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An amendment to this paper has been published and can be accessed via the original article.
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BACKGROUND: Syndesmotic injuries are common and their incidence is rising. In case of surgical fixation of the syndesmosis a metal syndesmotic screw is used most often. It is however unclear whether this screw needs to be removed routinely after the syndesmosis has healed. Traditionally the screw is removed after six to 12 weeks as it is thought to hamper ankle functional and to be a source of pain. Some studies however suggest this is only the case in a minority of patients. We therefore aim to investigate the effect of retaining the syndesmotic screw on functional outcome. DESIGN: This is a pragmatic international multicentre randomised controlled trial in patients with an acute syndesmotic injury for which a metallic syndesmotic screw was placed. Patients will be randomised to either routine removal of the syndesmotic screw or removal on demand. Primary outcome is functional recovery at 12 months measured with the Olerud-Molander Score. Secondary outcomes are quality of life, pain and costs. In total 194 patients will be needed to demonstrate non-inferiority between the two interventions at 80% power and a significance level of 0.025 including 15% loss to follow-up. DISCUSSION: If removal on demand of the syndesmotic screw is non-inferior to routine removal in terms of functional outcome, this will offer a strong argument to adopt this as standard practice of care. This means that patients will not have to undergo a secondary procedure, leading to less complications and subsequent lower costs. TRIAL REGISTRATION: This study was registered at the Netherlands Trial Register (NTR5965), Clinicaltrials.gov ( NCT02896998 ) on July 15th 2016.
Assuntos
Traumatismos do Tornozelo/cirurgia , Parafusos Ósseos , Internacionalidade , Idoso , Fraturas do Tornozelo/diagnóstico , Fraturas do Tornozelo/cirurgia , Traumatismos do Tornozelo/diagnóstico , Parafusos Ósseos/efeitos adversos , Feminino , Seguimentos , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/instrumentação , Fixação Interna de Fraturas/métodos , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
PURPOSE: The aim of this prospective randomized trial was to test the null hypothesis that there was no difference in the percentage of the fracture line of scaphoid waist fractures that demonstrated bridging bone on computed tomography (CT) 10 weeks after injury between patients treated in a below-elbow cast including or excluding the thumb. METHODS: A total of 62 patients with a CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fracture of the scaphoid were enrolled in a prospective, multicenter, randomized trial comparing treatment in a below-elbow cast including or excluding the thumb. There were 55 waist and 7 distal fractures (owing to a miscommunication at 3 of the centers). We adhered to intention-to-treat principles. The primary outcome was the extent of union on CT performed after 10 weeks of cast treatment, expressed as a percentage of the fracture line that had bridging bone, determined by musculoskeletal radiologists blinded to treatment. Secondary study outcomes included wrist motion; grip strength; the Mayo Modified Wrist Score; the Disabilities of the Arm, Shoulder and Hand score; a visual analog scale for pain; and radiographic union at 6 months after injury. RESULTS: There was a significant difference in the average extent of union on CT at 10 weeks (85% vs 70%) favoring treatment with a cast excluding the thumb. The overall union rate was 98%. The 1 exception was a patient in the thumb immobilization group who elected operative treatment 1 week after enrollment, used crutches, and failed to heal. There were no significant differences between groups for wrist motion; grip strength; Mayo Modified Wrist Score; Disabilities of the Arm, Shoulder, and Hand score; or pain intensity. CONCLUSIONS: Immobilization of the thumb appears unnecessary for CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fractures of the waist of the scaphoid. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.
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Moldes Cirúrgicos , Imobilização , Osso Escafoide/lesões , Traumatismos do Punho/cirurgia , Adulto , Desenho de Equipamento , Feminino , Humanos , Imobilização/métodos , Masculino , Pessoa de Meia-Idade , Polegar , Resultado do Tratamento , Adulto JovemRESUMO
The increasing incidence of distal radius fracture is thought to be due to the aging population. Surprisingly, some authors have reported a decrease in the incidence of distal radius fracture. Moreover, the type-specific incidence of distal radial fracture classified according to fracture severity is not well documented. The aim of this population-based study was to estimate the overall and type-specific incidences of distal radius fracture in a urban population in The Netherlands. During 2009, all persons aged ≥18 years old with an acute distal radius fracture in two hospitals in The Netherlands were prospectively registered. In 2009, the mid-year study population consisted of 245,559 inhabitants ≥18 years old. Fractures were categorized according to the AO classification. 494 patients with acute distal radius fractures were registered in the two participating hospitals during the 1-year study period. The overall incidence of distal radius fracture was 20 per 10,000 person-years. Among women, the incidence rate increased from the age of 50 and reached a peak of 124 per 10,000 person-years in women 80 years and older. Among men, the incidence rate was low until the age of 80 years and older, and reached a peak of 24 per 10,000 person-years. The incidence rate among women between 50 and 79 years was 54/10,000 person-years. Extra-articular AO type A fractures were most common among all age groups, comprising 50 % of all fractures (40 % in men and 53 % in women). The overall incidence rate of distal radius fracture was 20 per 10,000 person-years. This incidence increases with age for both women and men. A lower incidence rate among women 50-79 years of age was found than previously reported, which may indicate a declining incidence in this age group. Extra-articular AO type A fractures were the most common fracture types.
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In the Netherlands, approximately 30,000 inguinal hernia repairs are performed yearly. At least 15% are for recurrence. New procedures are being introduced creating discussion on which technique is the best. Currently it is not possible to choose on evidence alone because of the long follow-up that is needed. In 1996 an inventory was taken of all inguinal hernia repairs that were performed in the Amsterdam region (9 hospitals). These results were compared with the results from a similar study performed in 1994. Major changes in treatment strategy were noted. The Bassini repair was replaced by Shouldice and Lichtenstein techniques. There was a significant increase in the use of prostheses for both primary and recurrent inguinal hernias. There was no significant decrease in the percentage of operations performed for recurrent hernia from 19.5% to 16.8%. However, there was a significant decrease in operations performed for early recurrences (5.1%-3.4%) (p = 0.05). These results suggest that the Shouldice and Lichtenstein repairs may be superior to the Bassini repair in terms of early hernia recurrence.