Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial.

BACKGROUND: A key decision in the treatment of atrial fibrillation is choosing between a rhythm control strategy or a rate control strategy as the main strategy. When choosing rate control, the optimal heart rate target is uncertain. The Danish Atrial Fibrillation trial is a randomized, multicenter, two-group, superiority trial comparing strict rate control versus lenient rate control in patients with either persistent or permanent atrial fibrillation at inclusion. To prevent bias arising from selective reporting and data-driven analyses, we developed a predefined description of the statistical analysis. METHODS: The primary outcome of this trial is the physical component score of the SF-36 questionnaire. A total of 350 participants will be enrolled based on a minimal important difference of 3 points on the physical component score of the SF-36 questionnaire, a standard deviation of 10 points, a statistical power of 80% (beta of 20%), and an acceptable risk of type I error of 5%. All secondary, exploratory, and echocardiographic outcomes will be hypothesis-generating. The analyses of all outcomes will be based on the intention-to-treat principle. We will analyze continuous outcomes using linear regression adjusting for "site," type of atrial fibrillation at inclusion (persistent/ permanent), left ventricular ejection fraction (≥ 40% or < 40%), and the baseline value of the outcome (all as fixed effects). We define our threshold for statistical significance as a p-value of 0.05 and assessments of clinical significance will be based on the anticipated intervention effects defined in the sample size and power estimations. Thresholds for both statistical and clinical significance will be assessed according to the 5-step procedure proposed by Jakobsen and colleagues. DISCUSSION: This statistical analysis plan will be published prior to enrolment completion and before any data are available and is sought to increase the validity of the DANish Atrial Fibrillation trial. TRIAL REGISTRATION: Clinicaltrials.gov NCT04542785. Registered on Sept 09, 2020.

Functional outcomes and complications of tibial lengthening using unilateral external fixation and then plating. A prospective case series.

INTRODUCTION: and Importance: The purpose of this study was to assess the functional outcomes and complications of tibial lengthening using unilateral external fixation and then plating. MATERIAL AND METHODS: This was a prospective case series study that enrolled people of short stature or leg length discrepancy of more than 3 cm from January 2019 to January 2021. A total of 11 patients (one male and 10 females) were recruited for the study, including seven short statures and four patients with leg length discrepancies. The external fixaters in this study were Muller's frame or Nhan's frame. RESULTS: The average age of patients at the time of surgery was 25.89 years (range: 13-41 years). The study included 18 tibias that were lengthened and then plated. Average tibial lengthening was 6.89 ± 1.25 cm (21.87 ± 6.59%). The functional result was excellent in seven patients and good in four patients. Pin-track infection occurred in three tibias. There was one case of superficial infection. 12 legs (66.7%) developed ankle equinus after removing the external fixator. Four legs with severe equinus deformity were treated with percutaneous tendo-Achilles lengthening. Valgus deviation occurred in eight tibias. Peroneal nerve neuropraxia occurred in two legs during distraction. Distal migration of the fibula head occurred in four legs. CONCLUSION: Our study suggested that tibial lengthening using Nhan's external fixater or Muller frame then plating was safe and effective provided complications were looked for and kept in check. Equinus contracture, pin-site infection, and valgus alignment were the most common complications. LEVEL OF EVIDENCE: Level IV, prospective case series study.

Fibula lengthening then centralization for the treatment of pseudoarthrosis at the middle third of tibia with large leg-length discrepancy - A case report.

INTRODUCTION AND IMPORTANCE: Tibial dysplastic pseudoarthrosis associated with large leg-length discrepancy and extensive scarring was a great challenge for orthopedic surgeons. The treatment for these lesions was not defined. CASE PRESENTATION: We report a 24-year-old case of dysplastic pseudoarthrosis at the middle third of the right tibia with a 10 cm leg-length discrepancy and a 250 medial deviation and 200 internal torsion due to osteomyelitis 14 years previously. She was treated by fibula lengthening then centralization for the treatment of tibial pseudoarthrosis. Eight months after the operation, the patient reported no pain and became capable of walking without an orthosis. X-rays showed full bone union at the proximal tibiofibular synostosis and the lengthening site of the right fibula. The distal tibiofibular synostosis was healing. The range of movement of the knee and ankle was restored. CLINICAL DISCUSSION: This technique was different from the Huntington procedure. A good union between the transposed fibula and the remaining part of the fibula brought a better strength of the reconstructed tibia. The tibial pseudoarthrosis, leg-length discrepancy, and malalignment had been solved by our techniques. The procedure was easy, rapid, and inexpensive without requiring microsurgery skills and special devices. CONCLUSION: Leg lengthening then centralization of ipsilateral fibular graft is an excellent option for reconstruction of a tibial pseudarthrosis with a large leg-length discrepancy. It is a safe, rapid, and inexpensive procedure. The procedure was not difficult, and microvascular skills and special devices were not required. LEVEL OF EVIDENCE: A case report.