Around half of UK surgeons add metal screws and rods to a spinal decompression operation for a common form of progressive paralysis, and half do not—and no one knows which approach is better. This uncertainty matters because Degenerative Cervical Myelopathy (DCM) affects up to 2% of adults. Arthritis in the neck slowly crushes the spinal cord, causing loss of hand function, balance problems, and eventually incontinence or tetraplegia. Surgery can stop the damage, but fewer than 5% of patients fully recover, half remain dependent on others, and half never return to work. For patients needing surgery at three or more spinal levels, the best surgical technique is unknown. The trial will randomly assign 394 patients across 30 hospitals to receive either decompression alone or decompression with metal fixation. It will measure neuromuscular function at 24 months, along with patient-reported outcomes from a standardised core dataset developed with patient input. If fixation proves beneficial, patients could regain more function and avoid late spinal deformity. If it does not, the NHS could save significant costs from unnecessary metal implants and longer operations. Either result gives surgeons a clear, evidence-based choice for a common, disabling condition.
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What is the clinical and cost-effectiveness of fixation for multi-level Degenerative Cervical Myelopathy undergoing posterior surgery? Degenerative Cervical Myelopathy [DCM] is a common and disabling condition arising when arthritic changes in the cervical spine [degenerative], compress and injure the cervical spinal cord [cervical], causing a progressive, slow-motion spinal cord injury [myelopathy]. Compression can be static, but also dynamic (related to movement of the spine). It is estimated to affect up to 2% of adults and leads to a progressive loss of dexterity, gait disturbance, imbalance, and in severe forms incontinence and tetraplegia. Surgery is the only effective treatment. It aims to remove any compression on the spinal cord and is able to stop disease progression and offer meaningful, albeit incomplete, recovery. Today <5% make a full recovery, with 50% dependent on others and 50% unable to return to work. Improving outcomes from DCM surgery is a James Lind Alliance research priority. There are a number of different operations used for DCM treatment. If the arthritic changes affect multiple levels or when the changes occur mainly behind the spinal cord, the favoured surgery is posterior, either 1) decompression (laminectomy) alone, or 2) decompression and fixation using metal implants to stabilise the spine (laminectomy and fusion). Those in favour of (2) ‘laminectomy and fusion’ argue that the additional metalwork prevents patients developing symptoms from deformity (abnormal alignment of the spine) and subsequent dynamic (as the result of movement) spinal cord injury. Those in favour of (1) ‘laminectomy alone’ feel that although deformity may occur, it does not have a negative impact for the patient, but fixation comes with significant additional healthcare cost and operative complexity. This question remains pertinent to multi-level disease, surgery for which has greater biomechanical implications and has not been covered by existing trials (as summarised by this funding call). Consequently today, about half of UK surgeons prefer (1) and half (2). We propose a randomised controlled trial of 394 patients from 30 sites (20-25 UK and 5-10 International): P: Adults (>18) with a diagnosis of DCM, scheduled to undergo treatment at 3 or more levels I: Posterior Decompression and Fusion (Laminectomy and Fusion) C: Posterior Decompression (Laminectomy) O: mJOA (Modified Japanese Orthopaedic Association) It is powered to detect a mean difference of 1 and a SD of 2.88 in neuromuscular function (DCM patient recovery priorities) as measured using mJOA Neuromuscular Function Scale at 24 months. A range of additional outcome measures have been selected in line with our DCM Core Dataset initiative (www.recode-dcm.com). It has been endorsed by a focus group of people with DCM. The trial will run over 75 months, including 6 months set-up, 9 months internal pilot (10 sites, recruiting 40 patients), 30 months substantive recruitment phase (further 20 sites) and 6 months closure. We anticipate the proposed trial will provide a robust evidence base for the optimal surgical strategy for patients who suffer multi-level DCM and require posterior surgery. It will either identify a patient benefit to fixation, or if not, provide significant cost saving to the NHS. The research findings will be disseminated with the help of patients, through professional conferences, healthcare policy and online media.
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