Arthritis Research UK Orthopaedic Clinical Studies Group: Spine BASS / BSS / SBPR Agenda Introduction Spinal conditions are very common and are largely treated non-operatively. The annual incidence of low back pain is approximately 30-40% and the prevalence of symptomatic lumbar disc herniation is approximately 2%. Thankfully both these conditions have an excellent natural history. Spinal surgery is performed by both Orthopaedic Surgeons and Neurosurgeons and the Orthopaedic Clinical Studies Group represents both sub-specialities for the purpose of spinal research. The spinal conditions of relevance to ARUK include: Degenerative conditions Deformity Infection Trauma There already exists a ‘Musculoskeletal Pain Disorders Studies Group’ which includes a research agenda for the conservative management of spinal conditions. The Executive Committees of the three Spinal Societies have considered the research priorities in each of the above areas and the following agenda lists areas considered to advance knowledge or improve patient care in surgical procedures, basic science related to surgical pathology, and rehabilitation around surgical conditions. Research grants are available for all aspects of research into spinal conditions where the condition is either primarily degenerative or may lead to a degenerative condition. However, preference will be given to projects which address the key areas of research identified in the categories below. All aspects of spinal research methodology will be considered including basic science, epidemiology and clinical research. For clinical studies, randomised, prospective studies must address a particularly important question. Prospective cohort studies, especially involving multi-centres with good evaluation of outcomes will be considered. The British Association of Spine Surgeons (BASS) are producing a National Spine Registry which will be non-mandatory, free to all users and allow different ‘levels’ of data collection depending on the surgeon’s enthusiasm and available local resources. Data can be collected on all spinal conditions including degenerative, deformity, trauma, tumour and infection. The data collected will include: Diagnosis Additional details including neurological deficit Operative details Complications Patient Reported Outcome Measures (PROMs) The Registry will also provide a mechanism for data collection in approved research studies especially where these are multi-centre or involve PROMS. 1. Spinal Degenerative Disease Degenerative change in the cervical and lumbar spine can result in ‘axial’ pain, localised to the neck or low back. Nerve root compression either from a disc protrusion or secondary to degenerative change can result in radiculopathy (pain and/or weakness) in upper or lower limbs. Compression of the central neurological structure can produce symptoms of spinal cord compression which can be slow onset (cervical myelopathy) or occasionally of rapid onset or symptoms of cauda equina compression which can also be of slow onset (lumbar spinal stenosis) or rapid onset (cauda equina syndrome). These problems affect a large number of patients each year with about 30-40% experiencing significant back pain lasting more than 24 hours each year. It was estimated in 2000 that approximately £1.6 billion is spent treating back problems. On average 1% of the working population are on sick leave due to back pain on any one day resulting in 5 million lost working days at a cost to business of £600m. In the UK in 2002, it was estimated that the cost of back pain was 1-2% of GDP. Key directions of future research: Basic science: o Evaluation of disc degeneration and regeneration. o Chemical mediation of radicular pain. Epidemiology: o Natural history of degenerative conditions including degenerative or lytic spondylolisthesis and lumbar spinal stenosis. o Evaluating cohorts with the same initial symptom to determine an optimal care pathway both in terms of patient outcome and economic analyses with the aim of improving quality of life for the most number of patients in the most economic way. Non-surgical management (where patients can be recruited in spinal surgical clinics): o Is physiotherapy beneficial in acute lumbar radicular pain (NIHR funded pilot study 2011)? o Is physiotherapy beneficial in lumbar spinal stenosis? o Prognostic factors in acute low back pain and acute cervical/lumbar radicular pain. Surgery: o How to measure surgical outcomes. o Studies to enhance our knowledge of improving overall outcome with improved patient selection. o Evaluation of new treatment methods. o Effect of different surgical techniques / approaches on outcome eg: In lumbar discectomy should we just remove the compressing fragment or perform an aggressive disc clearance? Bone graft substitutes versus iliac crest bone graft (cost-effectiveness). In non-resolving cervical radicular pain should we do an anterior cervical discectomy and fusion or a cervical disc replacement? o Prognostic indicators of surgical outcome eg are selective nerve root injections prognostic in the outcome of lumbar/cervical decompression surgery in cases with equivocal symptoms or MRI scan? o Influence of rehabilitation before and/or after surgical procedures on the outcome of spinal surgery. o Exploration of care pathways and patient needs in relation to surgery. 2. Deformity Idiopathic scoliosis in childhood (infantile, juvenile and adolescent idiopathic scoliosis) is thought to be associated with an increased risk of back pain in adult life with surgery of unproven benefit in reducing this risk. Degenerative scoliosis is a de-novo scoliosis usually in the lumbar spine secondary to degenerative change in the lumbar facet joints and intervertebral discs. Patients present with any combination of lumbar pain, radicular pain and deformity with frontal and sagittal plane imbalance. With an aging population, the incidence is increasing but as with other types of scoliosis, the incidence varies with curve severity. The options for conservative management are currently limited. Surgery achieves good deformity correction and prevents curve progression and has very good success at relieving radicular pain but only moderate success at improving lumbar back pain. The risks of scoliosis surgery in this elderly population are high with complication rates of over 70%. All studies of scoliosis should define which curve types and curve sizes are included in the study. Key directions of future research: Basic science: o Finite element modelling of deformity progression. o Biomechanical evaluation of surgical methods of spinal deformity correction including implant design. Epidemiology: o Long-term natural history of treated and untreated adolescent idiopathic scoliosis eg does surgical correction improve low back pain long-term in thoracolumbar adolescent idiopathic scoliosis. o Natural history of untreated degenerative scoliosis. Non-surgical management: o Brace treatments for adolescent idiopathic scoliosis. o Evaluation of new treatment methods. o Exercise therapy for adolescent idiopathic scoliosis (HTA study 2011). Surgery: o Operative treatment of adolescent idiopathic scoliosis aiming to reduce longterm disability. o How to measure surgical outcomes in scoliosis. o Evaluation of new treatment methods. o Studies to enhance our knowledge of improving overall outcome with improved patient selection in degenerative scoliosis. o Effect of different methods of surgical techniques / approaches on long term outcome in degenerative scoliosis eg stopping at L5 versus S1, unilateral fusions to support exit foramen decompressions. o Importance of sagittal balance in degenerative scoliosis and techniques to most safely achieve acceptable alignment. o Influence of rehabilitation before and/or after surgical procedures on the outcome of spinal surgery. 3. Infection Spinal infections are considered to be rare but hospital MDTs have shown that these cases are under the care of numerous departments within the hospital and are therefore more common that generally believed. Diagnosis is often delayed as patients present with back pain which is a very common symptom. Once diagnosed (usually on MRI), a successful non-surgical outcome is thought to be more likely if the infecting organism can be identified on blood cultures or biopsy and treated with appropriate antibiotics for a prolonged period. Surgical procedures are uncommon but when needed are usually performed in very unwell patients and complication rates are high. Key directions of future research: Basic science: o Evaluate the products of staphylococcus aureus that seem to promote spinal fusion. o Techniques to improve microbiology yield from biopsies. Epidemiology: o Disease burden. o Natural history. o Prognostic factors eg microbiology, radiological and MRI predictors of progressive bone destruction requiring surgical stabilisation. Non-surgical management: o Optimal antibiotic regime for different types of infection including route of administration and length of time. o Effect of diet on outcome. Surgery o Studies aimed at improving our knowledge of early clinical and radiological indicators for operative intervention. o Effect of different methods of surgical techniques / approaches on outcome eg posterior stabilisation versus posterior stabilisation and decompression versus posterior stabilisation and anterior decompression. 4. Trauma Spinal trauma is common and is often managed conservatively. We are unsure how our management affects long-term outcome. Key directions of future research: Basic science: o Biomechanics of reconstruction. unstable fractures with relation to stability Epidemiology: o Is adjacent disc damage relevant in the management of vertebral fractures. after Non-surgical management: o Necessity for and length of time of brace treatment in thoracolumbar fractures. o Role of early physiotherapy in the management of stable thoracolumbar fractures. Surgery: o Effect of different methods of surgical techniques / approaches eg minimally invasive stabilisation v open stabilisation, necessity for spinal fusion. o Prognostic factors eg the effect of sagittal balance on surgical decision making. o Early operative management versus conservative management of type II odontoid fractures in the elderly. o Does physiotherapy improve the long-term outcome after surgical stabilisation of vertebral fractures? o The management of post-traumatic kyphosis.