the first time, data concerning systemic perioperative antibiotic prophylaxis, the influence of local antimicrobials, and timing of soft-tissue coverage will be collected at an international level and correlated with standardized outcome measures in a large prospective, multicenter, observational registry for global accessibility.

Trial registration

ClinicalTrials.gov : NCT03598530 .

SUBMITTER: Metsemakers WJ

PROVIDER: S-EPMC7797092 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design.

Metsemakers Willem-Jan WJ Kortram Kirsten K Ferreira Nando N Morgenstern Mario M Joeris Alexander A Pape Hans-Christoph HC Kammerlander Christian C Konda Sanjit S Oh Jong-Keon JK Giannoudis Peter V PV Egol Kenneth A KA Obremskey William T WT Verhofstad Michael H J MHJ Raschke Michael M

BMC musculoskeletal disorders 20210109 1

<h4>Background</h4>Tibial shaft fractures (TSFs) are among the most common long bone injuries often resulting from high-energy trauma. To date, musculoskeletal complications such as fracture-related infection (FRI) and compromised fracture healing following fracture fixation of these injuries are still prevalent. The relatively high complication rates prove that, despite advances in modern fracture care, the management of TSFs remains a challenge even in the hands of experienced surgeons. Theref ...[more]

PMID: 33422025

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Project description:BackgroundTibia shaft fractures (TSF) are common for men and women and cause substantial morbidity, healthcare use, and costs. The impact of nonunions on healthcare use and costs is poorly described. Our goal was to investigate patient characteristics and healthcare use and costs associated with TSF in patients with and without nonunion.MethodsWe retrospectively analyzed medical claims in large U.S. managed care claims databases (Thomson Reuters MarketScan®, 16 million lives). We studied patients ≥ 18 years old with a TSF diagnosis (ICD-9 codes: 823.20, 823.22, 823.30, 823.32) in 2006 with continuous pharmaceutical and medical benefit enrollment 1 year prior and 2 years post-fracture. Nonunion was defined by ICD-9 code 733.82 (after the TSF date).ResultsAmong the 853 patients with TSF, 99 (12%) had nonunion. Patients with nonunion had more comorbidities (30 vs. 21, pre-fracture) and were more likely to have their TSF open (87% vs. 70%) than those without nonunion. Patients with nonunion were more likely to have additional fractures during the 2-year follow-up (of lower limb [88.9% vs. 69.5%, P < 0.001], spine or trunk [16.2% vs. 7.2%, P = 0.002], and skull [5.1% vs. 1.3%, P = 0.008]) than those without nonunion. Nonunion patients were more likely to use various types of surgical care, inpatient care (tibia and non-tibia related: 65% vs. 40%, P < 0.001) and outpatient physical therapy (tibia-related: 60% vs. 42%, P < 0.001) than those without nonunion. All categories of care (except emergency room costs) were more expensive in nonunion patients than in those without nonunion: median total care cost $25,556 vs. $11,686, P < 0.001. Nonunion patients were much more likely to be prescribed pain medications (99% vs. 92%, P = 0.009), especially strong opioids (90% vs. 76.4%, P = 0.002) and had longer length of opioid therapy (5.4 months vs. 2.8 months, P < 0.001) than patients without nonunion. Tibia fracture patterns in men differed from those in women.ConclusionsNonunions in TSF's are associated with substantial healthcare resource use, common use of strong opioids, and high per-patient costs. Open fractures are associated with higher likelihood of nonunion than closed ones. Effective screening of nonunion risk may decrease this morbidity and subsequent healthcare resource use and costs.

Project description:Background: A tibia shaft fracture is one of the most common long bone fractures, with two general types, open fracture and close fracture. However, there is no universally accepted guideline suggesting which treatment to use under certain circumstances. Therefore, a comprehensive network meta-analysis (NMA) is needed to summarize existing studies and to provide more credible data-based medical guidelines. Methods: Available literature was identified by searching medical databases with relevant key terms. Studies that met the inclusion and exclusion criteria, baseline, intervention, and the outcome of treatments, were extracted. A comparative connection of these studies was demonstrated through net plots. Continuous variables and binary variables were reported as mean difference (MD) and odds ratio (OR) with a 95% credible interval (CrI), respectively. The comparison of direct and indirect outcome and their P-value were listed in the node-splitting table. Treatments for each endpoint were ranked by their surface under the cumulative ranking curve (SUCRA) value. A heat plot was created to illustrate the contribution of raw data and the inconsistency between direct and indirect comparisons. Results: According to the search strategy, 697 publications were identified, and 25 records were included, involving 3,032 patients with tibia shaft fractures. Seven common surgical or non-surgical treatments, including reamed intramedullary nailing (RIN), un-reamed intramedullary nailing (UIN), minimally reamed intramedullary nailing (MIN), ender nailing (EN), external fixation (EF), plate, and cast, were compared, in terms of time to union, reoperation, non-union, malunion, infection and implant failure. Plate performed relatively better for time to union, while cast might be the best choice in close cases to reduce the risks of reoperation, non-union, malunion, and infection. To prevent implant failure, EN seemed to be better. Conclusion: Cast might have the highest probability of the most optimal choice for tibia shaft fracture in close cases, while reamed intramedullary nailing ranked second.

Project description:BackgroundClinical management in orthogeriatric units and outcome indicators are similar for extracapsular fragility hip fractures, without discriminating between subtrochanteric and pertrochanteric fractures.HypothesisGeriatric patients, 75 years or older, with subtrochanteric fractures have worse clinical and functional outcomes than those with pertrochanteric fractures.Materials and methodsRetrospective observational study of data prospectively collected by the Spanish Hip Fracture Registry including patients 75 years or older, admitted for extracapsular hip fractures from January 2017 to June 2019. Demographic and baseline status, pre-operative, post-operative and 30-day follow-up data were included.ResultsA total of 13,939 patients with extracapsular hip fractures were registered: 12,199 (87.5%) pertrochanteric and 1740 (12.5%) subtrochanteric. At admission, patients with subtrochanteric fractures were younger (86.5 ± 5.8 versus 87.1 ± 5.6 years old), had better pre-fracture mobility (3.7 ± 2.7 versus 3.9 ± 2.8) (1-to-10 scale, 1 being independent) and were more likely to be living at home; those with pertrochanteric fractures had worse cognitive function (Pfeiffer 3.3 ± 3.3 versus 3.8 ± 3.5). The subtrochanteric fracture group showed worse post-fracture mobility (7.3 ± 2.7 versus 6.7 ± 2.7) and greater deterioration of mobility (3.7 ± 3.0 versus 2.9 ± 2.7). Among individuals living at home at baseline, those with subtrochanteric fractures were more likely to remain in an assisted facility at 30-day follow-up. In-hospital mortality during acute admission was higher for the subtrochanteric group (5.6% versus 4.5%) (p = 0.028). To our knowledge, this is the first paper highlighting the differences between these two fracture groups in the geriatric population.ConclusionsSubtrochanteric fractures in the older population are a different and worse entity, with greater morbimortality and functional decline than pertrochanteric fractures. Despite being younger and fitter at admission, older patients with subtrochanteric fractures have a higher risk of remaining non-weight bearing and undergoing re-operation and institutionalization. Orthogeriatric units should be aware of this and manage subtrochanteric fractures accordingly.Level of evidenceIV.

Dataset Information

Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design.

Background

Methods

Discussion

Trial registration

Publications

Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design.

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