Title: POsterior Laminectomy and FIXation for Degenerative Cervical Myelopathy [POLYFIX-DCM]
Funder: Department of Health and Social Care

Abstract: Degenerative Cervical Myelopathy is a common condition caused when arthritic changes in the neck compress the spinal cord. It affects up to 2% of adults and causes numb and clumsy hands, imbalance, and bladder problems. Often it continues to worsen with time and sometimes it leads to severe disability and becoming wheelchair bound._x000D_ _x000D_ The only current treatment is surgery. It is able to stop further deterioration and lead to some improvements. However, only a few patients (less than 5%) will make a full recovery, leaving half dependent on others and half unable to return to work. _x000D_ _x000D_ The aim of surgery is to create space for the spinal cord and a number of different operations are used. _x000D_ _x000D_ For those who need surgery from the back of her neck, there are two options: a) a simple removal of bone behind the spinal cord (laminectomy), or b) removal of the bone and stiffening of the neck using metal implants (laminectomy and fusion)._x000D_ At present we do not know which of these approaches is better. Stiffening (laminectomy and fusion) of the neck restricts movements but is able to prevent longer term ‘deformity’ of the neck, which would otherwise affect 6 in 10 people. _x000D_ Deformity or ‘malalignment of the spine’, can be painful and may require further surgery. Additionally, some findings suggest that it may cause further spinal cord damage in the future._x000D_ _x000D_ On the other hand, only removing the bone (laminectomy alone) is a simpler and cheaper option and does not reduce range of movement in the neck. _x000D_ Surgeons advocating for one or the other approach are split approximately half and half. Finding out whether one approach is better than the other is an important research priority, according to patients and professionals._x000D_ Our consortium brings together diverse specialists involved in the care and research of DCM with a track record in clinical research. These include surgeons, primary care practitioners, neurologists, researchers, and therapists, but also individuals living with DCM._x000D_ _x000D_ We propose to address the following question:_x000D_ _x000D_ ‘Does laminectomy alone or laminectomy with fusion lead to better recovery in patients undergoing surgery for DCM from the back’?_x000D_ _x000D_ Our trial will involve 394 patients across 30 sites, mainly based in the UK. It is designed to enable a better understanding and better choices with regards to surgery for this condition.

Lay abstract: What is the clinical and cost-effectiveness of fixation for multi-level Degenerative Cervical Myelopathy undergoing posterior surgery?_x000D_ _x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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)._x000D_ _x000D_ 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._x000D_ _x000D_ 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)._x000D_ _x000D_ We propose a randomised controlled trial of 394 patients from 30 sites (20-25 UK and 5-10 International):_x000D_ _x000D_ P: Adults (>18) with a diagnosis of DCM, scheduled to undergo treatment at 3 or more levels_x000D_ I: Posterior Decompression and Fusion (Laminectomy and Fusion)_x000D_ C: Posterior Decompression (Laminectomy)_x000D_ O: mJOA (Modified Japanese Orthopaedic Association)_x000D_ _x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ 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.

Research activity codes: 6.4 SURGERY
Health categories: MUSCULOSKELETAL;NEUROLOGICAL