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Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.

ABSTRACT: Importance:Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend. Objective:To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures. Design, Setting, and Participants:Randomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma. Interventions:Patients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n?=?38) or to nonsurgical treatment with functional bracing (n?=?44). Main Outcome and Measure:The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points). Results:Among 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P?=?.34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy. Conclusions and Relevance:Among patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results. Trial Registration:ClinicalTrials.gov Identifier: NCT01719887.

SUBMITTER: Ramo L

PROVIDER: S-EPMC7218498 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.

Rämö Lasse L Sumrein Bakir O BO Lepola Vesa V Lähdeoja Tuomas T Ranstam Jonas J Paavola Mika M Järvinen Teppo T Taimela Simo S

JAMA 20200501 18

<h4>Importance</h4>Humeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.<h4>Objective</h4>To compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.<h4>Design, setting, and participants</h4>Randomized clini ...[more]

PMID: 32396179

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Project description:Existing evidence indicates that surgery fails to provide superior functional outcome over nonoperative care in patients with a closed humeral shaft fracture. However, up to one-third of patients treated nonoperatively may require secondary surgery. To compare the 2-year outcomes of patients who required secondary surgery with the outcomes of patients with successful initial treatment. This 2-year follow-up of the Finnish Shaft of the Humerus (FISH) randomized clinical trial comparing surgery with nonoperative treatment (functional brace) was completed in January 2020. Enrollment in the original trial was between November 2012 and January 2018 at 2 university hospital trauma centers in Finland. A total of 321 adult patients with closed, displaced humeral shaft fracture were assessed for eligibility. After excluding patients with cognitive disabilities, multimorbidity, or multiple trauma and those refusing randomization, 82 patients were randomized. Interventions were surgery with plate fixation (n = 38; initial surgery group) or functional bracing (n = 44); the latter group was divided into the successful fracture healing group (n = 30; bracing group) and the secondary surgery group (n = 14) with fracture healing problems. The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 2 years (range, 0 to 100 points; 0 denotes no disability, 100 extreme disability; minimal clinically important difference, 10 points). Of 82 randomized patients, 38 (46%) were female. The mean (SD) age was 48.9 (17.1) years. A total of 74 patients (90%) completed the 2-year follow-up. At 2 years, the mean DASH score was 6.8 (95% CI, 2.3 to 11.4) in the initial surgery group, 6.0 (95% CI, 1.0 to 11.0) in the bracing group, and 17.5 (95% CI, 10.5 to 24.5) in the secondary surgery group. The between-group difference was -10.7 points (95% CI, -19.1 to -2.3; P = .01) between the initial and secondary surgery groups and -11.5 points (95% CI, -20.1 to -2.9; P = .009) between the bracing group and secondary surgery group. Patients contemplating treatment for closed humeral shaft fracture should be informed that two-thirds of patients treated with functional bracing may heal successfully while one-third may experience fracture healing problems that require secondary surgery and lead to inferior functional outcomes 2 years after the injury. ClinicalTrials.gov Identifier: NCT01719887.

Project description:BackgroundTwo common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well.MethodsWe recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale.ResultsThe change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively.ConclusionOur study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture.Trial registrationClinicalTrials.gov NCT01719887, first registration 01/11/2012.

Project description:ObjectivesThis study was performed to determine (1) the incidence of humeral shaft fractures within the Medicare noncancer population, (2) the trends in utilization of humeral shaft fixation techniques by plate-and-screw devices and intramedullary nails, (3) differences in procedure times, and (4) the outcomes of individuals as measured by rate of secondary operations and 1-year mortality.Design/settingRetrospective comparative cohort analysis. A cancer-free Medicare part B claims sample derived from a 5% sample from the years 1993 to 2007 was analyzed.Patients/interventionOur cohorts were generated by diagnostic and procedural codes for humeral shaft fractures.Main outcome measurementThe incidence of humeral shaft fracture and trend in operative fixation were evaluated for all years of data. Surgical times were assessed by anesthesia Current Procedural Terminology codes. Outcomes and complications were assessed by Current Procedural Terminology codes. The proportion of individuals experiencing complications and 1-year mortality were compared by proportion hazards.ResultsWe identified 1385 claims for humeral shaft fractures over 15 years, with an adjusted rate of between 12.0 and 23.4 fractures per 100,000 beneficiaries. We identified 511 individuals who received surgical treatment for humeral shaft fractures, 451 of whom had complete 1-year follow-up data. Nail fixation was more prevalent than plate fixation most years and had shorter anesthesia time by 27.1 minutes (P < 0.0001). There were no significant differences in the complication rates between the 2 groups as measured by incidence of secondary operations and 1-year mortality.ConclusionsIntramedullary nails are used for the majority of operative humeral shaft fractures among Medicare beneficiaries. Nailing has a shorter mean operative time. The 2 surgical techniques had no significant differences in terms of risk of secondary procedures and 1-year mortality.Level of evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Project description:IntroductionOpen reduction and internal fixation (ORIF) of displaced midshaft clavicle fractures is associated with higher union rates and earlier functional recovery. However, ORIF with plate fixation is associated with complications including implant irritation and implant failure. Dual plate fixation provides fixation in orthogonal planes, and uses a lower profile fixation technique in comparison to pre-contoured and surgeon-contoured small-fragment locking plates, which may be more prominent. The objective of this study was to conduct a systematic review to summarize outcomes and complications associated with surgical fixation of displaced acute midshaft clavicle fractures with dual plate fixation.MethodsUsing a predetermined study protocol in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, the databases MEDLINE, EMBASE, and CENTRAL were searched from inception to 2020 to identify studies reporting outcomes in acute midshaft clavicle fractures treated with dual plate fixation. All clinical studies which reported on outcomes of dual plating in patients with acute midshaft clavicle fractures were included. Baseline demographics, plate fixation constructs, fracture union rates, implant removal rates, maintenance of reduction, symptomatic implant rates, wound complications, and functional outcomes were extracted. All extracted data were recorded, and descriptive statistics were summarized. Meta-analysis was performed on fracture union rates and implant removal rates using random-effects modeling using Mantel-Haenszel weighting.ResultsOur literature search identified 2226 unique abstracts, of which eight studies met our study inclusion criteria following review. A total of 278 patients made up of 79.8% male with an average age of 36.0 years were included. The overall dual plate implant removal rate was 4.2% with excellent rates of union reported. Moreover, single plate fixation was associated with a 3.9-fold increased implant removal rate compared to dual plate fixation.ConclusionResults from this systematic review demonstrate that ORIF of displaced midshaft clavicle fractures using a dual plate fixation technique is a viable option to reduce the incidence of implant removal, without negatively impacting the rate of fracture union.Level of evidenceTherapeutic Level III.

Dataset Information

Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.

Publications

Effect of Surgery vs Functional Bracing on Functional Outcome Among Patients With Closed Displaced Humeral Shaft Fractures: The FISH Randomized Clinical Trial.

Similar Datasets

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