A. Clinical Studies Group: Orthopaedic Surgery Chair: Professor Damian Griffin Disease/disorder covered: Orthopaedic Surgery This research strategy maps out the direction for orthopaedic clinical research. It is intended to describe the priority areas most likely to be supported by the Orthopaedic Surgery CSG. By focusing on these priority areas, Arthritis Research UK will be able to achieve maximum potential from its research grants for the benefit of patients who may need orthopaedic surgery. The CSG has looked for the most pressing questions about the treatment of musculoskeletal disease and injury in order to address a range of problems that frequently threaten people s quality of life. With the increasing proportion of the elderly in the population and their very reasonable desire to live life to the full for as long as possible, these questions are more urgent than ever. This research strategy is not exhaustive of all that surgeons can treat in the musculoskeletal system; it focuses on the priority areas that affect the largest number of people. In each section, we describe the burden of disease caused by each condition and then identify the new knowledge that is needed to improve our ability to reduce that burden. The Orthopaedic Surgery Clinical Studies Group will promote research: 1. Which investigates which surgical interventions should be used to treat musculoskeletal disease, when, how and in whom; 2. Is of the highest quality, tractable, innovative in design and concentrates on outcomes of importance to patients; 3. Tackles problems which are common or serious and of national and international importance; 4. Addresses national and international health priorities identified by the NHS, professional bodies, patients groups, guideline development groups and funders; and 5. Is relevant to the ten goals of Arthritis Research UK. B. Development of the strategy Sources used to inform strategy We developed this strategy from previous work conducted by the British Orthopaedic Association, the Bone and Joint Decade, the British Orthopaedic Research Society, the American Academy of Orthopaedic Surgeons, The British Geriatrics Society, The International Society for Fracture Repair, The National Osteoporosis Society and The International Osteoporosis Foundation. We made particular use of the British Orthopaedic Foundation Research Agenda. Orthopaedic Surgery CSG Strategy 2012 Page 1
A horizon scanning exercise was performed by Nadia Corp, which informed development of a draft strategy. Members of the CSG then discussed the strategy with sub-specialist societies of the British Orthopaedic Association including the British Association for Surgery of the Knee, British Association of Spine Surgeons, British Scoliosis Society, Society for Back Pain Research, British Elbow and Shoulder Society, British Hip Society, British Orthopaedic Foot and Ankle Society, British Society for Children s Orthopaedic Surgery, British Society for surgery of the Hand, and the British Trauma Society. Specialist societies were particularly invited to submit exemplar clinical research questions considered to be of high priority in that sub-specialty. Each approached this differently, engaging with their membership through discussions at national meetings or surveys. The hip and knee societies took part in meetings to develop a research strategy around hip and knee arthroplasty and submitted the outcomes of this as the highest research priorities in hip and knee surgery. There is some overlap between this CSG and other CSGs in Arthritis Research UK. Where a research question is relevant to two or more CSGs, the Orthopaedic Surgery CSG will take the lead if the intervention being studied is usually performed by surgeons. We have divided research themes and questions into: 1. Arthritis and arthroplasty 2. Musculoskeletal trauma 3. Soft tissue disorders including sports injuries 4. Spinal disorders 5. Childhood musculoskeletal disorders We expect this to be a developing document, and plan for an annual review by the whole orthopaedic community, timed to coincide with the Annual Congress of the British Orthopaedic Association. The next review will begin in September 2012. C. Emerging Therapeutic and Related Areas C1. Arthritis and arthroplasty Osteoarthritis accounts for half of all chronic conditions in people aged over 65. Some 25% of people over the age of 60 have significant pain and disability from osteoarthritis. Osteoarthritis leads to pain, deformity, and loss of joint motion as protective cartilage within the joint is damaged and diminished, leaving sensitive bone exposed and vulnerable to abrasion and destruction. Osteoarthritis is the most common form of arthritis and is a leading cause of disability worldwide. The incidence of osteoarthritis increases with age, and disproportionately affects women. The economic consequences of osteoarthritis are enormous. Page 2 Page 2 Page 2 Orthopaedic Surgery CSG Strategy 2012 Page 2
Arthroplasty, including hip and knee replacement, is highly effective and cost effective. About 160,000 hip and knee replacements are performed each year in the UK. Understand the risk factors for the development of osteoarthritis and develop early interventions to reduce the burden of disease. Understand which patients should be treated with arthroplasty or other surgical procedures, and when during the development of arthritis. Define best practice in terms of which arthroplasty to perform, how, where and who to do it, and how patients can best live a fulfilling life after arthroplasty. Comparison of joint preserving surgery with non-operative care. Comparison of arthroplasty with non-operative care. Comparison of arthroplasty with joint fusion (especially in the ankle, foot, wrist and hand). How can surgery best contribute to the care of patients with inflammatory arthropathy of the hand? Comparison of different pathways of care for patients needing arthroplasty. How should surgeons be trained to perform arthroplasty? C2. Musculoskeletal trauma Worldwide, 25% of health care expenditure was on trauma in 2010. Musculoskeletal trauma includes fractures, dislocations, open wounds, amputations and damage to nerve and blood vessels: These injuries commonly lead to arthritis and musculoskeletal pain and disability. Road traffic accidents are the commonest cause of such injuries; 320,000 each year in the UK. Falls are the second commonest mechanism of injury, accounting for 30% of emergency cases and are associated with the second largest number of hospital and ICU days. Osteoporosis is a major contributor to fractures, especially of the hip, spine and wrist, associated with 180,000 fractures each year in UK women, and costing 1.7 billion each year. (There is recognised overlap with the Bone Mineral Diseases CSG which includes priorities in the management of osteoporosis). Comparison of operative and non-operative care for fractures. Comparison of different operative strategies. Avoidance of delayed and non-union. Reduce risk of arthritis after fractures and joint injuries. Optimisation of the organisation and delivery of trauma services. Page 3 Page 3 Page 3 Orthopaedic Surgery CSG Strategy 2012 Page 3
The CSG will not support studies that concentrate on the systemic effects of multiple injuries or on non-musculoskeletal injuries. Comparison of internal fixation plate osteosynthesis versus non-operative treatment for nightstick fractures of ulnar diaphysis in adults. Comparison of cemented hemiarthroplasty versus cemented total hip arthroplasty for displaced intracapsular hip fractures. Comparison of clavicular hook plate fixation versus Surgilig reconstruction for Neer 2 fractures of the distal clavicle in adults. Does structured rehabilitation improve outcomes and independence following surgical treatment of hip fractures? C3. Soft tissue disorders including sports injuries Soft tissue disorders include, tendonopathy, bursitis, sprains, strains, ligament injuries, muscle tears, tenosynovitis, and nerve compression syndromes. In the UK, soft tissue injuries and conditions account for 3 million Emergency Department visits, 1 million outpatient visits and 1.5 million bed-days each year. There are an estimated 2 million sports injuries per year in the UK; 95% involve soft tissues. More than 50% of knee injuries result from sports-related activities. Cumulative trauma disorders, including carpal tunnel syndrome, tendonitis, tenosynovitis, repetitive strain injury and bursitis, account for 64% of all occupational illnesses. Novel treatments for soft tissue disorders including biological agents and tissue engineering. Define the role of surgery in managing soft tissue disorders. Comparison of surgical versus non-surgical treatment of acute ruptures of the Achilles tendon. Does subacromial injection of PRP result in better clinical outcomes when compared with subacromial corticosteroid injection in conservative treatment of impingement syndrome? Does post surgical injection of PRP in subacromial space improve outcome following arthroscopic subacromial decompression for impingement syndrome? What is the best strategy for treatment of Dupuytren s disease? Page 4 Page 4 Page 4 Orthopaedic Surgery CSG Strategy 2012 Page 4
C4. Spinal disorders There is recognised overlap with the Musculoskeletal Pain CSG which includes priorities in conservative treatment of back pain. The spine maybe affected by trauma, tumour, infection, inflammatory disease, osteoporosis, deformity and degenerative conditions such as disc degeneration, spinal stenosis and spondylolisthesis. Over 70% of people in developed countries will experience low back pain at some point in their life. General Practice consultations for low back pain have been estimated at 14-15 million per year in the UK. Back pain is the second leading cause of sick leave in the United Kingdom. Disability resulting from low back pain has become a public health problem accounting for 119 million days of incapacity. 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. Scoliosis is a common diagnosis, involving lateral (sideways) curvature of the spine, affecting 10% of adolescents. It may be the result of different diseases or conditions, including spina bifida, cerebral palsy, or muscular dystrophy, although in 90% of cases the cause is unknown. Treatment of the curves is required in 3 to 5 per 1,000. Understand which patients with spinal degenerative disease can benefit from surgery. Understand when to use different surgical strategies for the management of back pain, radicular pain and degenerative scoliosis. Comparison of operative and non-operative treatments for spinal conditions including infection and trauma. Understanding how post-operative management, including rehabilitation, can optimise outcome. Emerging technologies in the management of degenerative spinal conditions and conditions which may result in degenerative spinal conditions. 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? Page 5 Page 5 Page 5 Orthopaedic Surgery CSG Strategy 2012 Page 5
Prognostic indicators of surgical outcome e.g. are selective nerve root injections prognostic in the outcome of lumbar/cervical decompression surgery in cases with equivocal symptoms or MRI scan? Influence of rehabilitation before and/or after surgical procedures on the outcome of spinal surgery. Effect of different methods of surgical techniques / approaches e.g. minimally invasive stabilisation v open stabilisation, necessity for spinal fusion. Prognostic factors e.g. the effect of sagittal balance on surgical decision making in degenerative scoliosis. Early operative management versus conservative management of type II odontoid fractures in the elderly. Does physiotherapy improve the long-term outcome after surgical stabilisation of vertebral fractures? The management of post-traumatic kyphosis. C5. Children s orthopaedics There is recognised overlap with the Paediatric CSG. Cerebral palsy is the most prevalent physical disability originating in childhood. It affects 150,000 individuals in the UK, including about 2,000 babies per year at birth. Cerebral palsy is a group of non-progressive motor function disorders caused by lesions or anomalies of the brain. Its aetiology is not well understood. It may occur from low birth weight, illness, infection or injury. Prevalence of 2.4 per 1,000 children aged 3-10 years is increasing due to survival of very low birth weight infants. Clubfoot is a congenital foot deformity with an incidence of 1 in 735 births and with an incidence in males twice that of females. If a family has one child with clubfoot, the risk in subsequent siblings is 3% to 4%. If one parent and one child in a family have clubfoot, subsequent children have a 25% chance of having clubfoot. Congenital dislocation of the hip is a common orthopaedic condition in infants and children, affecting 1 in 750 children. Outcome measures for early treatment are poor and there is a real problem in respect of screening for the disorder. Children whose hip displacement is diagnosed between the ages of one and five, if left untreated will eventually develop osteoarthritis which can necessitate teenage hip joint replacement. The incidence of late presentation is high. Slipped capital femoral epiphysis is the most common hip disorder in young teenagers. It occurs when there is a period of rapid growth and shearing stress, frequently from excessive body weight, causes the femoral epiphysis to displace. Urgent surgical treatment is needed to stabilise the epiphysis by screw fixation. There is a high incidence of late morbidity caused by residual deformity. Perthes disease affects 1 in 8,000 young people. It causes the femoral head (ball of the hip joint) to lose its blood supply leading to deformity of the femoral head and an increased risk of fracture. The aetiology is not fully understood and the question of treatment is open to debate. Originally, patients were Page 6 Page 6 Page 6 Orthopaedic Surgery CSG Strategy 2012 Page 6
treated with bed rest, immobilisation and weight relief. The modern therapeutic approach embraces the concept of containment of the femoral head by operative or non-operative means. Osteogenesis imperfecta (Brittle Bone Disease) is a genetic disorder of connective tissue causing bone fragility and multiple long bone fractures. There is a spectrum of severity of the disease. In its mildest form, an apparently normal child may sustain few fractures and the distinction between osteogenesis imperfecta and non-accidental injury may be unclear. In the severe types, there are progressive bowing deformities of long bones and the spine and growth retardation. In most individuals, there is a genetically determined defect in type I collagen. Juvenile rheumatoid arthritis is the most common form of arthritis in children, affecting 10,000 to 20,000 children under 16 years of age in the UK. It is an autoimmune disease in which the body attacks its own healthy cells and tissues. Osteomyelitis is an infection in bone, usually bacterial in origin, affecting about 1 in 10,000 children. Symptoms include pain, soft tissue swelling, bone tenderness, and malaise. Septic arthritis is a common childhood condition in which bacteria settle into the joint. Its aetiology is unknown, but serious cases can result in joint destruction or death. Improve the evidence to support treatment of common childhood musculoskeletal disorders. Comparison of surgical interventions for poor prognostic groups in Perthes disease (Herring C). Test of novel treatments in Perthes disease e.g. Injected BP +/- BMP, RANKL inhibitor. Comparison of interventions for slipped epiphysis e.g. Open reduction vs. in situ pinning for moderate slips, surgical dislocation vs. anterior/anterolateral approach for reduction. In developmental dysplasia of the hip, comparison of early (medial) open reduction for failed closed reduction vs. delayed until appearance of ossific nucleus. Comparison of surgical strategies in cerebral palsy. Page 7 Page 7 Page 7 Orthopaedic Surgery CSG Strategy 2012 Page 7