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Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort.

ABSTRACT: INTRODUCTION:Humeral shaft fractures represent 1%-3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment. METHODS AND ANALYSIS:We will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and conservative treatment of humeral shaft fractures. After providing informed consent, 80 patients from 18 years of age with humeral shaft fracture will be randomly assigned to open reduction and internal fixation with locking plate or conservative treatment with functional bracing. We will follow the patients for 10 years and compare the results at different time points. The primary outcome will be Disabilities of Arm, Shoulder and Hand (DASH) at 12 months. The secondary outcomes will include Numerical Rating Scale for pain at rest and in activities, Constant Score and quality of life instrument 15D. Patients not willing to participate in the RCT will be asked to participate in a prospective cohort follow-up study, 'the declined cohort'. This cohort will be followed up at the same time points as the randomised patients to assess the potential effect of participation bias on RCT results and to enhance the external validity of the RCT. In one of the recruiting centres, all cooperative patients with humeral shaft fractures not eligible for randomisation will be asked to participate in a 'non-eligible cohort' study. We will use blinded data interpretation of the randomised cohort to avoid biased interpretation of outcomes. Our null hypothesis is that there is no clinically relevant difference in the primary outcome measure between the two treatment groups. We will consider a difference of a minimum of 10 points in DASH clinically relevant. ETHICS AND DISSEMINATION:The institutional review board of the Helsinki and Uusimaa Hospital District has approved the protocol. We will disseminate the findings of this study through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT01719887; pre-results.

SUBMITTER: Ramo L

PROVIDER: S-EPMC5734401 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort.

Rämö Lasse L Taimela Simo S Lepola Vesa V Malmivaara Antti A Lähdeoja Tuomas T Paavola Mika M

BMJ open 20170709 7

<h4>Introduction</h4>Humeral shaft fractures represent 1%-3% of all fractures and 20% of humeral fractures in adults. The treatment of these fractures is mainly conservative and operative treatment is usually reserved for specific circumstances. To date, no randomised controlled trial (RCT) has compared operative treatment of humeral shaft fractures with conservative treatment.<h4>Methods and analysis</h4>We will conduct an RCT to compare the effectiveness and cost-effectiveness of surgical and ...[more]

PMID: 28694341

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Project description:BackgroundLateral humeral condyle fractures are the second most common elbow fracture in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used in the fixation of these fractures. Here, we introduce a new fixation method that uses an absorbable screw. We aim to determine if it is feasible to treat lateral humeral condyle fractures with an absorbable screw by comparing functional outcomes following absorbable screw fixation vs. K-wire fixation.MethodsBetween May 2007 and September 2010, 86 patients were treated with absorbable screws (43 patients) or K-wire (43 patients). All patients had been diagnosed with lateral condyle fractures that were classified as either Jacob type II (unstable) or III. One absorbable screw (3.5 mm-diameter) was used for fixation in 1 group, while two 1.6 to 1.8 mm K-wires were used in the other group. Patients were followed 6 months about the elbow function according to Broberg and Morrey standard. On 5-7 years, the patients were followed about the carrying angle (valgus deformities and varus deformities), range of motion (flexion loss and extension loss), prominent lateral condyle, symptomatic implants, and fishtail deformity.ResultsAnatomic reduction was achieved in all patients. Each group had one radial nerve injury that were present preoperatively. Nerve function recovered spontaneously within 3 to 4 weeks of surgery in both patients. No patient developed necrosis of the capitulum in both groups. Nine patients in K-wires group and 2 in absorbable screw group developed symptomatic implants (P = .048). On the sixth month, there was no significant difference on elbow function according to Broberg and Morrey standard. On 5 to 7 years (average, 6.7 ± 1.3 years), valgus deformities was 6.8 ± 1.2 vs 5.7 ± 0.8, varus deformities was 7.2 ± 1.5 vs 5.1 ± 1.9, flexion loss was 12.4 ± 2.2 vs 9.5 ± 3.1, extension loss was 11.1 ± 3.1 vs 10.2 ± 2.7, prominent lateral condyle was 27.9% vs 37.2%, fishtail deformity was 7.3% vs 4.9%, no significant difference between these groups.ConclusionsOpen reduction with absorbable screw fixation is feasible and safe for the treatment of lateral condyle fractures of the humerus in children.Level of evidenceTherapeutic III.

Project description:BackgroundOpen reduction internal fixation (ORIF) has long been the conventional procedure for managing displaced patella fracture. This surgical approach has certain drawbacks, which might affect clinical outcomes and patient prognosis. Minimally invasive percutaneous fixation (MIPF) was proposed to overcome these disadvantages. Few in-depth investigations have been performed to determine the superiority of MIPF over ORIF. The aim of this study was to compare the efficacies of MIPF and ORIF for patella fractures.MethodsThe PubMed, Cochrane Library, Embase, and Scopus databases were searched for relevant studies from November 26 to December 17, 2020. Non-English publications and pediatric orthopedic articles were excluded. Statistical analysis was performed using Review Manager, version 5.4, with mean differences (MDs), standardized mean differences (SMDs), odds ratios (ORs), and respective 95% confidence intervals (CIs) calculated using a random effects model. The primary outcomes were the pain score, knee range of motion, and joint functionality. The secondary outcomes were the surgical time, complications, and implant removal rate.ResultsSix articles with a total of 304 patients were included in the meta-analysis. Pooled analysis revealed that patients with MIPF had a significantly reduced pain score (MD = - 1.30, 95% CI = - 1.77 to -0.82; p < 0.00001) and increased knee extension angles (MD = 0.72, 95% CI = 0.18 to 1.25; p = 0.009) at 3-month follow-up. Furthermore, knee flexion angles (MD = 8.96, 95% CI = 5.81 to 12.1; p < 0.00001) and joint functionality (SMD = 0.54, 95% CI = 0.21 to 0.86; p = 0.001) had statistically improved at 2 years. However, no difference was observed between MIPF and ORIF with regard to the surgical time. The risk of complications (OR = 0.10, 95% CI = 0.05 to 0.18; p < 0.00001) and implant removal rate (OR = 0.20, 95% CI = 0.07 to 0.57; p = 0.003) were significantly lower with MIPF than with ORIF.ConclusionsMIPF is more favorable than ORIF in terms of the pain score, knee range of motion, joint functionality, complications, and implant removal rate. Thus, it can be adopted as an alternative to ORIF.

Dataset Information

Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort.

Publications

Open reduction and internal fixation of humeral shaft fractures versus conservative treatment with a functional brace: a study protocol of a randomised controlled trial embedded in a cohort.

Similar Datasets

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