Rationale and design of The Delphi Trial – I(RCT)(2): international randomized clinical trial of rheumatoid craniocervical treatment, an intervention-prognostic trial comparing 'early' surgery with conservative treatment [ISRCTN65076841]

BACKGROUND: Rheumatoid arthritis is a chronic inflammatory disease, which affects 1% of the population. Hands and feet are most commonly involved followed by the cervical spine. The spinal column consists of vertebrae stabilized by an intricate network of ligaments. Especially in the upper cervical spine, rheumatoid arthritis can cause degeneration of these ligaments, causing laxity, instability and subluxation of the vertebral bodies. Subsequent compression of the spinal cord and medulla oblongata can cause severe neurological deficits and even sudden death. Once neurological deficits occur, progression is inevitable although the rapidity of progression is highly variable. The first signs and symptoms are pain at the back of the head caused by compression of the major occipital nerve, followed by loss of strength of arms and legs. The severity of the subluxation can be observed with radiological investigations (MRI, CT) with a high sensitivity. The authors have sent a Delphi Questionnaire about the current treatment strategies of craniocervical involvement by rheumatoid arthritis to an international forum of expert rheumatologists and surgeons. The timing of surgery in patients with radiographic instability without evidence of neurological deficit is an area of considerable controversy. If signs and symptoms of myelopathy are present there is little chance of recovery to normal levels after surgery. DESIGN: In this international multicenter randomized clinical trial, early surgical atlantoaxial fixation in patients with rheumatoid arthritis and radiological abnormalities without neurological deficits will be compared with prolonged conservative treatment. The main research question is whether early surgery can prevent radiological and neurological progression. A cost-effectivity analysis will be performed. 250 patients are needed to answer the research question. DISCUSSION: Early surgery could prevent serious neurological deficits, but may have peri-operative morbidity and loss of rotation of the head and neck. The objective of this study is to identify the best timing of surgery for patients at risk for the development of neurological signs and symptoms

Artrodesis C1C2 con tornillos transarticulares en artritis reumatoidea: experiencia y revisión de la literatura Artrodese C1 C2 com parafusos transarticulares em artrite reumatoide: experiência e revisão de literatura C1 C2 arthrodesis with transarticular screws in rheumatoid arthritis: experience and literature review

OBJETIVO: Describir los resultados clínicos e imagenológicos utilizando la técnica de fijación C1 C2 con tornillos transarticulares y asas de alambre en pacientes portadores de AR en un seguimiento a largo plazo y revisar la literatura actual. MÉTODO: Entre los años 2002 y 2006, 11 pacientes (9 mujeres y 2 hombres) con inestabilidad C1 C2 secundaria a AR fueron intervenidos quirúrgicamente. Se realizó fijación C1 C2 con tornillos transarticulares por vía posterior más asas de alambre y aplicación de injerto óseo autólogo de cresta ilíaca. Se registró Índice de Ranawat pre y posoperatorio, Distancia Anterior Atlas Odontoides (DAAO) pre y posoperatorio, tiempo operatorio, días de hospitalización, complicaciones intra y posoperatorias y tiempo de consolidación radiológica, con un seguimiento promedio de 34 meses. RESULTADOS: Todos los pacientes presentaron mejoría del Índice de Ranawat en el postoperatorio. La DAAO preoperatoria promedio fue de 11,9 mm (DS ± 2,57), rango 7 a 16, y la DAAO postoperatoria promedio fue de 3 mm (DS ± 1,20), rango 2 a 6. El tiempo quirúrgico fue de 94 minutos en promedio y el promedio de días de hospitalización fue de 7 días. No se presentaron complicaciones intraoperatorias. Un caso presentó seroma de herida operatoria que requirió tratamiento quirúrgico. El tiempo de consolidación fue en promedio 14 semanas. CONCLUSIÓN: La artrodesis atlantoaxial con tornillos y amarras es una buena alternativa para el manejo de la inestabilidad C1-C2 en pacientes portadores de AR, consiguiendo buenos resultados clínicos e imagenológicos en un seguimiento a largo plazo.<br>OBJETIVO: Apresentar a experiência com a técnica de fixação C1-C2 com parafusos transarticulares e cerclagem de fio metálico nos pacientes portadores de AR, assim como a revisão da literatura. MÉTODO: Entre os anos 2002 e 2006, 11 pacientes (9 mulheres e 2 homens) com instabilidade C1-C2 e portadores de AR foram submetidos a tratamento cirúrgico. Foi realizada a fixação C1-C2 com parafusos transarticulares por via posterior e cerclagem com fio metálico e enxerto autólogo. O Índice de Ranawat pré e pós-operatorio foi registrado, assim como a distância anterior atlas-dontoide (DAAO), o tempo operatório, os dias de hospitalização, as complicações trans e pós-operatórias e o tempo de consolidação. O seguimento médio foi de 34 meses. RESULTADOS: Todos os pacientes apresentaram melhora do Índice de Ranawat no pós-operatório, a DAAO pré-operatória média foi de 11,9 cm (DP ± 2,57), variação de 7 a 16, e a DAAO pós-operatória média foi de 3 cm (DP ± 1,20), com a variação de 2 a 6. O tempo cirúrgico médio foi de 94 minutos e o período médio de de hospitalização foi 7 dias. Não foram observadas complicações intraoperatórias. Um paciente apresentou seroma de ferida operatória que necessitou de tratamento cirúrgico. O tempo de consolidação foi em média 14 semanas. CONCLUSÃO: A artrodese atlanto-axial com parafusos e cerclagem com fio metálico é uma boa alternativa no tratamento da instabilidade C1-C2 nos pacientes portadores de AR, proporcionando bons resultados clínicos e radiológicos.<br>OBJECTIVE: Present the long term clinical and radiological results in C1-C2 transarticular screws technique with posterior wiring in RA patients and presenting the current literature review. METHODS: From 2002 to 2006, eleven patients (9 women and 2 men) with RA and C1-C2 instability underwent C1-C2 arthrodesis with transarticular screws plus posterior wiring and autologous iliac crest bone graft. A retrospective chart and radiographic review was performed. Ranawat Index was recorded in pre- and post-operative, as well as anterior atlantodental interval (AADI), operating time, days of hospitalization and complications. The mean follow up (FU) was 34 months. RESULTS: All patients presented improved Ranawat Index at follow up. Average pre-operative AADI was 11,9mm (SD ± 2,57), range 7 to 16. Average post-operative AADI was 3mm (SD ± 1.20), range 2 to 6. The average operating time was 94 minutes and the average days of hospitalization was 7 days. No intra-operative complications were found. Post-operative seroma was found in one case and surgical drainage was required. All patients achieved solid fusion at 14 weeks in average. CONCLUSIONS: C1-C2 arthrodesis with transarticular screws plus posterior wiring and autologous bone graft is a good alternative for atlantoaxial instability due RA, with good clinical and radiographic outcomes

Large bone distractor for open reconstruction of articular fractures of the calcaneus

The results of operative treatment of two groups of patients with articular fractures of the calcaneus were evaluated. Twenty-three cases were treated surgically using a standard reconstruction procedure. In the second group of 19 patients a large bone distractor was used; it held the soft tissue flap retracted, while aiding in articular and tuberosity fragment reduction and increasing visualisation by distraction of the posterior talocalcaneal joint. After a year, the anatomical and functional results, together with the operative time, were evaluated. All fractures healed with good or very good anatomical results. All cases, except those with complications (n = 3), achieved good (n = 28) or very good (n = 11) functional scoring. The distractor group had significantly shorter operative times, and less manpower was needed during surgery. We conclude that the large bone distractor is a useful tool in open reconstruction of articular calcaneal fractures