Summary

Degenerative Cervical Myelopathy (DCM) 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 left untreated can lead to severe disability and paralysis.

o The only current treatment is surgery, and a number of different operations are used. The aim of surgery is to create space for the spinal cord. Often surgery has to be performed at multiple levels of the spine to remove the compression. Surgery is able to stop further deterioration and lead to some improvements.

For those who need surgery from the back of their neck, there are two options: a) 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).

o 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 malalignment of the spine, which may otherwise affect 6 in 10 people.

o Malalignment of the spine, can be painful and may require further surgery. Some findings suggest that malalignment may cause further spinal cord damage in the future.

o Only removing the bone (laminectomy) is a simpler and cheaper option and does not reduce range of movement in the neck.

o Surgeons advocating for one or the other approach are split approximately half and half. Finding out whether one approach is superior is an important research priority according to both patients and professionals.

We propose to address the following question, using a randomised controlled trial:

‘Does laminectomy alone or laminectomy with fusion lead to better recovery in patients undergoing surgery for DCM from the back’?

o People scheduled to undergo posterior surgery for DCM will be allocated using a computer to one or other treatment. This will involve 394 patients across 30 sites, mainly based in the UK. Overall, it is designed to enable a better understanding and better choices with regards to surgery for this condition.

What is the role of fixation for multi-level DCM

Purpose of Clinical Trial

To define best practice in the use of posterior spinal fixation for individuals undergoing multi-level posterior surgery for DCM .

Primary Objective

Mean difference in modified Japanese Orthopaedic Association score at 24 months after laminectomy compared to laminectomy and fusion

Secondary Objectives

1. To compare pain, physical function, quality of life, spinal alignment and adverse events..

2. To undertake a detailed economic evaluation..

Design

Multi-centre, pragmatic, randomised control trial

Study Size

Recruitment of 394 participants in total (pilot stage will run)

Summary of eligibility criteria

Inclusion Criteria:

· Adult patients (aged 18 years or over)

· Diagnosis of DCM

· Scheduled for surgery involving 2 or more laminae

Exclusion Criteria:

· Mild, non-progressive DCM (defined as a mJOA Score of >16)

· Presentation in the context of acute trauma

Unable to converse, read or write English at elementary school level

Follow up

Participants involvement in the trial will end upon completion of the 24-month follow up.

Any Serious Adverse Evenents which have not resolved will be clinically followed up until resolution outside of this trial.

Criteria for withdrawal of participants

A participant may withdraw their consent at any time.

Participants may also be withdrawn at the discretion of the investigator or sponsor, for the following reasons:

· Significant protocol deviation;

· An adverse event which results in inability to comply with trial procedures;

Cervical Degenerative Myelopathy disease activity, which results in inability to continue to comply with trial procedures